Federal Law dated 21.11.2011 N 323-FL On the Fundamentals of Health Protection of Citizens in the Russian Federation

21 November 2011 N 323-FL

 

RUSSIAN FEDERATION

FEDERAL LAW

ON THE FUNDAMENTALS OF THE PROTECTION OF THE HEALTH OF CITIZENS IN THE RUSSIAN FEDERATION

 

(as amended by Federal Laws of 25.06.2012 N 89-FL, of 25.06.2012 N 93-FL, of 02.07.2013 N 167-FL, of 02.07.2013 N 185-FL, of 23.07.2013 N 205-FL, of 27.09.2013 N 253-FL, of 25.11.2013 N 317-FL, of 28.12.2013 N 386-FL, of 04.06.2014 N 145-FL, of 21.07.2014 N 205-FL, of 21.07.2014 N 243-FL, of 21.07.2014 N 246-FL, of 21.07.2014 N 256-FL, of 22.10.2014 N 314-FL, of 01.12.2014 N 418-FL, of 01.12.2014 N 419-FL, of 31.12.2014 N 519-FL, of 31.12.2014 N 532-FL, of 08.03.2015 N 33-FL, of 08.03.2015 N 55-FL, of 06.04.2015 N 78-FL, of 29.06.2015 N 160-FL, of 13.07.2015 N 213-FL, of 13.07.2015 N 230-FL, of 13.07.2015 N 233-FL, of 13.07.2015 N 271-FL, of 14.12.2015 N 374-FL, of 29.12.2015 N 389-FL, of 29.12.2015 N 408-FL, of 05.04.2016 N 93-FL, of 26.04.2016 N 112-FL, of 03.07.2016 N 286-FL, of 03.04.2017 N 61-FL, of 01.05.2017 N 86-FL, of 01.07.2017 N 154-FL, of 29.07.2017 N 216-FL, of 29.07.2017 N 242-FL, of 05.12.2017 N 373-FL, of 05.12.2017 N 392-FL, of 29.12.2017 N 465-FL, of 07.03.2018 N 56-FL, of 19.07.2018 N 208-FL, of 03.08.2018 N 299-FL, of 03.08.2018 N 309-FL, of 03.08.2018 N 323-FL, of 25.12.2018 N 489-FL, of 27.12.2018 N 511-FL, of 06.03.2019 N 18-FL, of 29.05.2019 N 119-FL, of 02.12.2019 N 399-FL, of 27.12.2019 N 452-FL, of 27.12.2019 N 478-FL, of 27.12.2019 N 481-FL, of 27.12.2019 N 518-FL, of 26.03.2020 N 67-FL, of 01.04.2020 N 93-FL, of 01.04.2020 N 98-FL, of 24.04.2020 N 147-FL, of 08.06.2020 N 166-FL, of 13.07.2020 N 206-FL, of 31.07.2020 N 271-FL, of 31.07.2020 N 303-FL, of 08.12.2020 N 429-FL, of 22.12.2020 N 438-FL, of 30.04.2021 N 126-FL (as amended on 26.05.2021), of 30.04.2021 N 128-FL, of 30.04.2021 N 129-FL, of 30.04.2021 N 131-FL, of 26.05.2021 N 152-FL, of 11.06.2021 N 170-FL, of 02.07.2021 N 312-FL, of 02.07.2021 N 313-FL, of 02.07.2021 N 314-FL, of 02.07.2021 N 315-FL, of 02.07.2021 N 331-FL, of 02.07.2021 N 358-FL, of 30.12.2021 N 482-FL, of 08.03.2022 N 46-FL, of 26.03.2022 N 64-FL, of 01.05.2022 N 129-FL, of 11.06.2022 N 166-FL, of 14.07.2022 N 271-FL, of 14.07.2022 N 275-FL, of 14.07.2022 N 317-FL, of 05.12.2022 N 469-FL, of 19.12.2022 N 538-FL, of 28.12.2022 N 569-FL, of 29.12.2022 N 629-FL, of 14.04.2023 N 135-FL, of 28.04.2023 N 174-FL, of 13.06.2023 N 256-FL, of 24.07.2023 N 386-FL, of 04.08.2023 N 462-FL of 04.08.2023 N 464-FL, of 04.08.2023 N 469-FL, of 25.12.2023 N 625-FL, of 25.12.2023 N 635-FL, of 25.12.2023 N 678-FL, of 22.07.2024 N 195-FL, of 08.08.2024 N 232-FL, of 08.08.2024 N 290-FL, of 08.08.2024 N 306-FL, of 08.08.2024 N 323-FL, of 28.12.2024 N 509-FL, of 28.12.2024 N 554-FL, of 07.04.2025 N 65-FL, of 07.06.2025 N 150-FL, of 23.07.2025 N 239-FL, of 23.07.2025 N 252-FL,of 23.07.2025 N 261-FL, of 31.07.2025 N 304-FL, of 17.11.2025 N 424-FL, of 28.12.2025 N 515-FL, of 29.12.2025 N 550-FL, of 25.04.2026 N 114-FL, of 04.08.2026 N 329-FL)

 

Adopted

by the State Duma

on 1 November 2011

 

Approved

by the Federation Council

on 9 November 2011

 

Chapter 1. GENERAL PROVISIONS

 

Article 1. Subject Matter of Regulation of this Federal Law

This Federal Law regulates the relations arising in the sphere of the protection of the health of citizens in the Russian Federation (hereinafter – in the sphere of health protection), and determines:

1) the legal, organizational and economic fundamentals of the protection of the health of citizens;

2) the rights and duties of man and citizen, of certain groups of the population in the sphere of health protection, the guarantees of the realization of these rights;

3) the powers and responsibility of bodies of state power of the Russian Federation, bodies of state power of constituent entities of the Russian Federation and local self-government bodies in the sphere of health protection;

4) the rights and duties of medical organizations, other organizations, individual entrepreneurs in the carrying out of activities in the sphere of health protection;

5) the rights and duties of medical workers and pharmaceutical workers.

 

Article 2. Basic Concepts Used in this Federal Law

1. For the purposes of this Federal Law, the following basic concepts are used: (as amended by Federal Law of 02.07.2021 N 331-FL)

1) health – a state of physical, mental and social well-being of a person in which there are no diseases, and also no disorders of the functions of organs and systems of the organism;

2) protection of the health of citizens (hereinafter – health protection) – a system of measures of a political, economic, legal, social, scientific, medical, including sanitary and anti-epidemic (preventive), nature carried out by bodies of state power of the Russian Federation, bodies of state power of constituent entities of the Russian Federation, local self-government bodies, organizations, their officials and other persons, citizens for the purposes of the prevention of diseases, the preservation and strengthening of the physical and mental health of each person, the maintenance of his long-term active life, the provision of medical care to him;

3) medical care – a set of measures aimed at the maintenance and (or) restoration of health and including the provision of medical services;

4) medical service – a medical intervention or a set of medical interventions aimed at the prevention, diagnosis and treatment of diseases, medical rehabilitation and having independent complete significance;

5) medical intervention – types of medical examinations and (or) medical manipulations performed by a medical worker and another worker having the right to carry out medical activity in relation to a patient, affecting the physical or mental state of a person and having a preventive, research, diagnostic, therapeutic, rehabilitation orientation, and also the artificial termination of pregnancy; (as amended by Federal Law of 29.12.2015 N 389-FL)

6) prevention – a set of measures aimed at the preservation and strengthening of health and including the formation of a healthy lifestyle, the prevention of the occurrence and (or) spread of diseases, their early detection, the identification of the causes and conditions of their occurrence and development, and also aimed at the elimination of the harmful influence on human health of the factors of his habitat;

7) diagnosis – a set of medical interventions aimed at the recognition of states or the establishment of the fact of the presence or absence of diseases, carried out by means of the collection and analysis of the complaints of the patient, the data of his anamnesis and examination, the conduct of laboratory, instrumental, pathologic-anatomical and other studies for the purposes of determining the diagnosis, choosing measures for the treatment of the patient and (or) control over the carrying out of these measures;

8) treatment – a set of medical interventions performed on the prescription of a medical worker, the purpose of which is the elimination or alleviation of the manifestations of a disease or diseases or states of the patient, the restoration or improvement of his health, working capacity and quality of life;

9) patient – a natural person to whom medical care is provided or who has applied for the provision of medical care, irrespective of whether he has a disease and of his state;

10) medical activity – professional activity in the provision of medical care, the conduct of medical expert examinations, medical examinations and medical certifications, sanitary and anti-epidemic (preventive) measures and professional activity related to the transplantation (grafting) of organs and (or) tissues, the circulation of donor blood and (or) its components for medical purposes;

11) medical organization – a legal entity, irrespective of its organizational and legal form, carrying out medical activity as the main (statutory) type of activity on the basis of a licence granted in the procedure established by the legislation of the Russian Federation on the licensing of certain types of activity. The provisions of this Federal Law regulating the activities of medical organizations extend to other legal entities, irrespective of their organizational and legal form, carrying out medical activity along with their main (statutory) activity, and apply to such organizations in the part concerning medical activity. For the purposes of this Federal Law, individual entrepreneurs carrying out medical activity are equated to medical organizations; (as amended by Federal Laws of 29.12.2015 N 408-FL, of 27.12.2019 N 478-FL)

12) pharmaceutical organization – a legal entity, irrespective of its organizational and legal form, carrying out pharmaceutical activity (an organization of wholesale trade in medicines, a pharmacy organization). For the purposes of this Federal Law, individual entrepreneurs carrying out pharmaceutical activity are equated to pharmaceutical organizations;

13) medical worker – a natural person who has medical or other education, works in a medical organization in a position included in the nomenclature of positions of medical workers and pharmaceutical workers, and whose labour (job) duties include the carrying out of medical activity, or a natural person who is an individual entrepreneur directly carrying out medical activity; (as amended by Federal Law of 08.08.2024 N 290-FL)

14) pharmaceutical worker – a natural person who has pharmaceutical education, works in a pharmaceutical organization and whose labour duties include wholesale trade in medicines, their storage, transportation and (or) retail trade in medicinal products for medical use (hereinafter – medicinal products), their manufacture, dispensing, storage and transportation;

15) attending physician – a physician who is entrusted with the functions of organizing and directly providing medical care to a patient during the period of observation of him and his treatment;

16) disease – a disorder of the activity of the organism, of working capacity, of the ability to adapt to the changing conditions of the external and internal environment, arising in connection with the influence of pathogenic factors, with a simultaneous change in the protective-compensatory and protective-adaptive reactions and mechanisms of the organism;

17) state – changes in the organism arising in connection with the influence of pathogenic and (or) physiological factors and requiring the provision of medical care;

18) underlying disease – a disease which by itself or in connection with complications causes the primary necessity of the provision of medical care in connection with the greatest threat to working capacity, life and health, or leads to disability, or becomes the cause of death;

19) concomitant disease – a disease which has no cause-and-effect relationship with the underlying disease, is inferior to it in the degree of necessity of the provision of medical care, of influence on working capacity, of danger to life and health, and is not the cause of death;

20) severity of a disease or state – a criterion determining the degree of damage to organs and (or) systems of the human organism or of disorder of their functions caused by a disease or state or their complication;

21) quality of medical care – a set of characteristics reflecting the timeliness of the provision of medical care, the correctness of the choice of methods of prevention, diagnosis, treatment and rehabilitation in the provision of medical care, the degree of achievement of the planned result;

22) telemedicine technologies – information technologies ensuring the remote interaction of medical workers among themselves, with patients and (or) their legal representatives, the identification and authentication of the said persons, the documenting of the actions performed by them in the conduct of consultations of physicians (konsiliums), consultations, remote medical observation of the state of health of a patient; (as amended by Federal Law of 29.07.2017 N 242-FL)

23) clinical guidelines – documents containing structured information based on scientific evidence on matters of prevention, diagnosis, treatment and rehabilitation, including protocols for patient management, variants of medical intervention and a description of the sequence of actions of a medical worker taking into account the course of the disease, the presence of complications and concomitant diseases, other factors affecting the results of the provision of medical care. (as amended by Federal Law of 25.12.2018 N 489-FL, of 23.07.2025 N 261-FL)

24) registration certificate for a medical device – an entry in the state register of medical devices and organizations (individual entrepreneurs) carrying out the production and manufacture of medical devices, confirming the fact of the state registration of the medical device in the procedure established by the Government of the Russian Federation. (as amended by Federal Law of 31.07.2025 N 304-FL)

2. The concepts specified in this Article may be specified in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Law of 02.07.2021 N 331-FL)

 

Article 3. Legislation in the Sphere of Health Protection

1. The legislation in the sphere of health protection is based on the Constitution of the Russian Federation and consists of this Federal Law, other federal laws adopted in accordance with it, other normative legal acts of the Russian Federation, laws and other normative legal acts of constituent entities of the Russian Federation.
2. Norms on health protection contained in other federal laws, other normative legal acts of the Russian Federation, laws and other normative legal acts of constituent entities of the Russian Federation must not contradict the norms of this Federal Law.
3. In the event of non-conformity of norms on health protection contained in other federal laws, other normative legal acts of the Russian Federation, laws and other normative legal acts of constituent entities of the Russian Federation with the norms of this Federal Law, the norms of this Federal Law apply.
4. Local self-government bodies, within the limits of their competence, have the right to issue municipal legal acts containing norms on health protection in accordance with this Federal Law, other federal laws, other normative legal acts of the Russian Federation, laws and other normative legal acts of constituent entities of the Russian Federation.
5. If an international treaty of the Russian Federation establishes rules other than those provided for by this Federal Law in the sphere of health protection, the rules of the international treaty apply.

5.1. Decisions of interstate bodies adopted on the basis of provisions of international treaties of the Russian Federation in their interpretation contradicting the Constitution of the Russian Federation are not subject to execution in the Russian Federation. Such a contradiction may be established in the procedure determined by a federal constitutional law. (as amended by Federal Law of 08.12.2020 N 429-FL)

6. The legislation in the sphere of health protection in respect of organizations carrying out medical activity in the territories of advanced development applies taking into account the specifics established by the Federal Law “On the Territories of Advanced Development in the Russian Federation”. (as amended by Federal Laws of 31.12.2014 N 519-FL, of 14.07.2022 N 271-FL)
7. The legislation in the sphere of health protection in respect of organizations located in the territory of the international medical cluster and carrying out medical activity applies taking into account the specifics established by the Federal Law “On the International Medical Cluster and the Introduction of Amendments to Certain Legislative Acts of the Russian Federation”. (as amended by Federal Law of 29.06.2015 N 160-FL)
8. The legislation in the sphere of health protection in respect of organizations carrying out medical activity in the territory of the free port of Vladivostok applies taking into account the specifics established by the Federal Law “On the Free Port of Vladivostok”. (as amended by Federal Law of 13.07.2015 N 213-FL)
9. The legislation in the sphere of health protection in respect of organizations carrying out medical activity in the territories of innovation scientific and technological centres applies taking into account the specifics established by the Federal Law “On Innovation Scientific and Technological Centres and on the Introduction of Amendments to Certain Legislative Acts of the Russian Federation”. (as amended by Federal Law of 29.07.2017 N 216-FL)
10. Normative legal acts adopted in accordance with this Federal Law and establishing mandatory requirements (except for standards and procedures for the provision of medical care) enter into force within the terms provided for by Federal Law of 31 July 2020 N 247-FL “On Mandatory Requirements in the Russian Federation”. Normative legal acts establishing mandatory requirements in the regulations on the organization of the provision of medical care by types of medical care, in the rules for the conduct of expert examinations, laboratory, instrumental, pathologic-anatomical and other diagnostic studies in the event of the identification of the necessity to conduct the said studies for the purposes of preventing a threat to the life and health of citizens, and also in the procedures for the conduct of preventive medical examinations and dispanserization, may provide for other terms of their entry into force. (as amended by Federal Laws of 11.06.2021 N 170-FL, of 23.07.2025 N 261-FL)
11. In accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”, special regulation differing from the regulation provided for by the provisions of this Federal Law may be established in the field of the legislation in the sphere of health protection. Such special regulation is established by a programme of an experimental legal regime in the sphere of digital innovations approved by the Government of the Russian Federation in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. The provisions of this programme establishing the conditions of the experimental legal regime in the sphere of digital innovations may change or exclude the operation of provisions of this Federal Law if this is expressly provided for by this Federal Law, and must contain, among other things, a list of services, including services provided with the use of telemedicine technologies, in respect of which special regulation will be established, and also the type of liability applied to the subjects of the experimental legal regime in the sphere of digital innovations, with an indication of the conditions of its occurrence. (as amended by Federal Law of 02.07.2021 N 331-FL)

 

Chapter 2. BASIC PRINCIPLES OF HEALTH PROTECTION

 

Article 4. Basic Principles of Health Protection

The basic principles of health protection are:

1) the observance of the rights of citizens in the sphere of health protection and the ensuring of the state guarantees related to these rights;

2) the priority of the interests of the patient in the provision of medical care;

3) the priority of the protection of the health of children;

4) the social protection of citizens in the event of loss of health;

5) the responsibility of bodies of state power and local self-government bodies, of officials of organizations for ensuring the rights of citizens in the sphere of health protection;

6) the accessibility and quality of medical care;

7) the inadmissibility of refusal to provide medical care;

8) the priority of prevention in the sphere of health protection;

9) the observance of medical secrecy.

 

Article 5. Observance of the Rights of Citizens in the Sphere of Health Protection and Ensuring of the State Guarantees Related to These Rights

1. Measures for health protection must be carried out on the basis of the recognition, observance and protection of the rights of citizens and in accordance with the generally recognized principles and norms of international law.
2. The state ensures health protection to citizens irrespective of sex, race, age, nationality, language, the presence of diseases, states, origin, property and official status, place of residence, attitude to religion, convictions, membership in public associations and of other circumstances.
3. The state guarantees to citizens protection against any forms of discrimination caused by their having any diseases.

 

Article 6. Priority of the Interests of the Patient in the Provision of Medical Care

1. The priority of the interests of the patient in the provision of medical care is realized by means of:

1) the observance of ethical and moral norms, and also a respectful and humane attitude on the part of medical workers and other workers of the medical organization;

2) the provision of medical care to the patient taking into account his physical state and with observance, where possible, of the cultural and religious traditions of the patient;

3) the ensuring of care in the provision of medical care;

4) the organization of the provision of medical care to the patient taking into account the rational use of his time;

5) the establishment of requirements for the design and location of medical organizations taking into account the observance of sanitary and hygienic norms and the ensuring of comfortable conditions of stay of patients in medical organizations;

6) the creation of conditions ensuring the possibility of visiting the patient, including by a clergyman, and of the stay of relatives with him in the medical organization, taking into account the state of the patient, the observance of the anti-epidemic regime and the interests of other persons working and (or) staying in the medical organization. (as amended by Federal Law of 08.08.2024 N 290-FL)

2. For the purposes of realizing the principle of the priority of the interests of the patient in the provision of medical care, bodies of state power of the Russian Federation, bodies of state power of constituent entities of the Russian Federation, local self-government bodies exercising powers in the sphere of health protection, and medical organizations, within the limits of their competence, interact with public associations, other non-commercial organizations carrying out their activities in the sphere of health protection.

 

Article 7. Priority of the Protection of the Health of Children

1. The state recognizes the protection of the health of children as one of the most important and necessary conditions of the physical and mental development of children.
2. Children, irrespective of their family and social well-being, are subject to special protection, including care for their health and proper legal protection in the sphere of health protection, and have priority rights in the provision of medical care.
3. Medical organizations, organizations carrying out educational activity, public associations and other organizations are obliged to recognize and observe the rights of children in the sphere of health protection. (as amended by Federal Law of 13.06.2023 N 256-FL)
4. Bodies of state power of the Russian Federation, bodies of state power of constituent entities of the Russian Federation and local self-government bodies, in accordance with their powers, develop and implement programmes aimed at the prevention, early detection and treatment of diseases, the reduction of maternal and infant mortality, the formation in children and their parents of motivation for a healthy lifestyle, and take appropriate measures for the organization of the provision of children with medicinal products, specialized therapeutic nutrition products, medical devices.
5. Bodies of state power of the Russian Federation and bodies of state power of constituent entities of the Russian Federation, in accordance with their powers, create and develop medical organizations providing medical care to children, taking into account the ensuring of favourable conditions for the stay of children in them, including disabled children, and of the possibility of the stay of parents and (or) other family members with them, and also social infrastructure oriented towards organized recreation, health improvement of children and the restoration of their health.

 

Article 8. Social Protection of Citizens in the Event of Loss of Health

The social protection of citizens in the event of loss of health is ensured by means of the establishment and implementation of legal, economic, organizational, medical-social and other measures guaranteeing social security, including at the expense of the funds of compulsory social insurance, the determination of the need of a citizen for social protection in accordance with the legislation of the Russian Federation, for rehabilitation and care in the event of a disease (state), the establishment of temporary incapacity for work, disability or in other cases determined by the legislation of the Russian Federation.

 

Article 9. Responsibility of Bodies of State Power and Local Self-Government Bodies, of Officials of Organizations for Ensuring the Rights of Citizens in the Sphere of Health Protection

1. Bodies of state power and local self-government bodies, medical organizations, social service organizations and other organizations carry out interaction for the purposes of ensuring the rights of citizens in the sphere of health protection. (as amended by Federal Law of 06.03.2019 N 18-FL)
2. Bodies of state power and local self-government bodies, officials of organizations bear, within the limits of their powers, responsibility for ensuring the guarantees in the sphere of health protection established by the legislation of the Russian Federation.

 

Article 10. Accessibility and Quality of Medical Care

The accessibility and quality of medical care are ensured by:

1) the organization of the provision of medical care according to the principle of proximity to the place of residence, place of work or study;

2) the availability of the necessary number of medical workers and the level of their qualification;

3) the possibility of choosing a medical organization and a physician in accordance with this Federal Law;

4) the application of procedures for the provision of medical care, clinical guidelines and standards of medical care; (as amended by Federal Law of 25.12.2018 N 489-FL)

5) the provision by a medical organization of the guaranteed scope of medical care in accordance with the programme of state guarantees of the free provision of medical care to citizens;

6) the establishment, in accordance with the legislation of the Russian Federation, of requirements for the location of medical organizations of the state health care system and the municipal health care system and other infrastructure facilities in the sphere of health care based on the needs of the population;

7) the transport accessibility of medical organizations for all groups of the population, including disabled persons and other groups of the population with limited mobility;

8) the possibility of unimpeded and free use by a medical worker of means of communication or vehicles for the transportation of a patient to the nearest medical organization in cases threatening his life and health;

9) the equipping of medical organizations with equipment for the provision of medical care taking into account the special needs of disabled persons and other groups of the population with limited health capabilities; (as amended by Federal Law of 01.12.2014 N 419-FL)

10) the application of telemedicine technologies. (as amended by Federal Law of 29.07.2017 N 242-FL)

 

Article 11. Inadmissibility of Refusal to Provide Medical Care

1. Refusal to provide medical care in accordance with the programme of state guarantees of the free provision of medical care to citizens and the charging of a fee for its provision by a medical organization participating in the implementation of this programme and by medical workers of such medical organization are not permitted.
2. Medical care in emergency form is provided by a medical organization and a medical worker to a citizen without delay and free of charge. Refusal to provide it is not permitted.
3. For a violation of the requirements provided for by Parts 1 and 2 of this Article, medical organizations and medical workers bear liability in accordance with the legislation of the Russian Federation.

 

Article 12. Priority of Prevention in the Sphere of Health Protection

The priority of prevention in the sphere of health protection is ensured by means of:

1) the development and implementation of programmes for the formation of a healthy lifestyle, including programmes for the reduction of the consumption of alcohol, the consumption of tobacco or the consumption of nicotine-containing products, the prevention of and combating the non-medical consumption of narcotic drugs and psychotropic substances; (as amended by Federal Law of 31.07.2020 N 303-FL)

2) the carrying out of sanitary and anti-epidemic (preventive) measures;

3) the carrying out of measures for the prevention and early detection of diseases, including the prevention of and combating socially significant diseases; (as amended by Federal Law of 22.10.2014 N 314-FL)

4) the conduct of preventive and other medical examinations, dispanserization, dispensary observation in accordance with the legislation of the Russian Federation;

5) the carrying out of measures for the preservation of the life and health of citizens in the process of their study and labour activity in accordance with the legislation of the Russian Federation.

 

Article 13. Observance of Medical Secrecy

1. Information on the fact of a citizen applying for the provision of medical care, on the state of his health and diagnosis, other information obtained during his medical examination and treatment, constitute medical secrecy.

The interrelated provisions of Parts 2 and 3 of Article 13, Clause 5 of Part 5 of Article 19 and Part 1 of Article 20 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 7 (Part 2), 17, 19 (Parts 1 and 2), 21 (Part 1), 24, 29 (Part 4), 41 (Parts 1 and 3), 52 and 55 (Part 3), to the extent that, in the system of the current legal regulation, the uncertainty of their normative content does not make it possible to determine the conditions and procedure for access to the medical documentation of a deceased patient by his spouse, close relatives (family members) and (or) other persons specified in his informed voluntary consent to medical intervention (Resolution of the Constitutional Court of the RF of 13.01.2020 N 1-П).

2. The disclosure of information constituting medical secrecy, including after the death of a person, by persons to whom it became known in the course of training, the performance of labour, official, service and other duties is not permitted, except for the cases established by Parts 3 and 4 of this Article.

The interrelated provisions of Parts 2 and 3 of Article 13, Clause 5 of Part 5 of Article 19 and Part 1 of Article 20 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 7 (Part 2), 17, 19 (Parts 1 and 2), 21 (Part 1), 24, 29 (Part 4), 41 (Parts 1 and 3), 52 and 55 (Part 3), to the extent that, in the system of the current legal regulation, the uncertainty of their normative content does not make it possible to determine the conditions and procedure for access to the medical documentation of a deceased patient by his spouse, close relatives (family members) and (or) other persons specified in his informed voluntary consent to medical intervention (Resolution of the Constitutional Court of the RF of 13.01.2020 N 1-П).

3. The disclosure of information constituting medical secrecy to other citizens, including officials, for the purposes of the medical examination and treatment of the patient, the conduct of scientific research, its publication in scientific editions, use in the educational process and for other purposes is permitted with the written consent of the citizen or his legal representative. Consent to the disclosure of information constituting medical secrecy may also be expressed in the informed voluntary consent to medical intervention. (as amended by Federal Law of 02.07.2021 N 315-FL)

3.1. After the death of a citizen, the disclosure of information constituting medical secrecy to the spouse, close relatives (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfathers, grandmothers) or other persons specified by the citizen or his legal representative in the written consent to the disclosure of information constituting medical secrecy or in the informed voluntary consent to medical intervention, upon their request, is permitted if the citizen or his legal representative did not prohibit the disclosure of information constituting medical secrecy. (as amended by Federal Law of 02.07.2021 N 315-FL)

4. The provision of information constituting medical secrecy without the consent of the citizen or his legal representative is permitted:

1) for the purposes of the medical examination and treatment of a citizen who, as a result of his state, is unable to express his will, taking into account the provisions of Clause 1 of Part 9 of Article 20 of this Federal Law;

2) in the event of a threat of the spread of infectious diseases, mass poisonings and injuries;

3) upon the request of bodies of inquiry and investigation, a court in connection with the conduct of an investigation or judicial proceedings, upon the request of bodies of the prosecutor’s office in connection with their exercise of prosecutorial supervision, upon the request of a body of the penal enforcement system in connection with the execution of a criminal punishment and the exercise of control over the application of compulsory measures of a medical nature imposed in accordance with Part two.1 of Article 102 of the Criminal Code of the Russian Federation, over the behaviour of a conditionally convicted person, a convicted person in respect of whom the serving of the punishment has been deferred, and a person released on parole, and also in connection with the performance by a convicted person of the duty to undergo treatment for drug addiction and medical and (or) social rehabilitation, upon the request of internal affairs bodies in connection with the exercise of administrative supervision over persons released from places of deprivation of liberty, or in connection with participation in the observation of persons suffering from alcoholism and (or) drug addiction and posing a danger to others, of persons suffering from chronic and protracted mental disorders with severe persistent or frequently exacerbating painful manifestations, in respect of whom dispensary observation has been established in connection with the propensity of such persons to commit socially dangerous acts, for the purposes of preventing the commission by the said persons of crimes and administrative offences, and also in connection with the verification of statements and reports registered in the established procedure on crimes, administrative offences and incidents committed by persons suffering from chronic and protracted mental disorders with severe persistent or frequently exacerbating painful manifestations, in respect of whom dispensary observation has been established in connection with the propensity of such persons to commit socially dangerous acts, the resolution of which is assigned to the competence of the police; (as amended by Federal Laws of 23.07.2013 N 205-FL, of 01.04.2020 N 93-FL, of 22.07.2024 N 195-FL, of 28.12.2024 N 509-FL)

3.1) for the purposes of the exercise by the authorized federal executive bodies of control over the performance by persons recognized as suffering from drug addiction or consuming narcotic drugs or psychotropic substances without a physician’s prescription or new potentially dangerous psychoactive substances of the duty, imposed on them by a court when imposing an administrative punishment, to undergo treatment for drug addiction, diagnosis, preventive measures and (or) medical rehabilitation; (as amended by Federal Law of 13.07.2015 N 230-FL)

4) in the case of the provision of medical care to a minor in accordance with Clause 2 of Part 2 of Article 20 of this Federal Law, and also to a minor who has not reached the age established by Part 2 of Article 54 of this Federal Law, for the purpose of informing one of his parents or another legal representative;

5) for the purposes of informing internal affairs bodies: (as amended by Federal Law of 22.12.2020 N 438-FL)

а) of the admission of a patient in respect of whom there are sufficient grounds to believe that the harm to his health was caused as a result of unlawful acts; (as amended by Federal Law of 22.12.2020 N 438-FL)

б) of the admission of a patient who, due to his state of health, age or other reasons, cannot report data on his identity; (as amended by Federal Law of 22.12.2020 N 438-FL)

в) of the death of a patient whose identity has not been established; (as amended by Federal Law of 22.12.2020 N 438-FL)

г) of a person suffering from a mental disorder in respect of whom a court has imposed compulsory measures of a medical nature, or of a person suffering from a chronic and protracted mental disorder with severe persistent or frequently exacerbating painful manifestations, in respect of whom dispensary observation has been established in connection with the propensity of such person to commit socially dangerous acts; (as amended by Federal Law of 22.07.2024 N 195-FL)

6) for the purposes of the conduct of a military medical expert examination upon the requests of military commissariats, personnel services and military medical (medical flight) commissions of federal executive bodies and federal state bodies in which a federal law provides for military service and service equated to it; (as amended by Federal Law of 04.06.2014 N 145-FL)

7) for the purposes of the investigation of an industrial accident and an occupational disease, and also of an accident with a student during his stay in an organization carrying out educational activity, and, in accordance with Part 6 of Article 34.1 of Federal Law of 4 December 2007 N 329-FL “On Physical Culture and Sport in the Russian Federation”, of an accident with a person undergoing sports training and not being in labour relations with a physical culture and sports organization not carrying out sports training and being the customer of sports training services, during the undergoing by such person of sports training in an organization carrying out sports training, including during his participation in sports competitions provided for by the sports training programmes being implemented; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 06.04.2015 N 78-FL)

8) in the exchange of information by medical organizations, including information placed in medical information systems, for the purposes of the provision of medical care taking into account the requirements of the legislation of the Russian Federation on personal data;

9) for the purposes of the exercise of recording and control in the system of compulsory social insurance;

10) for the purposes of the exercise of control of the quality and safety of medical activity in accordance with this Federal Law;

11. Clause has ceased to be in force. (as amended by Federal Law of 25.11.2013 N 317-FL)

 

Chapter 3. POWERS OF FEDERAL BODIES OF STATE POWER, BODIES OF STATE POWER OF CONSTITUENT ENTITIES OF THE RUSSIAN FEDERATION AND LOCAL SELF-GOVERNMENT BODIES IN THE SPHERE OF HEALTH PROTECTION

 

Article 14. Powers of Federal Bodies of State Power in the Sphere of Health Protection

1. The powers of federal bodies of state power in the sphere of health protection include:

1) the pursuit of the unified state policy in the sphere of health protection;

2) the protection of the rights and freedoms of man and citizen in the sphere of health protection;

3) the management of federal state property used in the sphere of health protection;

4) the organization of the system of sanitary protection of the territory of the Russian Federation;

5) the organization, ensuring and exercise of federal state sanitary and epidemiological supervision;

6) the implementation of measures aimed at saving the lives and preserving the health of people in emergency situations, the elimination of the medical and sanitary consequences of emergency situations, the informing of the population about the medical and sanitary situation in the emergency zone and about the measures being taken;

7) the licensing of certain types of activity in the sphere of health protection, except for the licensing which is carried out in accordance with Part 1 of Article 15 of this Federal Law by bodies of state power of constituent entities of the Russian Federation; (as amended by Federal Law of 05.04.2016 N 93-FL)

8) the organization and exercise of control in the sphere of health protection, including over compliance with the requirements of technical regulations in the sphere of health protection;

9) the maintenance of federal information systems, federal databases in the sphere of health care, including the ensuring of the confidentiality of the personal data contained in them in accordance with the legislation of the Russian Federation;

10) the establishment of the procedure for the carrying out of medical activity on the principles of public-private partnership in the sphere of health protection;

11) the organization of the provision to citizens of primary health care, specialized, including high-tech, medical care, emergency, including emergency specialized, medical care and palliative medical care by medical organizations subordinate to federal executive bodies; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL)

11.1) the organization of the conduct of medical expert examinations, medical examinations and medical certifications in medical organizations subordinate to federal executive bodies; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL)

11.2) the organization of the provision of medical care within the framework of the clinical approbation of methods of prevention, diagnosis, treatment and rehabilitation (hereinafter – clinical approbation) by medical organizations subordinate to federal executive bodies; (as amended by Federal Law of 08.03.2015 N 55-FL)

11.3) the organization of medical activity related to the transplantation (grafting) of human organs and tissues, including to the donation of organs and tissues for the purposes of transplantation (grafting), in medical organizations subordinate to federal executive bodies; (as amended by Federal Law of 13.07.2015 N 271-FL)

11.4) the organization of the activities of national medical research centres subordinate to federal executive bodies; (as amended by Federal Law of 28.12.2025 N 515-FL)

12) the organization of the free-of-charge provision of donor blood and (or) its components, and also the organization of the provision of medicinal products, specialized therapeutic nutrition products, medical devices, means for disinfection, disinsection and deratization in the provision of medical care, the conduct of medical expert examinations, medical examinations and medical certifications in accordance with Clauses 6, 11 and 11.1 of this Part and Clause 17 of Part 2 of this Article; (as amended by Federal Law of 25.11.2013 N 317-FL)

13) the organization of the medical and biological support of athletes of the national sports teams of the Russian Federation, the approval of methodological guidelines on the organization of the medical and biological support of athletes of the sports teams of constituent entities of the Russian Federation (including athletes engaged in adaptive sports), developed by a medical organization subordinate to the federal executive body exercising powers for the organization of the medical and biological support of athletes of the national sports teams of the Russian Federation, and also the establishment of the procedure for the development of such methodological guidelines; (as amended by Federal Laws of 05.12.2017 N 373-FL, of 29.12.2025 N 550-FL)

14) the organization and exercise of control over the reliability of primary statistical data submitted by medical organizations;

15) the monitoring of the safety of medical devices, the registration of side effects not specified in the instructions for use or the operation manual of a medical device, of adverse reactions in its use, of the specifics of the interaction of medical devices with each other, of facts and circumstances creating a threat to the life and health of citizens and medical workers in the use and operation of medical devices (hereinafter – adverse events); (as amended by Federal Law of 30.04.2021 N 128-FL)

16) the ensuring of the development and implementation of programmes of scientific research in the sphere of health protection, their coordination;

17) the international cooperation of the Russian Federation in the sphere of health protection, including the conclusion of international treaties of the Russian Federation;

18) the preparation and submission to the chambers of the Federal Assembly of the Russian Federation, not later than 1 June of the year following the reporting year, of the annual state report on the implementation of state policy in the sphere of health protection in the procedure established by the Government of the Russian Federation; (as amended by Federal Law of 25.11.2013 N 317-FL)

19) the organization of the provision to persons infected with the human immunodeficiency virus, including in combination with hepatitis B and C viruses, of antiviral medicinal products for medical use included in the list of vital and essential medicinal products in accordance with Federal Law of 12 April 2010 N 61-FL “On the Circulation of Medicines”; (as amended by Federal Law of 03.07.2016 N 286-FL)

20) the organization of the provision to persons suffering from tuberculosis with multiple drug resistance of the pathogen of antibacterial and anti-tuberculosis medicinal products for medical use included in the list of vital and essential medicinal products in accordance with Federal Law of 12 April 2010 N 61-FL “On the Circulation of Medicines”; (as amended by Federal Law of 03.07.2016 N 286-FL)

21) the approval of the cases and procedure for the organization of the provision of primary health care and specialized, including high-tech, medical care by medical workers of medical organizations subordinate to federal executive bodies outside such medical organizations. (as amended by Federal Law of 26.03.2022 N 64-FL)

2. The powers of the federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of health care (hereinafter – the authorized federal executive body) include: (as amended by Federal Law of 25.11.2013 N 317-FL)

1) the pursuit of the unified state policy in the sphere of health care, the development and implementation of programmes for the formation of a healthy lifestyle and other programmes in the sphere of health protection, the implementation of measures for the development of health care, the prevention of diseases, the sanitary and epidemiological well-being of the population, the provision of medical care, the organization of medical activity related to the transplantation (grafting) of human organs and tissues, including to the donation of organs and tissues for the purposes of transplantation (grafting), sanitary and hygienic education; (as amended by Federal Law of 13.07.2015 N 271-FL)

2) the establishment of requirements for the location of medical organizations of the state health care system and the municipal health care system, other infrastructure facilities in the sphere of health care based on the needs of the population;

3) the coordination of the activities in the sphere of health protection of federal executive bodies, executive bodies of constituent entities of the Russian Federation, local self-government bodies, subjects of the state health care system, the municipal health care system and the private health care system; (as amended by Federal Law of 08.08.2024 N 232-FL)

3.1) the approval, in the procedure established by the Government of the Russian Federation, of the appointment to the position of the head of the executive body of a constituent entity of the Russian Federation in the sphere of health protection; (as amended by Federal Laws of 30.04.2021 N 129-FL, of 08.08.2024 N 232-FL)

4) the approval of the procedure for the creation and activities of the medical commission of a medical organization;

5) the approval of the relevant nomenclature in the sphere of health protection (of medical organizations, of bed capacity by profiles of medical care, of medical services, of positions of medical workers and pharmaceutical workers, of specialties of specialists having medical and pharmaceutical education);

5.1) the approval of qualification requirements for medical and pharmaceutical workers; (as amended by Federal Law of 17.11.2025 N 424-FL)

6) the approval of model regulations on certain types of medical organizations included in the nomenclature of medical organizations;

7) the establishment of general requirements for the structure and staff schedule of medical organizations forming part of the state and municipal health care systems;

8) the establishment of the procedure for the organization and conduct of medical expert examinations (except for medical and social expert examination and military medical expert examination); (as amended by Federal Law of 25.11.2013 N 317-FL)

9) the approval of the procedure for the organization and conduct of the expert examination of the quality, effectiveness and safety of medical devices;

10) the approval of rules and methods in the field of statistical accounting and reporting, of standards of information exchange in the sphere of health protection applied by medical organizations and pharmaceutical organizations;

11) the approval of the procedure for the organization of the document flow system in the sphere of health protection, of unified forms of medical documentation, including in the form of electronic documents, of the procedures for their maintenance; (as amended by Federal Law of 29.07.2017 N 242-FL)

11.1) the organization of the conduct of the accreditation of specialists; (as amended by Federal Law of 29.12.2015 N 389-FL)

12) the approval of the procedure for the attestation of specialists having higher and secondary medical and (or) pharmaceutical education for the assignment to them of a qualification category;

13) the approval of the procedure for the organization of the referral of citizens of the Russian Federation for treatment outside the territory of the Russian Federation at the expense of the funds of the federal budget;

14) the approval of the procedure for the conduct of medical examinations;

15) the approval of the list of occupational diseases;

16) the approval of the procedure for the prescription of medicinal products, medical devices, of the forms of prescription blanks for medicinal products, medical devices, of the procedure for filling in these blanks, their recording and storage; (as amended by Federal Law of 29.07.2017 N 242-FL)

17) the organization of the medical evacuation of citizens by medical organizations subordinate to federal executive bodies; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL)

18) the approval of the procedure for medical certification for the state of intoxication (alcoholic, narcotic or other toxic), including the determination of the clinical signs of intoxication and the rules for the conduct of chemical and toxicological studies; (as amended by Federal Law of 25.11.2013 N 317-FL)

19) the approval of the rules for the conduct of laboratory, instrumental, pathologic-anatomical and other types of diagnostic studies; (as amended by Federal Law of 25.11.2013 N 317-FL)

19.1) the approval of general requirements for the organization of visits to a patient by relatives and other family members or legal representatives of the patient in a medical organization, including in its structural subdivisions intended for intensive therapy and resuscitation measures, during the provision of medical care to him in inpatient conditions; (as amended by Federal Law of 29.05.2019 N 119-FL)

19.2) the approval of general requirements for the organization of visits to a patient by clergymen of centralized religious organizations and religious organizations forming part of their structure, for the purposes of performing divine services, other religious rites and ceremonies in a medical organization, including in its structural subdivisions intended for intensive therapy and resuscitation measures, during the provision of medical care to the patient in inpatient conditions. The general requirements also establish the specifics of the admission of clergymen to medical organizations subordinate to federal executive bodies in which a federal law provides for military service or service equated to it, and also to federal state bodies in which a federal law provides for military service or service equated to it, ensuring the safety of information constituting a state secret, and also of information on the departmental affiliation of patients undergoing treatment in inpatient conditions; (as amended by Federal Law of 08.08.2024 N 290-FL)

20) the creation of conditions for the organization of the conduct of an independent assessment of the quality of the conditions of the provision of services by medical organizations; (as amended by Federal Law of 21.07.2014 N 256-FL, of 05.12.2017 N 392-FL)

21) the organization of the provision with medicinal products of persons suffering from haemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, haemolytic-uraemic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis of types I, II and VI, aplastic anaemia, unspecified, hereditary deficiency of factors II (fibrinogen), VII (labile) X (Stuart-Prower), of persons after transplantation of organs and (or) tissues. (as amended by Federal Laws of 26.04.2016 N 112-FL, of 03.08.2018 N 299-FL, of 27.12.2019 N 452-FL)

 

Article 15. Transfer of the Exercise of Powers of the Russian Federation in the Sphere of Health Protection to Bodies of State Power of Constituent Entities of the Russian Federation

1. The Russian Federation transfers to bodies of state power of constituent entities of the Russian Federation the exercise of the following powers:

1) licensing (in the part of the granting of licences, the assessment of the compliance of licence applicants with licensing requirements, the assessment of the compliance of licensees with licensing requirements when introducing changes into the register of licences in the cases provided for by Federal Law of 4 May 2011 N 99-FL “On the Licensing of Certain Types of Activity”, the termination of licences, the formation and maintenance of registers of licences issued by bodies of state power of constituent entities of the Russian Federation, the approval of forms of applications for the granting of licences, for introducing changes into the register of licences, the approval of forms of notifications and other documents used in the licensing process, and also the provision to interested persons of information on licensing matters, including the placement of this information in the information and telecommunications network “Internet” on the official websites of bodies of state power of constituent entities of the Russian Federation with an indication of the e-mail addresses to which users of this information may send requests and receive the requested information) of the following types of activity: (as amended by Federal Law of 11.06.2021 N 170-FL)

а) the medical activity of medical organizations (except for medical organizations subordinate to federal executive bodies); (as amended by Federal Law of 01.12.2014 N 418-FL)

б) pharmaceutical activity (except for activity carried out by organizations of wholesale trade in medicines and pharmacy organizations subordinate to federal executive bodies); (as amended by Federal Law of 01.12.2014 N 418-FL)

в) activity in the turnover of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic-containing plants (in the part of activity in the turnover of narcotic drugs and psychotropic substances included in Lists I, II and III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, except for activity carried out by organizations of wholesale trade in medicines and pharmacy organizations subordinate to federal executive bodies); (as amended by Federal Law of 01.12.2014 N 418-FL)

2) clause excluded. (as amended by Federal Law of 26.04.2016 N 112-FL)

2. Funds for the exercise of the powers transferred in accordance with Part 1 of this Article are provided for in the form of subventions from the federal budget (hereinafter – subventions).
3. The total amount of funds provided for in the federal budget in the form of subventions to the budgets of constituent entities of the Russian Federation is determined on the basis of the following methods approved by the Government of the Russian Federation:

1) for the exercise of the power specified in Clause 1 of Part 1 of this Article based on:

а) the size of the population;

б) the number of medical organizations the exercise of the power of licensing of the medical activity of which has been transferred to bodies of state power of the constituent entity of the Russian Federation; the number of pharmacy organizations carrying out the sale to the population of medicinal products and medical devices, narcotic drugs, psychotropic substances and their precursors;

в) other indicators;

2) clause excluded. (as amended by Federal Law of 26.04.2016 N 112-FL)

4. Subventions are provided in accordance with the budget legislation of the Russian Federation.
5. Subventions for the exercise of the powers specified in Part 1 of this Article are of a targeted nature and may not be used for other purposes.
6. In the event of the use of subventions not for their intended purpose, the federal executive body exercising the functions of control and supervision in the financial and budgetary sphere is entitled to recover these funds in the procedure established by the legislation of the Russian Federation.
7. The authorized federal executive body:

1) issues normative legal acts on matters of the exercise of the powers specified in Part 1 of this Article, including administrative regulations for the provision of state services and the performance of state functions in the part of the transferred powers;

2) issues methodological guidelines and instructions on matters of the exercise of the transferred powers that are mandatory for execution by executive bodies of constituent entities of the Russian Federation; (as amended by Federal Law of 08.08.2024 N 232-FL)

3) clause has ceased to be in force. (as amended by Federal Law of 13.07.2015 N 233-FL)

4) establishes requirements for the content and forms of reporting, for the procedure for the submission of reporting on the exercise of the transferred powers;

4.1) approves, in accordance with the rules established by the Government of the Russian Federation, the procedure for the exercise of control over the effectiveness and quality of the exercise by bodies of state power of constituent entities of the Russian Federation of the powers specified in Part 1 of this Article; (as amended by Federal Law of 24.04.2020 N 147-FL)

5) prepares and submits to the Government of the Russian Federation, in the cases established by federal laws, proposals on the withdrawal of the transferred powers from bodies of state power of constituent entities of the Russian Federation.

8. Part has ceased to be in force. (as amended by Federal Law of 26.04.2016 N 112-FL)
9. The authorized federal executive body exercising the functions of control and supervision in the sphere of health protection:

1) maintains the unified register of licences, including licences granted by bodies of state power of constituent entities of the Russian Federation in accordance with the power specified in Clause 1 of Part 1 of this Article, in the procedure established by the authorized federal executive body; (as amended by Federal Law of 27.12.2019 N 478-FL)

2) exercises control over the effectiveness and quality of the exercise by bodies of state power of constituent entities of the Russian Federation of the powers specified in Part 1 of this Article, with the right to send orders on the elimination of identified violations and on bringing to responsibility the officials performing the duties of exercising the transferred powers; (as amended by Federal Law of 24.04.2020 N 147-FL)

3) ensures compliance with licensing requirements by licensees by means of the exercise of state control (supervision) (except for licensees that have submitted applications for introducing changes into the register of licences), exercises the powers of suspending, renewing and revoking licences, of submitting to the federal state information system, the procedure for the formation and maintenance of which is determined by the Government of the Russian Federation, information for the purposes of monitoring and assessing the effectiveness of the licensing of the types of activity specified in Clause 1 of Part 1 of this Article; (as amended by Federal Laws of 05.04.2016 N 93-FL, of 11.06.2021 N 170-FL)

4) sends within five working days to the bodies of state power of constituent entities of the Russian Federation exercising the powers specified in Part 1 of this Article certified copies of orders on the suspension and renewal of licences, on the appointment of inspections of licensees, copies of acts of inspections of licensees, of orders on the elimination of identified violations of licensing requirements, of protocols on administrative offences, of resolutions on the imposition of administrative punishments and of other documents related to ensuring compliance with licensing requirements by means of the exercise of state control (supervision) in respect of licensees (except for licensees that have submitted applications for introducing changes into the register of licences) carrying out the types of activity specified in Clause 1 of Part 1 of this Article, for inclusion in the licensing files. (as amended by Federal Laws of 05.04.2016 N 93-FL, of 11.06.2021 N 170-FL)

10. The highest official of a constituent entity of the Russian Federation: (as amended by Federal Law of 08.08.2024 N 232-FL)

1) appoints to the position (dismisses from the position) the heads of executive bodies of constituent entities of the Russian Federation exercising the powers transferred to them; (as amended by Federal Laws of 13.07.2015 N 233-FL, of 08.08.2024 N 232-FL)

2) approves the structure of executive bodies of constituent entities of the Russian Federation exercising the powers transferred to them; (as amended by Federal Laws of 13.07.2015 N 233-FL, of 08.08.2024 N 232-FL)

3) organizes activity for the exercise of the transferred powers in accordance with federal laws and other normative legal acts of the Russian Federation, the normative legal acts and other documents provided for by Part 7 of this Article;

4) is entitled, before the approval of the regulations specified in Clause 1 of Part 7 of this Article, to approve administrative regulations for the provision of state services and the performance of state functions in the part of the transferred powers, which may not contradict normative legal acts of the Russian Federation, must contain only the requirements and restrictions provided for by such acts in the part of the realization of the rights and freedoms of citizens, the rights and legitimate interests of organizations, and which are developed taking into account the requirements for regulations for the provision by federal executive bodies of state services and the performance of state functions;

5) ensures the timely submission to the authorized federal executive body, in the established form, of a quarterly report on the expenditure of the subventions provided, of data on the licences granted in accordance with the transferred powers, on the achievement of target forecast indicators in the event of their establishment, of copies of the normative legal acts issued by bodies of state power of constituent entities of the Russian Federation on matters of the transferred powers, and of other information provided for by normative legal acts of the authorized federal executive body; (as amended by Federal Law of 27.12.2019 N 478-FL)

6) clause has ceased to be in force. (as amended by Federal Law of 26.04.2016 N 112-FL)

11. Control over the expenditure of the subventions provided for the exercise of the transferred powers is exercised by the federal executive body exercising the functions of control and supervision in the financial and budgetary sphere, the federal executive body exercising control and supervision in the sphere of health care, and the Accounts Chamber of the Russian Federation.
12. Part has ceased to be in force. (as amended by Federal Law of 26.04.2016 N 112-FL)
13. The powers of federal executive bodies in the sphere of health protection provided for by this Federal Law may be transferred for exercise to executive bodies of constituent entities of the Russian Federation by resolutions of the Government of the Russian Federation in the procedure established by Federal Law of 21 December 2021 N 414-FL “On the General Principles of the Organization of Public Power in the Constituent Entities of the Russian Federation”. (as amended by Federal Laws of 13.07.2015 N 233-FL, of 08.08.2024 N 232-FL)

 

Article 16. Powers of Bodies of State Power of Constituent Entities of the Russian Federation in the Sphere of Health Protection

1. The powers of bodies of state power of constituent entities of the Russian Federation in the sphere of health protection include:

1) the protection of the rights of man and citizen in the sphere of health protection;

2) the development, approval and implementation of programmes for the development of health care, the ensuring of the sanitary and epidemiological well-being of the population, the prevention of diseases, the organization of the provision of citizens with medicinal products and medical devices, and also participation in the sanitary and hygienic education of the population;

3) the development, approval and implementation of the territorial programme of state guarantees of the free provision of medical care to citizens, including the territorial programme of compulsory medical insurance;

4) the formation of the structure of the executive bodies of a constituent entity of the Russian Federation exercising the powers in the sphere of health protection established by this Article, and the establishment of the procedure for their organization and activities; (as amended by Federal Law of 08.08.2024 N 232-FL)

5) the organization of the provision to the population of a constituent entity of the Russian Federation of primary health care, specialized, including high-tech, medical care, emergency, including emergency specialized, medical care and palliative medical care in medical organizations subordinate to executive bodies of the constituent entity of the Russian Federation; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 08.08.2024 N 232-FL)

5.1) the organization of the conduct of medical expert examinations, medical examinations and medical certifications in medical organizations subordinate to executive bodies of the constituent entity of the Russian Federation; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 08.08.2024 N 232-FL)

5.2) the organization of medical activity related to the transplantation (grafting) of human organs and tissues, including to the donation of organs and tissues for the purposes of transplantation (grafting), in medical organizations subordinate to executive bodies of the constituent entity of the Russian Federation; (as amended by Federal Laws of 13.07.2015 N 271-FL, of 08.08.2024 N 232-FL)

5.3) the organization of the activities of national medical research centres subordinate to executive bodies of the constituent entity of the Russian Federation; (as amended by Federal Law of 28.12.2025 N 515-FL)

6) the creation, within the limits of the competence determined by the legislation of the Russian Federation, of conditions for the development of medical care, the ensuring of its quality and accessibility; (as amended by Federal Law of 25.12.2018 N 489-FL)

7) the organization of the free-of-charge provision of donor blood and (or) its components, and also the organization of the provision of medicinal products, specialized therapeutic nutrition products, medical devices, means for disinfection, disinsection and deratization in the provision of medical care, the conduct of medical expert examinations, medical examinations and medical certifications in accordance with Clauses 5, 5.1 and 12 of this Part; (as amended by Federal Law of 25.11.2013 N 317-FL)

8) the organization of the carrying out of measures for the prevention of diseases and the formation of a healthy lifestyle among citizens residing in the territory of the constituent entity of the Russian Federation;

9) the organization of the carrying out of measures for disinfection, disinsection and deratization, and also of sanitary and anti-epidemic (preventive) measures in accordance with the legislation of the Russian Federation;

Clause 10 of Part 1 of Article 16 and Part 9 of Article 83 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 7, 18, 19 (Part 2), 21 (Part 1) and 41 (Part 1), to the extent that they do not provide for a reserve mechanism for the provision with medicines of persons suffering from diseases included in the list of life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of a citizen or to disability, in the case when the corresponding duty imposed on the constituent entity of the Russian Federation cannot be properly performed (Resolution of the Constitutional Court of the RF of 26.09.2024 N 41-П).

10) the organization of the provision of citizens with medicinal products and specialized therapeutic nutrition products for the treatment of diseases included in the list of life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of a citizen or to disability, provided for by Part 3 of Article 44 of this Federal Law; (as amended by Federal Law of 25.11.2013 N 317-FL)

11) the coordination of the activities of executive bodies of the constituent entity of the Russian Federation in the sphere of health protection, of subjects of the state, municipal and private health care systems in the territory of the constituent entity of the Russian Federation; (as amended by Federal Law of 08.08.2024 N 232-FL)

12) the implementation of measures aimed at saving the lives and preserving the health of people in emergency situations, the elimination of the medical and sanitary consequences of emergency situations, the informing of the population about the medical and sanitary situation in the emergency zone and about the measures being taken;

13) the informing of the population of the constituent entity of the Russian Federation, including through the mass media, about the possibility of the spread of socially significant diseases and diseases posing a danger to others in the territory of the constituent entity of the Russian Federation, carried out on the basis of annual statistical data, and also informing about the threat of the occurrence and about the occurrence of epidemics;

14) the establishment of measures of social support for the organization of the provision of medical care to persons suffering from socially significant diseases and diseases posing a danger to others, and for the organization of the provision of the said persons with medicinal products;

14.1) the creation of conditions for the employment of the persons specified in Part 3.3 of Article 69 of this Federal Law, including the establishment, within the limits of its powers, of additional measures of social support for the said persons; (as amended by Federal Law of 17.11.2025 N 424-FL)

15) the ensuring of the development and implementation of regional programmes of scientific research in the sphere of health protection, their coordination;

16) the establishment of the cases and procedure for the organization of the provision of primary health care and specialized medical care by medical workers of medical organizations outside such medical organizations, and also in other medical organizations;

17) the establishment of the procedure for the organization of the provision of primary health care in emergency and urgent forms, including at home upon calling a medical worker, to citizens who have chosen a medical organization for receiving primary health care within the framework of the programme of state guarantees of the free provision of medical care to citizens not according to the territorial-district principle; (as amended by Federal Law of 25.11.2013 N 317-FL)

18) the creation of conditions for the organization of the conduct of an independent assessment of the quality of the conditions of the provision of services by medical organizations; (as amended by Federal Laws of 21.07.2014 N 256-FL, of 05.12.2017 N 392-FL)

19) the organization of the medical and biological support of athletes of the sports teams of constituent entities of the Russian Federation; (as amended by Federal Law of 05.12.2017 N 373-FL)

20) the establishment of the procedure for the conduct of an assessment of the consequences of the adoption of a decision on the liquidation of a medical organization subordinate to an executive body of a constituent entity of the Russian Federation or a local self-government body, on the termination of the activities of its separate subdivision, and of the procedure for the creation of a commission for the assessment of the consequences of the adoption of such decision and the preparation of conclusions by the said commission. (as amended by Federal Laws of 29.12.2017 N 465-FL, of 08.08.2024 N 232-FL)

2. Certain powers of bodies of state power of constituent entities of the Russian Federation in the sphere of health protection specified in Part 1 of this Article may be transferred by them for exercise to local self-government bodies in accordance with Federal Law of 21 December 2021 N 414-FL “On the General Principles of the Organization of Public Power in the Constituent Entities of the Russian Federation”. In this case the provision of medical care to citizens is carried out by medical organizations of the municipal health care system. (as amended by Federal Law of 08.08.2024 N 232-FL)
3. The head of the executive body of a constituent entity of the Russian Federation in the sphere of health protection is appointed to the position by the highest official of the constituent entity of the Russian Federation in agreement with the authorized federal executive body. The period of the temporary performance of the duties of the head of the executive body of a constituent entity of the Russian Federation in the sphere of health protection may not exceed three months. (as amended by Federal Law of 25.04.2026 N 114-FL)

 

Article 17. Powers of Local Self-Government Bodies in the Sphere of Health Protection

The powers of local self-government bodies of municipal okrugs, urban okrugs and municipal districts (except for territories the medical care to the population of which is provided in accordance with Article 42 of this Federal Law) in the sphere of health protection include: (as amended by Federal Law of 26.05.2021 N 152-FL)

1) the creation of conditions for the provision of medical care to the population in accordance with the territorial programme of state guarantees of the free provision of medical care to citizens and the law of the constituent entity of the Russian Federation within the limits of the powers established by Federal Law of 6 October 2003 N 131-FL “On the General Principles of the Organization of Local Self-Government in the Russian Federation”;

2) the ensuring of the organization of the provision of medical care in medical organizations of the municipal health care system in the event of the transfer of the relevant powers in accordance with Part 2 of Article 16 of this Federal Law;

3) the informing of the population of the municipal formation, including through the mass media, about the possibility of the spread of socially significant diseases and diseases posing a danger to others in the territory of the municipal formation, carried out on the basis of annual statistical data, and also informing about the threat of the occurrence and about the occurrence of epidemics in accordance with the law of the constituent entity of the Russian Federation;

4) participation in the sanitary and hygienic education of the population and the promotion of the donation of blood and (or) its components;

5) participation in the implementation in the territory of the municipal formation of measures aimed at saving the lives and preserving the health of people in emergency situations, the informing of the population about the medical and sanitary situation in the emergency zone and about the measures being taken;

6) the implementation in the territory of the municipal formation of measures for the prevention of diseases and the formation of a healthy lifestyle in accordance with the law of the constituent entity of the Russian Federation;

7) the creation of favourable conditions for the purposes of attracting medical workers and pharmaceutical workers to work in medical organizations in accordance with Federal Law of 6 October 2003 N 131-FL “On the General Principles of the Organization of Local Self-Government in the Russian Federation”.

 

Chapter 4. RIGHTS AND DUTIES OF CITIZENS IN THE SPHERE OF HEALTH PROTECTION

 

Article 18. Right to Health Protection

1. Everyone has the right to health protection.
2. The right to health protection is ensured by the protection of the environment, the creation of safe working conditions, favourable conditions of work, everyday life, recreation, upbringing and education of citizens, the production and sale of food products of appropriate quality, of high-quality, safe and affordable medicinal products, and also by the provision of accessible and high-quality medical care. (as amended by Federal Law of 22.10.2014 N 314-FL)

 

Article 19. Right to Medical Care

1. Everyone has the right to medical care.
2. Everyone has the right to medical care in the guaranteed scope provided without charging a fee in accordance with the programme of state guarantees of the free provision of medical care to citizens, and also to receive paid medical services and other services, including in accordance with a voluntary medical insurance contract.
3. The right to medical care of foreign citizens residing and staying in the territory of the Russian Federation is established by the legislation of the Russian Federation and the relevant international treaties of the Russian Federation. Stateless persons permanently residing in the Russian Federation enjoy the right to medical care on an equal footing with citizens of the Russian Federation, unless otherwise provided for by international treaties of the Russian Federation.
4. The procedure for the provision of medical care to foreign citizens is determined by the Government of the Russian Federation.
5. The patient has the right to:

1) the choice of a physician and the choice of a medical organization in accordance with this Federal Law;

2) prevention, diagnosis, treatment, medical rehabilitation in medical organizations in conditions conforming to sanitary and hygienic requirements;

3) receiving consultations of specialist physicians;

4) the relief of pain associated with a disease, state and (or) medical intervention by methods and medicinal products, including narcotic medicinal products and psychotropic medicinal products; (as amended by Federal Law of 06.03.2019 N 18-FL)

The interrelated provisions of Parts 2 and 3 of Article 13, Clause 5 of Part 5 of Article 19 and Part 1 of Article 20 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 7 (Part 2), 17, 19 (Parts 1 and 2), 21 (Part 1), 24, 29 (Part 4), 41 (Parts 1 and 3), 52 and 55 (Part 3), to the extent that, in the system of the current legal regulation, the uncertainty of their normative content does not make it possible to determine the conditions and procedure for access to the medical documentation of a deceased patient by his spouse, close relatives (family members) and (or) other persons specified in his informed voluntary consent to medical intervention (Resolution of the Constitutional Court of the RF of 13.01.2020 N 1-П).

5) receiving information on his rights and duties, on the state of his health, the choice of persons to whom, in the interests of the patient, information on the state of his health may be transferred, including after his death; (as amended by Federal Law of 02.07.2021 N 315-FL)

6) receiving therapeutic nutrition in the event of the patient undergoing treatment in inpatient conditions;

7) the protection of information constituting medical secrecy;

8) refusal of medical intervention;

9) compensation for harm caused to health in the provision of medical care to him;

10) the admission to him of a lawyer or a legal representative for the protection of his rights;

11) the admission to him of clergymen of centralized religious organizations and religious organizations forming part of their structure, and in the event of the patient undergoing treatment in inpatient conditions – the provision of conditions for the performance of religious rites, the conduct of which is possible in inpatient conditions, including the provision of a separate room, if this does not violate the internal regulations of the medical organization, with observance of the general requirements established in accordance with Clause 19.2 of Part 2 of Article 14 of this Federal Law. (as amended by Federal Law of 08.08.2024 N 290-FL)

 

Article 20. Informed Voluntary Consent to Medical Intervention and to Refusal of Medical Intervention

The interrelated provisions of Part 2 of Article 13 and Part 1 of Article 20 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 7 (Part 2), 17, 19 (Parts 1 and 2), 21 (Part 1), 24, 29 (Part 4), 41 (Parts 1 and 3), 52 and 55 (Part 3), to the extent that, in the system of the current legal regulation, the uncertainty of their normative content does not make it possible to determine the conditions and procedure for access to the medical documentation of a deceased patient by his spouse, close relatives (family members) and (or) other persons specified in his informed voluntary consent to medical intervention (Resolution of the Constitutional Court of the RF of 13.01.2020 N 1-П).

1. A necessary precondition of medical intervention is the giving of the informed voluntary consent of a citizen or his legal representative to medical intervention on the basis of complete information provided by a medical worker in an accessible form on the purposes, methods of the provision of medical care, the risk associated with them, possible variants of medical intervention, its consequences, and also on the expected results of the provision of medical care.
2. Informed voluntary consent to medical intervention is given by one of the parents or another legal representative in respect of:

1) a person who has not reached the age established by Part 5 of Article 47 and Part 2 of Article 54 of this Federal Law, or a person recognized as legally incapable in the procedure established by law, if such person, due to his state, is unable to give consent to medical intervention;

2) a minor suffering from drug addiction in the provision of narcological care to him or in the medical certification of a minor for the purposes of establishing a state of narcotic or other toxic intoxication (except for the cases, established by the legislation of the Russian Federation, of minors acquiring full legal capacity before reaching the age of eighteen).

3. A citizen, one of the parents or another legal representative of a person specified in Part 2 of this Article, have the right to refuse medical intervention or to demand its termination, except for the cases provided for by Part 9 of this Article. The legal representative of a person recognized as legally incapable in the procedure established by law exercises the said right if such person, due to his state, is unable to refuse medical intervention.
4. In the event of refusal of medical intervention, the possible consequences of such refusal must be explained in a form accessible to him to the citizen, one of the parents or another legal representative of a person specified in Part 2 of this Article.
5. In the event of refusal by one of the parents or another legal representative of a person specified in Part 2 of this Article, or by the legal representative of a person recognized as legally incapable in the procedure established by law, of medical intervention necessary to save his life, the medical organization has the right to apply to a court for the protection of the interests of such person. The legal representative of a person recognized as legally incapable in the procedure established by law notifies the guardianship and trusteeship body at the place of residence of the ward of the refusal of medical intervention necessary to save the life of the ward not later than the day following the day of this refusal.
6. The persons specified in Parts 1 and 2 of this Article, for receiving primary health care, upon choosing a physician and a medical organization, for the term of their choice give informed voluntary consent to certain types of medical intervention which are included in the list established by the authorized federal executive body.
7. Informed voluntary consent to medical intervention or refusal of medical intervention is contained in the medical documentation of the citizen and is executed in the form of a document on paper signed by the citizen, one of the parents or another legal representative, a medical worker, or is generated in the form of an electronic document signed by the citizen, one of the parents or another legal representative with the use of an enhanced qualified electronic signature or a simple electronic signature by means of the use of the unified identification and authentication system, and also by a medical worker with the use of an enhanced qualified electronic signature. The informed voluntary consent to medical intervention or refusal of medical intervention of one of the parents or another legal representative of a person specified in Part 2 of this Article may be generated in the form of an electronic document if the medical documentation of the patient contains information on his legal representative. When executing informed voluntary consent to medical intervention, the citizen or his legal representative is entitled to determine the persons to whom, in the interests of the patient, information on the state of his health may be transferred, including after his death. The operation of these requirements in respect of the method of signing informed voluntary consent to medical intervention or refusal of medical intervention in the form of an electronic document may be changed in respect of participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Laws of 29.07.2017 N 242-FL, of 02.07.2021 N 315-FL, of 02.07.2021 N 331-FL)
8. The procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention, including in respect of certain types of medical intervention, the form of informed voluntary consent to medical intervention and the form of refusal of medical intervention are approved by the authorized federal executive body. (as amended by Federal Law of 25.11.2013 N 317-FL)
9. Medical intervention without the consent of the citizen, one of the parents or another legal representative is permitted:

1) if medical intervention is necessary on emergency indications to eliminate a threat to the life of a person and if his state does not allow him to express his will or there are no legal representatives (in respect of the persons specified in Part 2 of this Article);

1.1) in the case of the provision of emergency medical care outside a medical organization, if medical intervention is necessary to eliminate a threat to the life of a person and there is no refusal of the citizen (his legal representative) of medical intervention expressed before the commencement of the provision of medical care; (as amended by Federal Law of 25.12.2023 N 678-FL)

2) in respect of persons suffering from diseases posing a danger to others;

3) in respect of persons suffering from severe mental disorders;

4) in respect of persons who have committed socially dangerous acts (crimes); (as amended by Federal Law of 22.07.2024 N 195-FL)

5) in the conduct of a forensic medical expert examination and (or) a forensic psychiatric expert examination;

6) in the provision of palliative medical care, if the state of the citizen does not allow him to express his will and there is no legal representative. (as amended by Federal Law of 06.03.2019 N 18-FL)

10. The decision on medical intervention without the consent of the citizen, one of the parents or another legal representative is taken:

1) in the cases specified in Clauses 1 and 2 of Part 9 of this Article – by a consultation of physicians (konsilium), and if it is impossible to convene a konsilium – directly by the attending (on-duty) physician with the entry of such decision into the medical documentation of the patient and the subsequent notification of officials of the medical organization (the head of the medical organization or the head of a department of the medical organization), the citizen in respect of whom the medical intervention was carried out, one of the parents or another legal representative of the person who is specified in Part 2 of this Article and in respect of whom the medical intervention was carried out, or by a court in the cases and in the procedure which are established by the legislation of the Russian Federation; (as amended by Federal Law of 25.11.2013 N 317-FL)

2) in respect of the persons specified in Clauses 3 and 4 of Part 9 of this Article – by a court in the cases and in the procedure which are established by the legislation of the Russian Federation;

3) in the case specified in Clause 6 of Part 9 of this Article – by the medical commission or, if it is impossible to convene the medical commission, – by a konsilium of physicians or directly by the attending (on-duty) physician with the entry of such decision into the medical documentation of the patient and the subsequent notification of officials of the medical organization (the head of the medical organization or the head of a department of the medical organization), the citizen in respect of whom the medical intervention was carried out, one of the parents or another legal representative of the person who is specified in Part 2 of this Article and in respect of whom the medical intervention was carried out; (as amended by Federal Law of 06.03.2019 N 18-FL)

4) in the case specified in Clause 1.1 of Part 9 of this Article – by a medical worker of a mobile team of emergency, including emergency specialized, medical care with the entry into the medical documentation of the patient of the decision on the carrying out of medical intervention without the giving by the citizen (his legal representative) of informed voluntary consent to medical intervention. (as amended by Federal Law of 25.12.2023 N 678-FL)

11. Compulsory measures of a medical nature may be applied to persons who have committed crimes on the grounds and in the procedure which are established by a federal law.
12. In the case of the provision of medical care to a minor, the attending physician is obliged to inform the minor who has reached the age established by Part 2 of Article 54 of this Federal Law, one of the parents or another legal representative of a minor who has not reached this age, of the medicinal product being applied, including one applied in accordance with indicators (characteristics) of the medicinal product not specified in the instructions for its use, of its safety, expected effectiveness, the degree of risk for the patient, and also of the actions of the patient in the event of unforeseen effects of the influence of the medicinal product on the state of health of the patient. (as amended by Federal Law of 30.12.2021 N 482-FL)

 

Article 21. Choice of a Physician and a Medical Organization

1. In the provision of medical care to a citizen within the framework of the programme of state guarantees of the free provision of medical care to citizens, he has the right to choose a medical organization in the procedure approved by the authorized federal executive body, and to choose a physician taking into account the consent of the physician. The specifics of the choice of a medical organization by citizens residing in closed administrative-territorial formations, in territories with physical, chemical and biological factors dangerous to human health included in the relevant list, and also by workers of organizations included in the list of organizations of certain industries with especially dangerous working conditions, are established by the Government of the Russian Federation.
2. For receiving primary health care, a citizen chooses a medical organization, including according to the territorial-district principle, not more often than once a year (except for cases of a change of the place of residence or place of stay of the citizen). In the chosen medical organization, the citizen carries out, not more often than once a year (except for cases of replacement of the medical organization), the choice of a general practitioner (therapist), a district general practitioner (therapist), a paediatrician, a district paediatrician, a general practice physician (family physician) or a feldsher by submitting an application in person or through his representative addressed to the head of the medical organization.
3. The provision of primary specialized health care is carried out:

1) on the referral of a district general practitioner (therapist), a district paediatrician, a general practice physician (family physician), a feldsher, a specialist physician;

2) in the event of the citizen independently applying to a medical organization, including an organization chosen by him in accordance with Part 2 of this Article, taking into account the procedures for the provision of medical care.

4. For receiving specialized medical care in planned form, the choice of a medical organization is carried out on the referral of the attending physician. If several medical organizations providing medical care in the relevant profile participate in the implementation of the territorial programme of state guarantees of the free provision of medical care to citizens, the attending physician is obliged to inform the citizen of the possibility of choosing a medical organization taking into account the fulfilment of the conditions of the provision of medical care established by the territorial programme of state guarantees of the free provision of medical care to citizens.
5. Medical care in urgent or emergency form is provided to citizens taking into account compliance with the established requirements for the terms of its provision.
6. In the provision of medical care to a citizen within the framework of the programme of state guarantees of the free provision of medical care to citizens, the choice of a medical organization (except for cases of the provision of emergency medical care) outside the territory of the constituent entity of the Russian Federation in which the citizen resides is carried out in the procedure established by the authorized federal executive body.
7. When choosing a physician and a medical organization, a citizen has the right to receive information in a form accessible to him, including information placed in the information and telecommunications network “Internet” (hereinafter – the “Internet” network), about the medical organization, about the medical activity carried out by it and about the physicians, about the level of their education and qualification.
8. The choice of a physician and a medical organization by military servicemen and persons equated to military servicemen in terms of medical support, citizens undergoing alternative civilian service, citizens subject to conscription for military service or being sent to alternative civilian service, and citizens entering military service under contract or service equated to it, is carried out taking into account the specifics of the provision of medical care established by Article 25 of this Federal Law, and also taking into account the specifics established by Federal Law of 28 March 1998 N 53-FL “On Military Duty and Military Service”. (as amended by Federal Law of 30.04.2021 N 131-FL)

8.1. The choice of a physician and a medical organization by persons who have been detained, taken into custody, are serving a punishment in the form of restriction of liberty, arrest, deprivation of liberty or administrative arrest is carried out taking into account the specifics of the provision of medical care established by Article 26 of this Federal Law. (as amended by Federal Law of 30.04.2021 N 131-FL)

9. In the provision of medical care to citizens within the framework of the practical training of students under professional educational programmes of medical education, the patient must be informed of the participation of students in the provision of medical care to him and is entitled to refuse the participation of students in the provision of medical care to him. In this case the medical organization is obliged to provide medical care to such patient without the participation of students. (as amended by Federal Law of 02.07.2013 N 185-FL)

 

Article 22. Information on the State of Health

1. Everyone has the right to receive, in a form accessible to him, the information available in the medical organization on the state of his health, including data on the results of the medical examination, the presence of a disease, the established diagnosis and the prognosis of the development of the disease, the methods of the provision of medical care, the risk associated with them, possible types of medical intervention, its consequences and the results of the provision of medical care.
2. Information on the state of health is provided to the patient personally by the attending physician or other medical workers directly participating in the medical examination and treatment. In respect of persons who have not reached the age established in Part 2 of Article 54 of this Federal Law, and of citizens recognized as legally incapable in the procedure established by law, information on the state of health is provided to their legal representatives. In respect of persons who have reached the age established by Part 2 of Article 54 of this Federal Law but have not acquired full legal capacity, information on the state of health is provided to these persons, and also, until these persons reach the age of majority, to their legal representatives. (as amended by Federal Law of 31.07.2020 N 271-FL)
3. Information on the state of health may not be provided to the patient against his will. In the event of an unfavourable prognosis of the development of the disease, the information must be communicated in a delicate form to the citizen or his spouse, one of the close relatives (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfathers, grandmothers), if the patient did not prohibit informing them of this and (or) did not determine another person to whom such information must be transferred.
4. The patient or his legal representative has the right to directly familiarize himself with the medical documentation reflecting the state of his health and to receive consultations from other specialists on the basis of such documentation. The spouse, close relatives (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfathers, grandmothers) or other persons specified by the patient or his legal representative in the written consent to the disclosure of information constituting medical secrecy or in the informed voluntary consent to medical intervention have the right to directly familiarize themselves with the medical documentation of the patient, including after his death, if the patient or his legal representative did not prohibit the disclosure of information constituting medical secrecy. The procedure for familiarization with the medical documentation of the patient is established by the authorized federal executive body. (as amended by Federal Law of 02.07.2021 N 315-FL)
5. The patient or his legal representative has the right, upon a request sent, among other ways, in electronic form, to receive medical documents (copies thereof) reflecting the state of health of the patient and extracts from them, including in the form of electronic documents. The spouse, close relatives (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfathers, grandmothers) or other persons specified by the patient or his legal representative in the written consent to the disclosure of information constituting medical secrecy or in the informed voluntary consent to medical intervention have the right to receive medical documents (copies thereof) and extracts from them, including after his death, if the patient or his legal representative did not prohibit the disclosure of information constituting medical secrecy. The procedure and terms for the provision of medical documents (copies thereof) and extracts from them are established by the authorized federal executive body. (as amended by Federal Laws of 29.07.2017 N 242-FL, of 02.07.2021 N 315-FL)

 

Article 23. Information on Factors Affecting Health

Citizens have the right to receive reliable and timely information on factors contributing to the preservation of health or having a harmful influence on it, including information on the sanitary and epidemiological well-being of the area of residence, the state of the habitat, rational nutrition norms, the quality and safety of products for industrial and technical purposes, food products, goods for personal and household needs, the potential danger to human health of the work performed and the services rendered. Such information is provided by bodies of state power and local self-government bodies in accordance with their powers, and also by organizations in the procedure provided for by the legislation of the Russian Federation.

 

Article 24. Rights to Health Protection of Workers Engaged in Certain Types of Work

1. For the purposes of the protection of health and the preservation of the ability to work, the prevention and timely detection of occupational diseases, workers engaged in work with harmful and (or) dangerous production factors, and also, in the cases provided for by the legislation of the Russian Federation, workers engaged in certain types of work, undergo mandatory medical examinations.
2. The list of harmful and (or) dangerous production factors and of work in the performance of which mandatory preliminary medical examinations upon entering employment and periodic medical examinations are conducted is approved by the authorized federal executive body.
3. In the event of the identification, during the conduct of mandatory medical examinations, of medical contraindications to the carrying out of certain types of work, the list of which is established by the authorized federal executive body, a worker may be recognized by the medical commission of a medical organization, on the basis of the results of an expert examination of occupational fitness, as temporarily or permanently unfit, due to his state of health, for the performance of certain types of work.
4. For the purposes of health protection, employers are entitled to introduce into the staff positions of medical workers and to create subdivisions (a physician’s office, a health post, a medical office, a medical unit and other subdivisions) providing medical care to the workers of the organization. The procedure for the organization of the activities of such subdivisions and medical workers is established by the authorized federal executive body.
5. Employers are obliged to ensure conditions for workers undergoing medical examinations and dispanserization, and also to release workers without hindrance for undergoing them.

 

Article 25. Rights to Health Protection of Military Servicemen and Persons Equated to Military Servicemen in Terms of Medical Support, and also of Citizens Undergoing Alternative Civilian Service, Citizens Subject to Conscription for Military Service (Being Sent to Alternative Civilian Service), and Citizens Entering Military Service or Service Equated to It under Contract

1. Military servicemen and persons equated to military servicemen in terms of medical support (hereinafter – military servicemen and persons equated to them), and also citizens undergoing alternative civilian service, have the right to undergo a military medical expert examination for the determination of fitness for military service or service equated to it and for early discharge from military service or service equated to it on the basis of the conclusion of a military medical commission.
2. Citizens subject to conscription for military service or being sent to alternative civilian service, and citizens entering military service or service equated to it under contract, undergo medical certification in the procedure provided for by Article 61 of this Federal Law, and have the right to receive complete information on medical contraindications for undergoing military service or service equated to it and on indications for deferment or exemption from conscription for military service due to the state of health.
3. Military servicemen and persons equated to them have the right to receive medical care in departmental medical organizations, and in their absence or in the absence in departmental medical organizations of departments of the relevant profile, specialists or special medical equipment – to receive medical care in the procedure established by the Government of the Russian Federation at the expense of the budget allocations of the federal budget provided for these purposes to federal executive bodies and federal state bodies in which a federal law provides for military service or service equated to it. (as amended by Federal Law of 04.06.2014 N 145-FL)
4. The procedure for the organization of medical care for military servicemen and persons equated to them is established by the Government of the Russian Federation; the specifics of the organization of the provision of medical care to military servicemen and persons equated to them, including the procedure for their release from the performance of the duties of military service (service duties) in connection with a disease and other reasons, are established by federal executive bodies and federal state bodies in which a federal law provides for military service or service equated to it. (as amended by Federal Law of 04.06.2014 N 145-FL)
5. Citizens, upon their registration for military records, conscription or entry into military service under contract or service equated to it, entry into military professional educational organizations or military educational organizations of higher education, conclusion with the Ministry of Defence of the Russian Federation of a contract on training in a military training centre at a federal state educational organization of higher education under a military training programme or in a military educational organization of higher education under a programme of military training of reserve sergeants, petty officers or a programme of military training of reserve soldiers, sailors, call-up for military training sessions, and also citizens being sent to alternative civilian service, have the right to receive medical care in medical organizations within the framework of the programme of state guarantees of the free provision of medical care to citizens, except for medical certification for the purposes of determining fitness for military service or service equated to it. (as amended by Federal Law of 03.08.2018 N 309-FL)
6. The specifics of the health protection of military servicemen and persons equated to them, and also of certain categories of citizens undergoing military service or service equated to it in federal executive bodies and federal state bodies in which a federal law provides for military service or service equated to it, are determined by the legislation of the Russian Federation regulating the activities of these bodies. (as amended by Federal Law of 04.06.2014 N 145-FL)

 

Article 26. Rights of Persons Detained, Taken into Custody, Serving a Punishment in the Form of Restriction of Liberty, Arrest, Deprivation of Liberty or Administrative Arrest to Receive Medical Care

1. Persons detained, taken into custody, serving a punishment in the form of restriction of liberty, arrest, deprivation of liberty or administrative arrest have the right to the provision of medical care, including, where necessary, in medical organizations of the state health care system and the municipal health care system, in accordance with the legislation of the Russian Federation.
2. Pregnant women, women during childbirth and in the postpartum period from among the persons specified in Part 1 of this Article have the right to the provision of medical care, including in medical organizations for the protection of motherhood and childhood.
3. If it is impossible to provide medical care in institutions of the penal enforcement system and (or) pre-trial detention centres of bodies of the federal security service, persons taken into custody or serving a punishment in the form of deprivation of liberty have the right to the provision of medical care in medical organizations of the state health care system and the municipal health care system, and also to the invitation of specialist physicians of the said medical organizations for consultations, in the procedure established by the Government of the Russian Federation, at the expense of the budget allocations of the federal budget provided for these purposes, respectively, to the federal executive body exercising law enforcement functions, functions of control and supervision in the sphere of the execution of criminal punishments in respect of convicts, and to the federal executive body in the field of ensuring security. (as amended by Federal Law of 23.07.2025 N 239-FL)
4. During the provision of medical care in medical organizations of the state health care system and the municipal health care system, officers of bodies and institutions of the penal enforcement system carry out the guarding of the persons specified in Part 3 of this Article and, where necessary, round-the-clock observation for the purposes of ensuring the safety of the said persons, medical workers, and also other persons present in medical organizations of the state and municipal health care systems, in the procedure established by the federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of the execution of criminal punishments jointly with the authorized federal executive body.

4.1. During the provision of medical care in medical organizations of the state health care system and the municipal health care system, officers of bodies of the federal security service carry out the guarding of persons taken into custody or serving a punishment in pre-trial detention centres of bodies of the federal security service and, where necessary, round-the-clock observation for the purposes of ensuring the safety of the said persons, medical workers, and also other persons present in medical organizations of the state and municipal health care systems, in the procedure established by the federal executive body in the field of ensuring security jointly with the authorized federal executive body.(as amended by Federal Law of 23.07.2025 N 239-FL)

5. Clinical approbation, testing of medicinal products, specialized therapeutic nutrition products, medical devices and disinfectants with the involvement of the persons specified in Part 1 of this Article as an object for these purposes are not permitted. (as amended by Federal Law of 08.03.2015 N 55-FL)
6. In respect of persons serving a punishment in institutions of the penal enforcement system and pre-trial detention centres of bodies of the federal security service, a voluntary medical insurance contract is terminated. (as amended by Federal Law of 23.07.2025 N 239-FL)
7. The procedure for the organization of the provision of medical care, including in medical organizations of the state and municipal health care systems, to the persons specified in Part 1 of this Article is established by the legislation of the Russian Federation, including, respectively, by normative legal acts of the authorized federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of the execution of criminal punishments, of the federal executive body in the field of ensuring security in agreement with the authorized federal executive body. (as amended by Federal Law of 23.07.2025 N 239-FL)

 

Article 27. Duties of Citizens in the Sphere of Health Protection

1. Citizens are obliged to take care of the preservation of their health.
2. Citizens, in the cases provided for by the legislation of the Russian Federation, are obliged to undergo medical examinations, and citizens suffering from diseases posing a danger to others, in the cases provided for by the legislation of the Russian Federation, are obliged to undergo medical examination and treatment, and also to engage in the prevention of these diseases.
3. Citizens undergoing treatment are obliged to observe the treatment regime, including that determined for the period of their temporary incapacity for work, and the rules of conduct of the patient in medical organizations.

 

Article 28. Public Associations for the Protection of the Rights of Citizens in the Sphere of Health Protection

1. Citizens have the right to create public associations for the protection of the rights of citizens in the sphere of health protection, formed on a voluntary basis.
2. Public associations for the protection of the rights of citizens in the sphere of health protection may, in the procedure established by the legislation of the Russian Federation, take part in the development of norms and rules in the sphere of health protection and in resolving matters related to the violation of such norms and rules.
3. Public associations for the protection of the rights of citizens in the sphere of health protection are not entitled to advertise specific trade names of medicinal products, biologically active additives, medical devices, specialized therapeutic nutrition products and breast milk substitutes.

 

Chapter 5. ORGANIZATION OF HEALTH PROTECTION

 

Article 29. Organization of Health Protection

1. The organization of health protection is carried out by means of:

1) state regulation in the sphere of health protection, including normative legal regulation;

2) the development and implementation of measures for the prevention of the occurrence and spread of diseases, including socially significant diseases and diseases posing a danger to others, and for the formation of a healthy lifestyle of the population;

3) the organization of the provision of first aid, of all types of medical care, including to citizens suffering from socially significant diseases, diseases posing a danger to others, rare (orphan) diseases;

4) the ensuring of the sanitary and epidemiological well-being of the population;

5) the provision of certain categories of citizens of the Russian Federation with medicinal products, medical devices and specialized therapeutic nutrition products in accordance with the legislation of the Russian Federation;

6) the management of activities in the sphere of health protection on the basis of state regulation, and also of self-regulation carried out in accordance with a federal law.

2. The organization of health protection is based on the functioning and development of the state, municipal and private health care systems.
3. The state health care system consists of:

1) federal executive bodies in the sphere of health protection and their territorial bodies; (as amended by Federal Law of 27.09.2013 N 253-FL)

2) executive bodies of constituent entities of the Russian Federation in the sphere of health protection, management bodies in the sphere of health protection of other federal executive bodies (except for the federal executive bodies specified in Clause 1 of this Part); (as amended by Federal Law of 08.08.2024 N 232-FL)

3) medical organizations and pharmaceutical organizations subordinate to federal executive bodies and executive bodies of constituent entities of the Russian Federation, health care organizations for ensuring supervision in the sphere of consumer rights protection and human well-being, forensic expert institutions, other organizations and their separate subdivisions carrying out activities in the sphere of health protection. (as amended by Federal Laws of 01.12.2014 N 418-FL, of 08.08.2024 N 232-FL)

4. The municipal health care system consists of:

1) local self-government bodies of municipal districts, municipal okrugs and urban okrugs exercising powers in the sphere of health protection; (as amended by Federal Law of 26.05.2021 N 152-FL)

2) medical organizations and pharmaceutical organizations subordinate to local self-government bodies.

5. The private health care system consists of medical organizations, pharmaceutical organizations and other organizations carrying out activities in the sphere of health protection created by legal entities and natural persons.

 

Article 29.1. Liquidation of Medical Organizations, Termination of the Activities of Separate Subdivisions of Medical Organizations (as amended by Federal Law of 29.12.2017 N 465-FL)

1. Medical organizations are liquidated in the procedure established by civil legislation, taking into account the specifics provided for by the legislation of the Russian Federation in the sphere of health protection.
2. In respect of a medical organization subordinate to an executive body of state power of a constituent entity of the Russian Federation or a local self-government body, the adoption of a decision on its liquidation, on the termination of the activities of its separate subdivision is carried out on the basis of a positive conclusion of the commission for the assessment of the consequences of the adoption of such decision, which is created by the executive body of the constituent entity of the Russian Federation and which includes, on a parity basis, representatives of the legislative body of the constituent entity of the Russian Federation, the executive body of the constituent entity of the Russian Federation, the representative body of the municipal formation in the territory of which the medical organization or its separate subdivision is located, the local self-government body exercising the powers of the founder of the medical organization, the medical professional non-commercial organizations specified in Part 3 of Article 76 of this Federal Law, and public associations for the protection of the rights of citizens in the sphere of health protection. The procedure for the conduct of the assessment of the consequences of the adoption of such decision, including the criteria of this assessment, and also the procedure for the creation of the commission for the assessment of the consequences of the adoption of such decision and the preparation of conclusions by it is established by the executive executive body of the constituent entity of the Russian Federation. (as amended by Federal Laws of 08.08.2024 N 232-FL, of 07.06.2025 N 150-FL)
3. In respect of the only medical organization subordinate to an executive body of a constituent entity of the Russian Federation located in a rural settlement, the adoption of a decision on its liquidation, on the termination of the activities of its separate subdivision is carried out in the procedure established by Part 2 of this Article, taking into account the opinion of the residents of this rural settlement expressed according to the results of public hearings, the conduct of which is organized by the executive body of the constituent entity of the Russian Federation exercising the powers of the founder of the said medical organization. The procedure for the conduct of the public hearings provided for by this Part and for the determination of their results is determined by the executive body of the constituent entity of the Russian Federation in accordance with Federal Law of 21 July 2014 N 212-FL “On the Fundamentals of Public Control in the Russian Federation”. (as amended by Federal Law of 08.08.2024 N 232-FL)
4. In respect of the only medical organization subordinate to a local self-government body located in a rural settlement, the adoption of a decision on its liquidation, on the termination of the activities of its separate subdivision is carried out in the procedure established by Part 2 of this Article, taking into account the opinion of the residents of this rural settlement expressed according to the results of public hearings, the conduct of which is organized by the local self-government body exercising the powers of the founder of the said medical organization. The procedure for the conduct of the public hearings provided for by this Part and for the determination of their results is determined by the local self-government body exercising the powers of the founder of the medical organization in accordance with Federal Law of 21 July 2014 N 212-FL “On the Fundamentals of Public Control in the Russian Federation”.

 

Article 30. Prevention of Diseases and Formation of a Healthy Lifestyle

1. The prevention of infectious diseases is carried out by bodies of state power, local self-government bodies, employers, medical organizations, public associations by means of the development and implementation of a system of legal, economic and social measures aimed at the prevention of the occurrence, the spread and the early detection of such diseases, including within the framework of the programme of state guarantees of the free provision of medical care to citizens, the programme of immunoprophylaxis of infectious diseases in accordance with the national calendar of preventive vaccinations and the calendar of preventive vaccinations according to epidemic indications.
2. The prevention of non-communicable diseases is carried out at the population, group and individual levels by bodies of state power, local self-government bodies, employers, medical organizations, educational organizations and physical culture and sports organizations, public associations by means of the development and implementation of a system of legal, economic and social measures aimed at the prevention of the occurrence, the spread and the early detection of such diseases, and also at the reduction of the risk of their development, the prevention and elimination of the negative influence on health of the factors of the internal and external environment, the formation of a healthy lifestyle.
3. The formation of a healthy lifestyle among citizens, beginning from childhood, is ensured by means of the conduct of measures aimed at informing citizens about the risk factors for their health, the formation of motivation to lead a healthy lifestyle and the creation of conditions for leading a healthy lifestyle, including for engaging in physical culture and sports.
4. The procedure for the organization and carrying out of the prevention of non-communicable diseases and the conduct of measures for the formation of a healthy lifestyle in medical organizations is established by the authorized federal executive body. (as amended by Federal Law of 25.11.2013 N 317-FL)

 

Article 31. First Aid

1. First aid is a set of measures aimed at the preservation and maintenance of the life and health of victims and carried out in the event of accidents, traumas, wounds, injuries, poisonings, other states and diseases threatening the life and health of victims, before the provision of medical care. First aid is provided by persons obliged to provide first aid in accordance with federal laws or other normative legal acts, including officers of internal affairs bodies of the Russian Federation, officers, military servicemen and workers of the State Fire Service, rescuers of emergency rescue formations and emergency rescue services, and also by the victims themselves (self-help) or by persons nearby (mutual help) in the cases provided for by federal laws. (as amended by Federal Law of 14.04.2023 N 135-FL)
2. First aid is provided in accordance with procedures approved by the authorized federal executive body, unless otherwise provided for by federal laws, and including: (as amended by Federal Law of 14.04.2023 N 135-FL)

1) the list of states in which first aid is provided; (as amended by Federal Law of 14.04.2023 N 135-FL)

2) the list of measures for the provision of first aid; (as amended by Federal Law of 14.04.2023 N 135-FL)

3) the sequence of the conduct of measures for the provision of first aid. (as amended by Federal Law of 14.04.2023 N 135-FL)

3. Model programmes of a training course, subject and discipline on the provision of first aid are developed by the authorized federal executive body and approved in the procedure established by the legislation of the Russian Federation, unless otherwise provided for by federal laws. (as amended by Federal Law of 11.06.2022 N 166-FL)

3.1. The list of states in which first aid is provided to military servicemen of the Armed Forces of the Russian Federation, other troops, military formations and bodies in wartime conditions, the conduct of military (combat) operations, the performance of combat (training and combat), service and combat (operational and service) tasks in the field of defence, the rules for its provision and the procedure for the organization of the training of military servicemen in the provision of first aid in wartime conditions, the conduct of military (combat) operations, the performance of combat (training and combat), service and combat (operational and service) tasks in the field of defence are determined by the legislation of the Russian Federation in the field of defence. (as amended by Federal Law of 11.06.2022 N 166-FL)

4. Drivers of vehicles and other persons are entitled to provide first aid if they have the appropriate training and (or) skills.
5. Requirements for the contents of packs, sets, kits and first-aid kits for the provision of first aid with the use of medical devices and (or) medicinal products are approved by the authorized federal executive body in agreement with the federal executive bodies exercising the functions of developing state policy and normative legal regulation in the relevant sphere, unless otherwise provided for by federal laws. Requirements for the placement, storage and use of packs, sets, kits and first-aid kits are approved by the federal executive bodies exercising the functions of developing state policy and normative legal regulation in the relevant sphere, in agreement with the authorized federal executive body. (as amended by Federal Law of 14.04.2023 N 135-FL)

 

Article 32. Medical Care

1. Medical care is provided by medical organizations and is classified by the types, conditions and form of the provision of such care.
2. The types of medical care include:

1) primary health care;

2) specialized, including high-tech, medical care;

3) emergency, including emergency specialized, medical care;

4) palliative medical care.

3. Medical care may be provided in the following conditions:

1) outside a medical organization (at the place of call of an emergency, including emergency specialized, medical care team, and also in a vehicle during medical evacuation);

2) on an outpatient basis (in conditions not providing for round-the-clock medical observation and treatment), including at home upon calling a medical worker;

3) in a day hospital (in conditions providing for medical observation and treatment in the daytime, but not requiring round-the-clock medical observation and treatment);

4) on an inpatient basis (in conditions ensuring round-the-clock medical observation and treatment).

4. The forms of the provision of medical care are:

1) emergency – medical care provided in sudden acute diseases, states, exacerbation of chronic diseases posing a threat to the life of the patient;

2) urgent – medical care provided in sudden acute diseases, states, exacerbation of chronic diseases without obvious signs of a threat to the life of the patient;

3) planned – medical care which is provided during the conduct of preventive measures, in diseases and states not accompanied by a threat to the life of the patient, not requiring emergency and urgent medical care, and the postponement of the provision of which for a certain time will not entail a deterioration of the state of the patient, a threat to his life and health.

5. Part has ceased to be in force. (as amended by Federal Law of 25.12.2018 N 489-FL)
6. Medical care is provided by medical workers in accordance with the procedures for the provision of medical care, the regulations on the organization of the provision of medical care. Other workers of a medical organization may participate in the provision of medical care if the possibility of their participation in the provision of medical care is provided for by labour (job) duties and by the said procedures for the provision of medical care, regulations on the organization of the provision of medical care. (as amended by Federal Law of 08.08.2024 N 290-FL)

 

Article 33. Primary Health Care

1. Primary health care is the basis of the system of the provision of medical care and includes measures for the prevention, diagnosis, treatment of diseases and states, medical rehabilitation, observation of the course of pregnancy, the formation of a healthy lifestyle and the sanitary and hygienic education of the population.
2. The organization of the provision of primary health care to citizens for the purposes of bringing it closer to their place of residence, place of work or study is carried out according to the territorial-district principle, providing for the formation of groups of the population served according to the place of residence, place of work or study in certain organizations, taking into account the provisions of Article 21 of this Federal Law.
3. Primary health care is subdivided into primary pre-medical health care, primary medical health care and primary specialized health care. (as amended by Federal Law of 08.08.2024 N 290-FL)

4-5. Parts have ceased to be in force. (as amended by Federal Law of 08.08.2024 N 290-FL)

6. Primary health care is provided on an outpatient basis and in day hospital conditions.
7. For the purposes of the provision to citizens of primary health care in sudden acute diseases, states, exacerbation of chronic diseases not accompanied by a threat to the life of the patient and not requiring emergency medical care, subdivisions of medical care providing the said care in urgent form may be created in the structure of medical organizations.

 

Article 34. Specialized, Including High-Tech, Medical Care

1. Specialized medical care includes the prevention, diagnosis and treatment of diseases and states (including during pregnancy, childbirth and the postpartum period) requiring the use of special methods and complex medical technologies, and also medical rehabilitation. (as amended by Federal Law of 08.08.2024 N 290-FL)
2. Specialized medical care is provided in inpatient conditions and in day hospital conditions.
3. High-tech medical care, which is part of specialized medical care, includes the application of new complex and (or) unique methods of treatment, and also of resource-intensive methods of treatment with scientifically proven effectiveness, including cellular technologies, robotic equipment, information technologies and methods of genetic engineering, developed on the basis of the achievements of medical science and related branches of science and technology. (as amended by Federal Law of 25.11.2013 N 317-FL)

The provisions of Part 4 of Article 34 were applied until 01.01.2015 (Part 8 Article 101).

4. Part has ceased to be in force.

The provisions of Parts 5 – 7 of Article 34 were applied until 01.01.2017 (Part 8.1 of Article 101).

5-7. Parts have ceased to be in force.

7.1. The procedure for the formation of the list of types of high-tech medical care, established by the authorized federal executive body, includes, among other things, the time limits upon the expiry of which types of high-tech medical care are included in the basic programme of compulsory medical insurance. (as amended by Federal Law of 03.07.2016 N 286-FL)

7.2. The list of medical organizations providing, at the expense of the budget allocations of the budgets of constituent entities of the Russian Federation, high-tech medical care not included in the basic programme of compulsory medical insurance is approved by the authorized executive body of a constituent entity of the Russian Federation. The procedure for the formation of the said list is established by the highest executive body of the constituent entity of the Russian Federation. (as amended by Federal Laws of 02.12.2019 N 399-FL, of 08.08.2024 N 232-FL)

8. The organization of the provision of high-tech medical care is carried out with the use of the unified state information system in the sphere of health care in the procedure established by the authorized federal executive body. (as amended by Federal Law of 29.07.2017 N 242-FL)

 

Article 35. Emergency, Including Emergency Specialized, Medical Care

1. Emergency, including emergency specialized, medical care is provided to citizens in diseases, accidents, traumas, poisonings and other states requiring urgent medical intervention. Emergency, including emergency specialized, medical care is provided to citizens by medical organizations of the state and municipal health care systems free of charge.
2. Emergency, including emergency specialized, medical care is provided in emergency or urgent form outside a medical organization, and also on an outpatient and inpatient basis.
3. In the territory of the Russian Federation, for the purposes of the provision of emergency medical care, a system of a single number for calling emergency medical care functions in the procedure established by the Government of the Russian Federation.
4. During the provision of emergency medical care, where necessary, medical evacuation is carried out, which is the transportation of citizens for the purposes of saving lives and preserving health (including persons undergoing treatment in medical organizations in which there is no possibility of providing the necessary medical care in life-threatening states, women during pregnancy, childbirth, the postpartum period and newborns, persons affected as a result of emergency situations and natural disasters).
5. Medical evacuation includes:

1) sanitary aviation evacuation carried out by aircraft; (as amended by Federal Law of 25.11.2013 N 317-FL)

2) sanitary evacuation carried out by land, water and other types of transport.

6. Medical evacuation is carried out by mobile emergency medical care teams with the conduct during transportation of measures for the provision of medical care, including with the use of medical equipment.
7. Medical organizations subordinate to federal executive bodies are entitled to carry out medical evacuation in the procedure and on the conditions established by the authorized federal executive body. The list of the said medical organizations subordinate to federal executive bodies is approved by the authorized federal executive body. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL)
8. Mobile emergency advisory teams of emergency medical care provide medical care (except for high-tech medical care), including upon the call of a medical organization whose staff does not include the medical workers of the mobile emergency advisory team of emergency medical care, in the event of the impossibility of providing the necessary medical care in the said medical organization.

 

Article 36. Palliative Medical Care (as amended by Federal Law of 06.03.2019 N 18-FL)

1. Palliative medical care is a set of measures including medical interventions, measures of a psychological nature and care, carried out for the purposes of improving the quality of life of incurably ill citizens and aimed at the relief of pain and other severe manifestations of the disease.
2. Palliative medical care is subdivided into palliative primary medical care, including pre-medical and medical, and palliative specialized medical care.
3. Palliative medical care is provided on an outpatient basis, including at home, and in day hospital conditions, in inpatient conditions by medical workers who have undergone training in the provision of such care. Medical organizations providing palliative medical care interact with relatives and other family members of the patient or the legal representative of the patient, persons caring for the patient, volunteers, and also with social service organizations, religious organizations, the organizations specified in Part 2 of Article 6 of this Federal Law, including for the purposes of providing such patient with social services, measures of social protection (support) in accordance with the legislation of the Russian Federation, measures of psychological support and spiritual assistance.
4. In the provision of palliative medical care, the patient is provided, for use at home, with medical devices intended for maintaining the functions of organs and systems of the human organism. The list of such medical devices is approved by the authorized federal executive body.
5. The regulations on the organization of the provision of palliative medical care, including the procedure for the interaction of medical organizations, social service organizations and the organizations specified in Part 2 of Article 6 of this Federal Law, are approved by the authorized federal executive body jointly with the federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of social protection of the population.

 

Article 36.1. Specifics of Medical Care Provided within the Framework of Clinical Approbation (as amended by Federal Law of 08.03.2015 N 55-FL)

1. Clinical approbation is the practical application of developed and previously not applied methods of prevention, diagnosis, treatment and rehabilitation in the provision of medical care for the confirmation of evidence of their effectiveness.
2. Medical care within the framework of clinical approbation is provided if there are conclusions of the ethics committee and the expert council of the authorized federal executive body. The regulations on the ethics committee and the expert council, their compositions and the procedure for the rendering by them of the relevant conclusions are approved by the authorized federal executive body.
3. The ethics committee renders a conclusion on the ethical justification of the possibility of applying the relevant methods of prevention, diagnosis, treatment and rehabilitation in the provision of medical care within the framework of clinical approbation and approves the protocol of clinical approbation.
4. The expert council gives permission for the provision of medical care within the framework of clinical approbation, which includes the determination of the number of patients to whom medical care will be provided within the framework of clinical approbation for each method of prevention, diagnosis, treatment and rehabilitation, and also determines the medical organizations participating in the provision of medical care within the framework of clinical approbation on the basis of the criteria for the selection of medical organizations established by the Government of the Russian Federation, gives an assessment of the financial costs of the provision of medical care under each protocol of clinical approbation and performs other functions provided for by the regulations on the expert council.
5. The regulations on the organization of clinical approbation and the provision of medical care within the framework of clinical approbation (including the procedure for the referral of patients for the provision of such medical care), the model form of the protocol of clinical approbation are approved by the authorized federal executive body.
6. Medical care within the framework of clinical approbation is provided if there is the informed voluntary consent of an adult legally capable patient, and in respect of a minor patient and a patient recognized as legally incapable in the procedure established by law – if there is the informed voluntary consent of one of the parents or another legal representative given in the procedure established by the authorized federal executive body.
7. The provision of medical care within the framework of clinical approbation is prohibited with the participation as patients of:

1) children, women during pregnancy, childbirth, women during breastfeeding, except for cases where the relevant methods are intended for these patients, provided that all necessary measures are taken to exclude the risk of causing harm to a woman during pregnancy, childbirth, a woman during breastfeeding, the foetus or the child;

2) military servicemen, except for military servicemen undergoing military service under contract, if the relevant methods have been specially developed for application in conditions of military operations, emergency situations, the prevention and treatment of diseases and injuries received as a result of the influence of adverse chemical, biological, radiation factors;

3) persons suffering from mental disorders, except for cases where the relevant methods are intended for the treatment of mental diseases.

8. The operation of the requirements established by Parts 2 – 5 of this Article in respect of medical care provided within the framework of clinical approbation with the use of medical devices created with the use of artificial intelligence technologies may be changed or excluded in respect of participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Law of 02.07.2021 N 331-FL)

 

Article 36.2. Specifics of Medical Care Provided with the Use of Telemedicine Technologies (as amended by Federal Law of 29.07.2017 N 242-FL)

1. Medical care with the use of telemedicine technologies is organized and provided in the procedure established by the authorized federal executive body, and also in accordance with the procedures for the provision of medical care and taking into account the standards of medical care. (as amended by Federal Law of 25.12.2018 N 489-FL)
2. Consultations of a patient or his legal representative by a medical worker with the use of telemedicine technologies are carried out for the purposes of:

1) prevention, the collection and analysis of the complaints of the patient and the data of the anamnesis, the assessment of the effectiveness of therapeutic and diagnostic measures, the medical observation of the state of health of the patient;

2) taking a decision on the necessity of conducting an in-person appointment (examination, consultation).

2.1. The operation of the requirements established by Part 2 of this Article may be changed or excluded in respect of medical organizations of the private health care system – participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. The financial support of the provision to citizens of medical care with the use of telemedicine technologies within the framework of an experimental legal regime may not be carried out at the expense of the funds of the budgets of the budget system of the Russian Federation, including at the expense of the funds of compulsory medical insurance. (as amended by Federal Law of 02.07.2021 N 331-FL)

3. During the conduct of consultations with the use of telemedicine technologies, the attending physician may correct previously prescribed treatment provided that he has established the diagnosis and prescribed the treatment at an in-person appointment (examination, consultation). The operation of these requirements may be changed or excluded in respect of medical organizations of the private health care system – participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Law of 02.07.2021 N 331-FL)
4. Remote observation of the state of health of a patient is prescribed by the attending physician after an in-person appointment (examination, consultation). Remote observation is carried out on the basis of data on the patient registered with the use of medical devices intended for monitoring the state of the human organism, and (or) on the basis of data entered into the unified state information system in the sphere of health care, or the state information system in the sphere of health care of a constituent entity of the Russian Federation, or a medical information system, or the information systems specified in Part 5 of Article 91 of this Federal Law. The operation of these requirements may be changed or excluded in respect of medical organizations of the private health care system – participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Law of 02.07.2021 N 331-FL)
5. The application of telemedicine technologies in the provision of medical care is carried out in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data, and in observance of medical secrecy.
6. For the purposes of the identification and authentication of the participants of remote interaction in the provision of medical care with the use of telemedicine technologies, the unified identification and authentication system is used. The operation of this requirement may be changed in respect of medical organizations of the private health care system – participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Law of 02.07.2021 N 331-FL)
7. The documenting of information on the provision of medical care to a patient with the use of telemedicine technologies, including the entry of data into his medical documentation, is carried out with the use of the enhanced qualified electronic signature of the medical worker.

 

Article 37. Organization of the Provision of Medical Care (as amended by Federal Law of 25.12.2018 N 489-FL)

1. Medical care, except for medical care provided within the framework of clinical approbation, is organized and provided:

1) in accordance with the regulations on the organization of the provision of medical care by types of medical care, which are approved by the authorized federal executive body;

2) in accordance with the procedures for the provision of medical care approved by the authorized federal executive body and mandatory for execution in the territory of the Russian Federation by all medical organizations;

3) on the basis of clinical guidelines;

4) taking into account the standards of medical care approved by the authorized federal executive body.

1.1. The transition of medical organizations to the provision of medical care on the basis of clinical guidelines developed and approved in accordance with Parts 3, 4, 6 – 9 and 11 of this Article is carried out in stages in the procedure established by the Government of the Russian Federation, but not later than 1 January 2025. (as amended by Federal Laws of 02.07.2021 N 315-FL, of 25.12.2023 N 625-FL)

2. The procedure for the provision of medical care is developed for its individual profiles, diseases or states (groups of diseases or states) and includes:

1) the stages of the provision of medical care;

2) the rules for the organization of the activities of the medical organization (its structural subdivision, physician);

3) the equipment standard of the medical organization, its structural subdivisions;

4) the recommended staffing standards of the medical organization, its structural subdivisions;

5) other provisions based on the specifics of the provision of medical care.

Medical professional non-commercial organizations develop and approve clinical guidelines on the list of diseases, states (groups of diseases, states) specified in Part 3 (as worded by Federal Law of 25.12.2018 N 489-FL) until 31.12.2021 (Clause 3 of Article 3 of Federal Law of 25.12.2018 N 489-FL).

3. Clinical guidelines are developed by medical professional non-commercial organizations for individual diseases or states (groups of diseases or states) with an indication of the medical services provided for by the nomenclature of medical services. The list of diseases, states (groups of diseases, states) for which clinical guidelines are developed is formed by the authorized federal executive body on the basis of the criteria established by it.
4. Clinical guidelines are subject to consideration by the scientific and practical council created by the authorized federal executive body. According to the results of the consideration, the scientific and practical council takes a decision on the approval, rejection or sending of the clinical guidelines for revision, after which it returns the said clinical guidelines to the medical professional non-commercial organization that submitted them, with the relevant decision attached.
5. The scientific and practical council includes representatives of scientific organizations, educational organizations of higher education, medical organizations subordinate to the authorized federal executive body. The regulations on the scientific and practical council and its composition are approved by the authorized federal executive body.
6. Clinical guidelines approved by the scientific and practical council are endorsed by medical professional non-commercial organizations.
7. For each disease, state (group of diseases, states), for adults and children, respectively, not more than one clinical guideline may be approved and endorsed.
8. In the event of receipt by the scientific and practical council of several clinical guidelines for one disease, state (group of diseases, states) from several medical professional non-commercial organizations, the scientific and practical council either takes a decision on the approval of one of the clinical guidelines received, or organizes work on the joint development, by the medical professional non-commercial organizations that sent the said clinical guidelines, of one clinical guideline.
9. The procedure and terms for the development of clinical guidelines, their revision, the procedure for the application of clinical guidelines, the model form of clinical guidelines and the requirements for their structure, the requirements for the composition and scientific validity of the information included in clinical guidelines, the procedure and terms for the approval and endorsement of clinical guidelines, the criteria for the scientific and practical council’s taking a decision on the approval, rejection or sending for revision of a clinical guideline or a decision on the revision of a clinical guideline are approved by the authorized federal executive body. (as amended by Federal Law of 23.07.2025 N 261-FL)
10. Clinical guidelines are revised at least once every three years.
11. In the event of the non-submission by medical professional non-commercial organizations of clinical guidelines for approval or revision within the established terms, the development of clinical guidelines is carried out by the scientific and practical council with the involvement of other medical professional non-commercial organizations having medical workers in the relevant specialty among their members.
12. Medical professional non-commercial organizations have the right to develop clinical guidelines for diseases, states (groups of diseases, states) not included in the list of diseases, states (groups of diseases, states) provided for by Part 3 of this Article. Such clinical guidelines are subject to approval and endorsement in the procedure established by this Article.
13. Clinical guidelines approved by the scientific and practical council and endorsed by medical professional non-commercial organizations are placed on the official website of the authorized federal executive body in the “Internet” network.
14. A standard of medical care is developed on the basis of clinical guidelines approved and endorsed in accordance with this Article, in the procedure established by the authorized federal executive body, and includes averaged indicators of the frequency of provision and the multiplicity of application of:

1) medical services included in the nomenclature of medical services;

2) medicinal products registered in the territory of the Russian Federation (with an indication of average doses) in accordance with the instructions for the use of the medicinal product and the pharmacotherapeutic group according to the anatomical therapeutic chemical classification recommended by the World Health Organization;

3) medical devices implanted into the human organism;

4) blood components;

5) types of therapeutic nutrition, including specialized therapeutic nutrition products;

6) other items based on the specifics of the disease (state).

14.1. The inclusion in the standards of medical care for children and in clinical guidelines of a medicinal product registered in the territory of the Russian Federation, applied in accordance with indicators (characteristics) of the medicinal product not specified in the instructions for its use, is permitted if such medicinal product conforms to the requirements established by the Government of the Russian Federation. The list of diseases or states (groups of diseases or states) in which the application of a medicinal product in accordance with indicators (characteristics) of the medicinal product not specified in the instructions for its use is permitted is established by the Government of the Russian Federation. (as amended by Federal Law of 30.12.2021 N 482-FL)

15. The prescription and application of medicinal products, medical devices and specialized therapeutic nutrition products not included in the relevant standard of medical care or not provided for by the relevant clinical guideline are permitted in the presence of medical indications (individual intolerance, on vital indications) by decision of the medical commission. The operation of this requirement may be changed in respect of medical organizations of the private health care system – participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”. (as amended by Federal Law of 02.07.2021 N 331-FL)
16. For the purposes of the uniform application of the procedures for the provision of medical care, clinical guidelines and standards of medical care, the authorized federal executive body may, where necessary, issue relevant clarifications.
17. In the provision of medical care to citizens, the prescription to them by medical workers, in the procedure established by the authorized federal executive body in agreement with the federal executive body authorized to develop and approve state sanitary and epidemiological rules and hygienic standards, of registered biologically active additives included in the list of biologically active additives and meeting the criteria of the quality of biologically active additives and their effectiveness depending on the degree of influence on human health established by the Government of the Russian Federation, and also the requirements of the technical regulations of the Eurasian Economic Union, is permitted. (as amended by Federal Law of 07.06.2025 N 150-FL)

 

Article 38. Medical Devices

1. Medical devices are any instruments, apparatus, appliances, equipment, materials and other articles applied for medical purposes separately or in combination with each other, and also together with other accessories necessary for the application of the said articles as intended, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, the monitoring of the state of the human organism, the conduct of medical research, the restoration, replacement, change of the anatomical structure or physiological functions of the organism, the prevention or termination of pregnancy, the functional purpose of which is not realized by means of pharmacological, immunological, genetic or metabolic influence on the human organism. Medical devices may be recognized as interchangeable if they are comparable in functional purpose, qualitative and technical characteristics and are capable of replacing each other.
2. Medical devices are subdivided into classes depending on the potential risk of their application and into types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.
3. The circulation of medical devices includes technical tests, toxicological studies, clinical trials, the expert examination of the quality, effectiveness and safety of medical devices, their state registration, production, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, storage, transportation, sale, installation, adjustment, application, operation, including technical maintenance provided for by the normative, technical and (or) operational documentation of the manufacturer (maker), and also repair, recycling or destruction. The manufacturer (maker) of a medical device develops technical and (or) operational documentation in accordance with which the production, manufacture, storage, transportation, installation, adjustment, application, operation, including technical maintenance, and also repair, recycling or destruction of the medical device are carried out. Requirements for the content of the technical and operational documentation of the manufacturer (maker) of a medical device are established by the authorized federal executive body. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 11.06.2021 N 170-FL)

3.1. The transportation, installation, adjustment, setting up, calibration of a medical device and other actions necessary for putting the medical device into operation, the application, operation, including technical maintenance, and repair of the medical device provided for by the normative, technical and (or) operational documentation of the manufacturer (maker) are permitted after the expiry of the term of validity of the registration certificate for this medical device, if the service life (shelf life) of the medical device has not expired. (as amended by Federal Law of 30.04.2021 N 128-FL)

3.2. Until the expiry of the service life (shelf life) of medical devices, the circulation of such devices is permitted, including those produced within one hundred and eighty calendar days after the day of the adoption by the authorized federal executive body of a decision on introducing changes into the documents contained in the registration dossier for the medical device, in accordance with the information contained in such documents before the day of the adoption of the said decision. (as amended by Federal Law of 30.04.2021 N 128-FL)

3.3. The operation of the requirements established by Part 3 of this Article may be changed in respect of participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”, taking into account the requirements established by the law of the Eurasian Economic Union. (as amended by Federal Law of 02.07.2021 N 331-FL)

The provisions of Part 4 of Article 38 in the part of the approval of the procedure for the state registration of medical devices apply from 01.07.2012 (Article 101).

4. In the territory of the Russian Federation, the circulation of medical devices that have undergone state registration in the procedure established by the Government of the Russian Federation and of medical devices that have undergone registration in accordance with international treaties and acts constituting the law of the Eurasian Economic Union is permitted. The operation of these requirements may be changed in respect of participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”, taking into account the requirements established by the law of the Eurasian Economic Union. (as amended by Federal Laws of 30.04.2021 N 128-FL, of 02.07.2021 N 331-FL)
5. The following are not registered in the territory of the Russian Federation: (as amended by Federal Law of 30.04.2021 N 128-FL)

1) medical devices listed in Clause 11 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Framework of the Eurasian Economic Union of 23 December 2014; (as amended by Federal Law of 30.04.2021 N 128-FL)

The provisions of Clause 2 of Part 5 of Article 38 are in force up to and including 01.01.2027 (Clause 3 of Article 4 of Federal Law of 30.04.2021 N 128-FL).

2) medical devices imported into the territory of the Russian Federation for the provision of medical care on the vital indications of a specific patient on the basis of a permit issued, in the procedure established by the Government of the Russian Federation, by the authorized federal executive body exercising the functions of control and supervision in the sphere of health protection; (as amended by Federal Law of 30.04.2021 N 128-FL)

The provisions of Clause 3 of Part 5 of Article 38 are in force up to and including 01.01.2027 (Clause 3 of Article 4 of Federal Law of 30.04.2021 N 128-FL).

3) medical devices produced in the Russian Federation for export outside the territory of the Eurasian Economic Union and not intended for application in the territory of the Eurasian Economic Union, and also produced in the Russian Federation for the conduct of research and development work, studies (tests); (as amended by Federal Law of 30.04.2021 N 128-FL)

4) medical devices which are intended for application in the territory of the international medical cluster or in the territories of innovation scientific and technological centres; (as amended by Federal Law of 30.04.2021 N 128-FL)

The provisions of Clause 5 of Part 5 of Article 38 is in force up to and including 01.01.2027 (Clause 3 of Article 4 of Federal Law of 30.04.2021 N 128-FL).

5) medical devices constituting packs, sets, kits and first-aid kits consisting of registered medical devices (except for medical devices associated with a power source or equipped with a power source) and (or) medicinal products combined in common packaging, provided that the secondary (consumer) packaging, or the primary packaging of the medicinal product if secondary (consumer) packaging is not provided for, of the manufacturer (maker) of each of the devices and (or) medicinal products included in the said packs, sets, kits and first-aid kits is preserved, and provided that its labelling is preserved; (as amended by Federal Law of 30.04.2021 N 128-FL)

Clause 6 of Part 5 of Article 38 is in force from 01.01.2022 (Clause 2 of Article 4 of Federal Law of 30.04.2021 N 128-FL).

6) medical devices which are intended for the diagnosis of diseases by means of conducting studies of samples of human biological material outside the human organism, are manufactured in a medical organization and are applied in the medical organization that manufactured them (hereinafter – unregistered medical devices for in vitro diagnostics). (as amended by Federal Law of 30.04.2021 N 128-FL)

5.1. The specifics of the circulation, including the specifics of the state registration, of medical devices which are intended for application in conditions of military operations, emergency situations, the prevention of emergency situations, the prevention and treatment of diseases posing a danger to others, diseases and injuries received as a result of the influence of adverse chemical, biological, radiation factors, and which have been developed, among other things, on the instructions of federal executive bodies and federal state bodies in which a federal law provides for military service or service equated to it, and also of medical devices in the event of their shortage or the risk of the occurrence of a shortage in connection with the introduction of restrictive measures of an economic nature in respect of the Russian Federation, are established by the Government of the Russian Federation. (as amended by Federal Laws of 01.04.2020 N 98-FL, of 08.03.2022 N 46-FL)

5.2. The requirements for the content of the technical and operational documentation of the manufacturer (maker) established by the authorized federal executive body in accordance with Part 3 of this Article do not extend to the medical devices specified in Part 5 of this Article. (as amended by Federal Law of 30.04.2021 N 128-FL)

6. The procedure for the import into the territory of the Russian Federation of medical devices for the purposes of state registration is established by the authorized federal executive body. The procedure for the import into the territory of the Russian Federation of the medical devices specified in Clauses 1, 2 and 5 of Part 5 of this Article (except for the medical devices specified in subclauses “а”, “в” and “г” of Clause 11 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Framework of the Eurasian Economic Union of 23 December 2014) is established by the Government of the Russian Federation. (as amended by Federal Law of 30.04.2021 N 128-FL)
7. The import into the territory of the Russian Federation and the export from the territory of the Russian Federation of medical devices within the framework of doping control are carried out in the procedure established by the Government of the Russian Federation.
8. For the purposes of the state registration of medical devices, in the procedure established by the authorized federal executive body, an assessment of conformity in the form of technical tests, toxicological studies, clinical trials and an expert examination of the quality, effectiveness and safety of medical devices are conducted, and also tests for the purposes of the approval of the type of measuring instruments (in respect of medical devices related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the authorized federal executive body). The operation of these requirements may be changed in respect of participants of an experimental legal regime in the sphere of digital innovations in accordance with a programme of an experimental legal regime in the sphere of digital innovations approved in accordance with Federal Law of 31 July 2020 N 258-FL “On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation”, taking into account the requirements established by the law of the Eurasian Economic Union. (as amended by Federal Law of 02.07.2021 N 331-FL)

The production of medical devices in the DPR, LPR, Zaporozhye and Kherson Oblasts until 01.01.2025 is carried out without taking into account the requirements established by Part 8.1 of Article 38 (Clause 15 of Article 4 of Federal Law of 17.02.2023 N 16-FL).

8.1. The production of medical devices subject to state registration, and also of medical devices which are manufactured according to individual orders of patients, to which special requirements are imposed on the prescription of medical workers, must conform to the requirements for the introduction, maintenance and assessment of the quality management system of medical devices depending on the potential risk of their application approved by the Government of the Russian Federation. The procedure for the organization and conduct of the inspection of the production of medical devices for conformity to the said requirements is established by the Government of the Russian Federation. The methodology for determining the amount of the fee for the conduct of such inspection is approved by the authorized federal executive body. (as amended by Federal Law of 30.04.2021 N 128-FL)

9. For the performance by the authorized federal executive body of actions related to the carrying out of the state registration of medical devices and the registration of medical devices in accordance with international treaties and acts constituting the law of the Eurasian Economic Union, a state duty is charged in accordance with the legislation of the Russian Federation on taxes and fees. (as amended by Federal Law of 30.04.2021 N 128-FL)
10. In the procedure established by the Government of the Russian Federation, the federal executive body authorized by it maintains the state register of medical devices and organizations (individual entrepreneurs) carrying out the production and manufacture of medical devices and places it on its official website in the “Internet” network. (as amended by Federal Law of 25.11.2013 N 317-FL)
11. The following data are entered into the state register of medical devices and organizations (individual entrepreneurs) carrying out the production and manufacture of medical devices: (as amended by Federal Law of 25.11.2013 N 317-FL)

1) the name of the medical device;

2) the date of the state registration of the medical device and its registration number, the term of validity of the registration certificate;

3) the purpose of the medical device established by the manufacturer;

4) the type of the medical device;

5) the class of potential risk of the application of the medical device;

6) the code of the All-Russian Classifier of Products by Types of Economic Activity; (as amended by Federal Law of 30.04.2021 N 128-FL)

7) the name and location of the legal entity – authorized representative of the manufacturer (maker) of the medical device, or the surname, name and (if any) patronymic, place of residence of the individual entrepreneur – authorized representative of the manufacturer (maker) of the medical device; (as amended by Federal Law of 30.04.2021 N 128-FL)

8) the name and location of the organization – manufacturer (maker) of the medical device, or the surname, name and (if any) patronymic, place of residence of the individual entrepreneur – manufacturer (maker) of the medical device; (as amended by Federal Law of 25.11.2013 N 317-FL)

9) the address of the place of production or manufacture of the medical device;

10) data on interchangeable medical devices;

11) other data determined by the Government of the Russian Federation. (as amended by Federal Law of 30.04.2021 N 128-FL)

11.1. In the territory of the Russian Federation, the manufacture, storage, application, recycling or destruction, in the procedure established by the authorized federal executive body, of unregistered medical devices for in vitro diagnostics are permitted if the medical organization has a permit for the application of such medical device granted by the authorized federal executive body exercising the functions of control and supervision in the sphere of health protection. The procedure for the granting, re-execution, confirmation and cancellation of a permit for the application of an unregistered medical device for in vitro diagnostics, and also the requirements for medical organizations in which unregistered medical devices for in vitro diagnostics are manufactured and applied, and the requirements for such medical devices are approved by the Government of the Russian Federation. For the granting, re-execution and confirmation of a permit for the application of an unregistered medical device for in vitro diagnostics, and also for the conduct of an expert examination of the quality, safety and effectiveness of an unregistered medical device for in vitro diagnostics for the purposes of granting a permit for the application of an unregistered medical device for in vitro diagnostics or confirming the said permit, a state duty is charged in accordance with the legislation of the Russian Federation on taxes and fees. (as amended by Federal Law of 30.04.2021 N 128-FL)

12. A falsified medical device is a medical device accompanied by false information on its characteristics and (or) manufacturer (maker). (as amended by Federal Law of 31.12.2014 N 532-FL)
13. A substandard medical device is a medical device which does not conform to the requirements for the safety and effectiveness of medical devices, the requirements for their labelling, the normative, technical and operational documentation and which cannot be safely used for the purpose established by the manufacturer (maker). (as amended by Federal Law of 30.04.2021 N 128-FL)
14. A counterfeit medical device is a medical device which is in circulation in violation of civil legislation. (as amended by Federal Law of 31.12.2014 N 532-FL)
15. The production of the following is prohibited: (as amended by Federal Law of 31.12.2014 N 532-FL)

1) unregistered medical devices, except for the medical devices specified in Part 5 of this Article; (as amended by Federal Law of 30.04.2021 N 128-FL)

2) falsified medical devices; (as amended by Federal Law of 31.12.2014 N 532-FL)

3) medical devices containing ethyl alcohol, at the place of the production of the pharmaceutical substance ethyl alcohol (ethanol) and (or) at the place of the production of ethyl alcohol; (as amended by Federal Law of 27.12.2019 N 481-FL)

4) medical devices containing ethyl alcohol, on the main technological equipment for the production of ethyl alcohol specified in Clause 1.1 of Article 14.1 of Federal Law of 22 November 1995 N 171-FL “On State Regulation of the Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products and on Limiting the Consumption (Drinking) of Alcoholic Products”. (as amended by Federal Law of 27.12.2019 N 481-FL)

15.1. In the event of the necessity to use ethyl alcohol, including the pharmaceutical substance ethyl alcohol (ethanol), in the production of medical devices containing ethyl alcohol, as an active and (or) auxiliary substance, and also for other technological purposes, only the pharmaceutical substance ethyl alcohol (ethanol) must be used. (as amended by Federal Law of 27.12.2019 N 481-FL)

16. The import into the territory of the Russian Federation of falsified medical devices, substandard medical devices and counterfeit medical devices, and also of unregistered medical devices, except for the medical devices specified in Part 5 of this Article, is prohibited. (as amended by Federal Laws of 31.12.2014 N 532-FL, of 30.04.2021 N 128-FL)
17. The sale of falsified medical devices, substandard medical devices and counterfeit medical devices, and also of unregistered medical devices, except for the medical devices specified in Part 5 of this Article, is prohibited. (as amended by Federal Laws of 31.12.2014 N 532-FL, of 30.04.2021 N 128-FL)
18. Falsified medical devices and substandard medical devices are subject to seizure and subsequent destruction or export from the territory of the Russian Federation, and counterfeit medical devices – to seizure and subsequent destruction. The export from the territory of the Russian Federation of falsified medical devices and substandard medical devices is carried out at the expense of the person who carried out their import into the territory of the Russian Federation. (as amended by Federal Law of 31.12.2014 N 532-FL)
19. Falsified medical devices and substandard medical devices are subject to withdrawal from circulation and destruction on the basis of a decision of the owner of the medical devices, a decision of the authorized federal executive body exercising the functions of control and supervision in the sphere of health protection, or a court decision. Counterfeit medical devices are subject to withdrawal from circulation and destruction by court decision. The procedure for the withdrawal from circulation and destruction of falsified medical devices, substandard medical devices and counterfeit medical devices is established by the Government of the Russian Federation. (as amended by Federal Law of 02.07.2021 N 314-FL)
20. The expenses related to the withdrawal from circulation and destruction of falsified medical devices, substandard medical devices and counterfeit medical devices are reimbursed by their owner. (as amended by Federal Laws of 31.12.2014 N 532-FL, of 02.07.2021 N 314-FL)
21. In conditions of an emergency situation and (or) upon the occurrence of a threat of the spread of a disease posing a danger to others, and also in the event that, within thirty calendar days after the adoption by the Government of the Russian Federation of a decision on the conduct of monitoring of retail prices for medical devices in the territories of constituent entities of the Russian Federation, a growth of retail prices for medical devices by thirty percent or more is identified, the Government of the Russian Federation is entitled to establish maximum selling prices of manufacturers for medical devices, maximum amounts of wholesale mark-ups and maximum amounts of retail mark-ups to the actual selling prices of manufacturers for medical devices. The list of medical devices and the procedure for its formation are determined by the Government of the Russian Federation. (as amended by Federal Law of 26.03.2020 N 67-FL)
22. Within ninety calendar days from the day of the approval by the Government of the Russian Federation of the list of medical devices specified in Part 21 of this Article, the sale and dispensing of the medical devices included in it at prices exceeding the maximum selling prices of manufacturers for the said medical devices, the maximum amounts of wholesale mark-ups and the maximum amounts of retail mark-ups to the actual selling prices of manufacturers, taking into account value added tax, are not permitted. (as amended by Federal Law of 26.03.2020 N 67-FL)
23. In conditions of an emergency situation and (or) upon the occurrence of a threat of the spread of a disease posing a danger to others, the Government of the Russian Federation is entitled to take a decision on the establishment of restrictions on the carrying out of wholesale and retail trade in medical devices included in a list determined by the Government of the Russian Federation for a term not exceeding ninety calendar days from the day of the adoption of the said decision. (as amended by Federal Law of 01.04.2020 N 98-FL)
24. In conditions of the introduction of restrictive measures of an economic nature in respect of the Russian Federation, the Government of the Russian Federation is entitled to take a decision on the establishment of restrictions on the export from the Russian Federation of medical devices previously imported into the Russian Federation from the territories of foreign states that have taken a decision on the introduction of restrictive measures of an economic nature in respect of the Russian Federation. (as amended by Federal Law of 08.03.2022 N 46-FL)
25. Manufacturers of medical devices or organizations carrying out the import of medical devices into the territory of the Russian Federation, not less than six months before the planned suspension or termination of the production of medical devices or of their import into the territory of the Russian Federation, notify thereof the federal executive body exercising the functions of control and supervision in the sphere of health care. (as amended by Federal Law of 26.03.2022 N 64-FL)

 

Article 39. Therapeutic Nutrition

1. Therapeutic nutrition is nutrition ensuring the satisfaction of the physiological needs of the human organism for nutrients and energy taking into account the mechanisms of the development of the disease, the specifics of the course of the underlying and concomitant diseases, and performing preventive and therapeutic tasks.
2. Therapeutic nutrition is an integral component of the therapeutic process and preventive measures, and includes food rations which have an established chemical composition, energy value, consist of certain products, including specialized therapeutic nutrition products, subjected to appropriate technological processing.
3. Specialized therapeutic nutrition products are food products with an established chemical composition, energy value and physical properties, a proven therapeutic effect, which have a specific influence on the restoration of the functions of the organism impaired or lost as a result of a disease, the prevention of these impairments, and also on the increase of the adaptive capabilities of the organism.
4. Norms of therapeutic nutrition are approved by the authorized federal executive body.

 

Article 40. Medical Rehabilitation and Sanatorium and Resort Treatment

1. Medical rehabilitation is a set of measures of a medical and psychological nature aimed at the full or partial restoration of impaired and (or) the compensation of lost functions of an affected organ or system of the organism, the maintenance of the functions of the organism in the process of the completion of an acutely developed pathological process or the exacerbation of a chronic pathological process in the organism, and also at the prevention, early diagnosis and correction of possible impairments of the functions of damaged organs or systems of the organism, the prevention and reduction of the degree of possible disability, the improvement of the quality of life, the preservation of the working capacity of the patient and his social integration into society.
2. Medical rehabilitation is carried out in medical organizations and includes the complex application of natural healing factors, drug and non-drug therapy and other methods.
3. Sanatorium and resort treatment includes medical care carried out by medical organizations (sanatorium and resort organizations) for preventive, therapeutic and rehabilitation purposes on the basis of the use of natural healing resources, including in conditions of stay in therapeutic and health-improving localities and at resorts. (as amended by Federal Law of 25.11.2013 N 317-FL)
4. Sanatorium and resort treatment is aimed at:

1) the activation of the protective-adaptive reactions of the organism for the purposes of the prevention of diseases, health improvement;

2) the restoration and (or) compensation of the functions of the organism impaired as a result of traumas, operations and chronic diseases, the reduction of the number of exacerbations, the extension of the period of remission, the slowing down of the development of diseases and the prevention of disability as one of the stages of medical rehabilitation.

5. The procedure for the organization of medical rehabilitation and sanatorium and resort treatment, the list of medical indications and contraindications for medical rehabilitation and sanatorium and resort treatment are approved by the authorized federal executive body.

 

Article 41. Organization and Provision of Medical Care in Emergency Situations

1. The organization and provision of medical care in emergency situations, including medical evacuation, are carried out by the All-Russian Disaster Medicine Service in the procedure established by the authorized federal executive body.
2. The All-Russian Disaster Medicine Service is a functional subsystem of the Unified State System for the Prevention and Elimination of Emergency Situations, functionally uniting the disaster medicine services of federal executive bodies, the forces and means of various federal executive bodies, executive bodies of constituent entities of the Russian Federation, local self-government bodies and organizations whose powers include the resolution of matters in the field of the protection of the population and territories from emergency situations, the elimination of the medical and sanitary consequences of emergency situations and the resolution of the problems of disaster medicine. (as amended by Federal Law of 08.08.2024 N 232-FL)
3. The All-Russian Disaster Medicine Service carries out the resolution of tasks of rapid response, mobilization of material and technical means and personnel in emergency situations for the purposes of saving the lives and preserving the health of the largest number of people by providing them with all types of medical care in a timely manner and in full, the elimination of epidemic foci, and also of the creation of a reserve of material stocks and training in the provision of medical care to citizens, including medical evacuation, in emergency situations.
4. The All-Russian Disaster Medicine Service is managed by the head of the authorized federal executive body.
5. The regulations on the All-Russian Disaster Medicine Service are approved by the Government of the Russian Federation.
6. The head of the All-Russian Disaster Medicine Service is entitled to take a decision on medical evacuation in emergency situations.

 

Article 42. Specifics of the Organization of the Provision of Medical Care to Certain Categories of Citizens (as amended by Federal Law of 22.10.2014 N 314-FL)

1. The specifics of the organization of the provision of medical care, including the provision of additional types and scopes of medical care provided for by the legislation of the Russian Federation, to the population of closed administrative-territorial formations, of territories with physical, chemical and biological factors dangerous to human health included in the relevant list, to workers of organizations included in the list of organizations of certain industries with especially dangerous working conditions, and also the specifics of the financial support of the provision of medical care to them, are established by the Government of the Russian Federation. (as amended by Federal Law of 25.11.2013 N 317-FL)
2. The list of closed administrative-territorial formations, territories with physical, chemical and biological factors dangerous to human health and the list of organizations of certain industries with especially dangerous working conditions are approved by the Government of the Russian Federation.
3. The specifics of the organization of the provision of medical care to persons holding state positions of the Russian Federation, persons filling certain positions of the federal state civil service, and other persons are established by acts of the President of the Russian Federation and acts of the Government of the Russian Federation. (as amended by Federal Law of 22.10.2014 N 314-FL)

 

Article 42.1. Medical and Biological Support of Athletes of the National Sports Teams of the Russian Federation, the Sports Teams of Constituent Entities of the Russian Federation and the Sports Teams of the Federal Territory “Sirius” (as amended by Federal Laws of 05.12.2017 N 373-FL, of 07.04.2025 N 65-FL)

1. The medical and biological support of athletes of the national sports teams of the Russian Federation, the sports teams of constituent entities of the Russian Federation and the sports teams of the federal territory “Sirius” is a set of measures aimed at the restoration of the working capacity and health of athletes, including medical interventions, measures of a psychological nature, systematic control of the state of health of athletes, the provision of athletes with medicinal products, medical devices and specialized food products, the conduct of scientific research in the field of sports medicine, and carried out in accordance with the requirements on the prevention of doping in sport and the combating of it established by the legislation on physical culture and sport, the World Anti-Doping Code, the anti-doping rules approved by international anti-doping organizations, and the all-Russian anti-doping rules developed taking into account the said code and rules, approved by the all-Russian anti-doping organization in the procedure established by the federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of physical culture and sport, and also of the provision of state services (including the prevention of doping in sport and the combating of it) and the management of state property in the sphere of physical culture and sport (hereinafter – the federal executive body in the field of physical culture and sport), in agreement with it. (as amended by Federal Laws of 28.04.2023 N 174-FL, of 07.04.2025 N 65-FL )
2. The procedure for the organization of the medical and biological support of athletes of the national sports teams of the Russian Federation is approved by the federal executive body exercising powers for the organization of the medical and biological support of athletes of the national sports teams of the Russian Federation, in agreement with the federal executive body in the field of physical culture and sport. (as amended by Federal Law of 28.04.2023 N 174-FL)
3. The procedure for the organization of the medical and biological support of athletes of the sports teams of constituent entities of the Russian Federation is approved, in accordance with the methodological guidelines provided for by Clause 13 of Part 1 of Article 14 of this Federal Law approved by the federal executive body exercising powers for the organization of the medical and biological support of athletes of the national sports teams of the Russian Federation, by the body of state power of the constituent entity of the Russian Federation in the sphere of health care in agreement with the body of state power of the constituent entity of the Russian Federation in the field of physical culture and sport. (as amended by Federal Law of 29.12.2025 N 550-FL)
4. The procedure for the organization of the medical and biological support of athletes of the sports teams of the federal territory “Sirius” is approved by the authorized body of public power of the federal territory “Sirius”. (as amended by Federal Law of 28.04.2023 N 174-FL, of 07.04.2025 N 65-FL )

 

Article 43. Medical Care for Citizens Suffering from Socially Significant Diseases and Citizens Suffering from Diseases Posing a Danger to Others

1. Citizens suffering from socially significant diseases and citizens suffering from diseases posing a danger to others are provided with medical care and dispensary observation is ensured in the relevant medical organizations.
2. The list of socially significant diseases and the list of diseases posing a danger to others are approved by the Government of the Russian Federation based on the high level of primary disability and mortality of the population, the reduction of the life expectancy of the sick.

2.1. For the purposes of the organization of the provision of medical care, including the provision of medicinal products for medical use, in certain diseases specified in Part 1 of this Article, the authorized federal executive body, in the procedure established by the Government of the Russian Federation, maintains the Federal Register of Persons Infected with the Human Immunodeficiency Virus and the Federal Register of Persons Suffering from Tuberculosis, containing the following data: (as amended by Federal Law of 03.07.2016 N 286-FL)

1) the insurance number of the individual personal account of the citizen in the system of compulsory pension insurance (if any); (as amended by Federal Law of 03.07.2016 N 286-FL)

2) the surname, name, patronymic, and also the surname which the citizen had at birth; (as amended by Federal Law of 03.07.2016 N 286-FL)

3) the date of birth; (as amended by Federal Law of 03.07.2016 N 286-FL)

4) sex; (as amended by Federal Law of 03.07.2016 N 286-FL)

5) the address of the place of residence; (as amended by Federal Law of 03.07.2016 N 286-FL)

6) the series and number of the passport (birth certificate) or another identity document, the date of issue of the said documents; (as amended by Federal Law of 03.07.2016 N 286-FL)

7) the date of inclusion in the relevant Federal Register; (as amended by Federal Law of 03.07.2016 N 286-FL)

8) the diagnosis of the disease (state); (as amended by Federal Law of 03.07.2016 N 286-FL)

9) other data determined by the Government of the Russian Federation. (as amended by Federal Law of 03.07.2016 N 286-FL)

2.2. Bodies of state power of constituent entities of the Russian Federation maintain the regional segments of the federal registers specified in Part 2.1 of this Article and ensure the timely submission of the data contained in them to the authorized federal executive body in the procedure established by the Government of the Russian Federation. (as amended by Federal Law of 03.07.2016 N 286-FL)

3. The specifics of the organization of the provision of medical care in certain diseases specified in Part 1 of this Article may be established by separate federal laws.
4. The specifics of the organization of the provision of medical care in the event of a threat of the spread of diseases posing a danger to others, and also the procedure for the collection and recording of information on the spread of diseases posing a danger to others and the composition of such information (including on persons to whom medical care is provided and other persons) are established by the Government of the Russian Federation. (as amended by Federal Law of 08.06.2020 N 166-FL)

 

Article 44. Medical Care for Citizens to Whom State Guarantees Are Provided in the Form of the Provision of Medicinal Products and Specialized Therapeutic Nutrition Products (as amended by Federal Law of 26.04.2016 N 112-FL)

1. Rare (orphan) diseases are diseases which have a prevalence of not more than 10 cases of the disease per 100 thousand of the population.
2. The list of rare (orphan) diseases is formed by the authorized federal executive body on the basis of statistical data and is placed on its official website in the “Internet” network.
3. The list of life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens or to their disability, from among the diseases specified in Part 2 of this Article, is approved by the Government of the Russian Federation.
4. For the purposes of the provision of citizens suffering from diseases included in the list approved in accordance with Part 3 of this Article with medicinal products and specialized therapeutic nutrition products, the Federal Register of Persons Suffering from Life-Threatening and Chronic Progressive Rare (Orphan) Diseases Leading to a Reduction in the Life Expectancy of Citizens or to Their Disability (hereinafter in this Article – the Federal Register) is maintained, containing the following data: (as amended by Federal Law of 25.11.2013 N 317-FL)

1) the insurance number of the individual personal account of the citizen in the system of compulsory pension insurance (if any);

2) the surname, name, patronymic, and also the surname which the citizen had at birth;

3) the date of birth;

4) sex;

5) the address of the place of residence;

6) the series and number of the passport (birth certificate) or identity card, the date of issue of the said documents;

7) the date of inclusion in the Federal Register;

8) the diagnosis of the disease (state);

9) other data determined by the Government of the Russian Federation.

5. The Federal Register is maintained by the authorized federal executive body in the procedure established by the Government of the Russian Federation.
6. Bodies of state power of constituent entities of the Russian Federation maintain the regional segment of the Federal Register and ensure the timely submission of the data contained in it to the authorized federal executive body in the procedure established by the Government of the Russian Federation.
7. The organization of the provision with medicinal products of persons suffering from haemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, haemolytic-uraemic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis of types I, II and VI, aplastic anaemia, unspecified, hereditary deficiency of factors II (fibrinogen), VII (labile) X (Stuart-Prower), of persons after transplantation of organs and (or) tissues is carried out in the procedure established by the Government of the Russian Federation. The provision of the said persons with medicinal products is carried out according to the list of medicinal products approved by the Government of the Russian Federation and formed in the procedure established by it. (as amended by Federal Laws of 03.08.2018 N 299-FL, of 27.12.2019 N 452-FL)
8. For the purposes of the provision of the persons specified in Part 7 of this Article with medicinal products, the authorized federal executive body, in the procedure established by the Government of the Russian Federation, maintains the Federal Register of persons suffering from haemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, haemolytic-uraemic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis of types I, II and VI, aplastic anaemia, unspecified, hereditary deficiency of factors II (fibrinogen), VII (labile) X (Stuart-Prower), of persons after transplantation of organs and (or) tissues, which contains the following data: (as amended by Federal Laws of 03.08.2018 N 299-FL, of 27.12.2019 N 452-FL)

1) the insurance number of the individual personal account of the citizen in the system of compulsory pension insurance (if any); (as amended by Federal Law of 26.04.2016 N 112-FL)

2) the surname, name, patronymic, and also the surname which the citizen had at birth; (as amended by Federal Law of 26.04.2016 N 112-FL)

3) the date of birth; (as amended by Federal Law of 26.04.2016 N 112-FL)

4) sex; (as amended by Federal Law of 26.04.2016 N 112-FL)

5) the address of the place of residence; (as amended by Federal Law of 26.04.2016 N 112-FL)

6) the series and number of the passport (birth certificate) or identity card, the date of issue of the said documents; (as amended by Federal Law of 26.04.2016 N 112-FL)

7) the date of inclusion in the said federal register; (as amended by Federal Law of 26.04.2016 N 112-FL)

8) the diagnosis of the disease (state); (as amended by Federal Law of 26.04.2016 N 112-FL)

9) other data determined by the Government of the Russian Federation. (as amended by Federal Law of 26.04.2016 N 112-FL)

9. Bodies of state power of constituent entities of the Russian Federation maintain the regional segment of the federal register specified in Part 8 of this Article and ensure the timely submission of the data contained in it to the authorized federal executive body. (as amended by Federal Law of 26.04.2016 N 112-FL)
10. The Government of the Russian Federation is entitled to take a decision on the inclusion in the list of diseases specified in Clause 21 of Part 2 of Article 14 of this Federal Law of additional diseases for the treatment of which the provision of citizens with medicinal products is carried out at the expense of the funds of the federal budget. (as amended by Federal Law of 26.04.2016 N 112-FL)

 

Article 44.1. Federal Register of Citizens Entitled to the Provision of Medicinal Products, Medical Devices and Specialized Therapeutic Nutrition Products at the Expense of the Budget Allocations of the Federal Budget and the Budgets of Constituent Entities of the Russian Federation (as amended by Federal Law of 13.07.2020 N 206-FL)

1. For the purposes of the coordination of the activities of federal executive bodies, executive bodies of state power of constituent entities of the Russian Federation, local self-government bodies, medical organizations of the state, municipal and private health care systems in the part of the provision of citizens with medicinal products, medical devices and specialized therapeutic nutrition products at the expense of the budget allocations of the federal budget and the budgets of constituent entities of the Russian Federation, the authorized federal executive body maintains the Federal Register of Citizens Entitled to the Provision of Medicinal Products, Medical Devices and Specialized Therapeutic Nutrition Products at the Expense of the Budget Allocations of the Federal Budget and the Budgets of Constituent Entities of the Russian Federation (hereinafter in this Article – the Federal Register of Citizens), containing the following data:

1) the insurance number of the individual personal account of the citizen in the system of compulsory pension insurance (if any);

2) the surname, name, patronymic (if any) of the citizen, and also the surname which he had at birth;

3) the date of birth;

4) sex;

5) the address of the place of residence, place of stay or place of actual residence;

6) the series and number of the passport (birth certificate) or identity card, the date of issue of the said documents;

7) the number of the compulsory medical insurance policy of the insured person;

8) data on citizenship;

9) data on the grounds of stay or residence in the Russian Federation (for a foreign citizen, a stateless person, including a refugee);

10) the date of inclusion in the Federal Register of Citizens;

11) the diagnosis of the disease (state), including its code according to the International Statistical Classification of Diseases and Related Health Problems;

12) the category of citizens (group of the population) entitled to the provision of medicinal products, medical devices and specialized therapeutic nutrition products, the category of disease which is the ground for the provision of medicinal products, medical devices and specialized therapeutic nutrition products, including taking into account the List of Groups of the Population and Categories of Diseases in the Outpatient Treatment of Which Medicines and Medical Products Are Dispensed on Physicians’ Prescriptions Free of Charge, and the List of Groups of the Population in the Outpatient Treatment of Which Medicines Are Dispensed on Physicians’ Prescriptions with a Fifty Percent Discount;

13) data on the prescription and dispensing of the medicinal products, medical devices and specialized therapeutic nutrition products specified in Clause 12 of this Part;

14) other data which the Government of the Russian Federation is entitled to determine.

2. The procedure for the maintenance of the Federal Register of Citizens, including the procedure for access to the data contained in it, the procedure and terms for the submission of data to the said register, is established by the Government of the Russian Federation.
3. The data provided for by Part 1 of this Article and included in the Federal Register of Citizens are submitted from:

1) the federal registers provided for by Part 2.1 of Article 43, Parts 4 and 8 of Article 44 of this Federal Law, Part 2 of Article 6.4 of Federal Law of 17 July 1999 N 178-FL “On State Social Assistance”;

2) the state information system “Unified Centralized Digital Platform in the Social Sphere”. (as amended by Federal Law of 25.12.2023 N 635-FL)

4. Bodies of state power of constituent entities of the Russian Federation maintain the regional segments of the Federal Register of Citizens and ensure the timely submission of the data contained in them to the authorized federal executive body in the procedure established by the Government of the Russian Federation.

 

Article 45. Prohibition of Euthanasia

Medical workers are prohibited from carrying out euthanasia, that is, the acceleration, at the request of a patient, of his death by any actions (inaction) or means, including the termination of artificial measures for maintaining the life of the patient.

The provisions of Article 45.1 do not extend to persons in respect of whom, before 24.07.2023, surgical interventions aimed at changing the sex characteristics of a person were carried out and confirmed by a medical conclusion of the medical commission of a medical organization subordinate to the federal executive body for developing and implementing state policy and normative legal regulation in the sphere of health care on the conformity of the sex characteristics to the characteristics of a certain sex, issued in accordance with Part 2 of Article 45.1 (Part 2 of Article 5 of Federal Law of 24.07.2023 N 386-FL).

 

Article 45.1. Prohibition of Changing the Sex of a Person (as amended by Federal Law of 24.07.2023 N 386-FL)

1. The carrying out of medical interventions, including the application of medicinal products, aimed at changing sex, including the formation in a person of the primary and (or) secondary sex characteristics of another sex, is prohibited.
2. Change of sex does not include medical interventions related to the treatment of congenital anomalies (malformations), genetic and endocrine diseases associated with a disorder of the formation of the genital organs in children, if such medical interventions are permitted by decision of the medical commission of a medical organization subordinate to the authorized federal executive body. According to the results of such medical interventions, the said medical commission issues a medical conclusion on the conformity of the sex characteristics to the characteristics of a certain sex, necessary for introducing a change into the civil status record. The list of medical organizations subordinate to the authorized federal executive body, the form and procedure for the issuance of such decisions and medical conclusions are approved by the Government of the Russian Federation.

 

Article 46. Medical Examinations, Dispanserization

1. A medical examination is a set of medical interventions aimed at the identification of pathological states, diseases and risk factors of their development.
2. The types of medical examinations are:

1) a preventive medical examination conducted for the purposes of the early (timely) detection of states, diseases and risk factors of their development, the non-medical consumption of narcotic drugs and psychotropic substances, and also for the purposes of determining health groups and developing recommendations for patients; (as amended by Federal Law of 03.07.2016 N 286-FL)

2) a preliminary medical examination conducted upon entering employment for the purposes of determining the conformity of the state of health of the worker to the work entrusted to him, and also upon admission to study in the case provided for by Part 7 of Article 55 of Federal Law of 29 December 2012 N 273-FL “On Education in the Russian Federation”; (as amended by Federal Law of 03.07.2016 N 286-FL)

3) a periodic medical examination conducted with the established periodicity for the purposes of the dynamic observation of the state of health of workers, the timely detection of initial forms of occupational diseases, early signs of the influence of harmful and (or) dangerous production factors of the working environment, of the labour process on the state of health of workers for the purposes of forming risk groups for the development of occupational diseases, the identification of medical contraindications to the carrying out of certain types of work; (as amended by Federal Law of 03.07.2016 N 286-FL)

4) pre-shift, pre-trip medical examinations conducted before the beginning of the working day (shift, trip) for the purposes of identifying signs of the influence of harmful and (or) dangerous production factors, states and diseases hindering the performance of labour duties, including alcoholic, narcotic or other toxic intoxication and the residual effects of such intoxication;

4.1) medical examinations during the working day (shift) conducted for the purposes of identifying signs of the influence of harmful and (or) dangerous production factors of the working environment and the labour process on the state of health of workers, of an acute occupational disease or poisoning, of signs of alcoholic, narcotic or other toxic intoxication; (as amended by Federal Law of 29.12.2022 N 629-FL)

5) post-shift, post-trip medical examinations conducted at the end of the working day (shift, trip) for the purposes of identifying signs of the influence of harmful and (or) dangerous production factors of the working environment and the labour process on the state of health of workers, of an acute occupational disease or poisoning, of signs of alcoholic, narcotic or other toxic intoxication;

6) other types of medical examinations established by the legislation of the Russian Federation. (as amended by Federal Law of 25.11.2013 N 317-FL)

3. Part has ceased to be in force. (as amended by Federal Law of 03.07.2016 N 286-FL)
4. Dispanserization is a set of measures including a preventive medical examination and additional methods of examination conducted for the purposes of assessing the state of health (including the determination of the health group and the dispensary observation group) and carried out in respect of certain groups of the population in accordance with the legislation of the Russian Federation. (as amended by Federal Law of 03.07.2016 N 286-FL)
5. Dispensary observation is a necessary examination, conducted with a certain periodicity, of persons suffering from chronic diseases, functional disorders, other states, including in connection with the propensity of such persons to commit socially dangerous acts, for the purposes of the timely detection, prevention of complications, exacerbations of diseases, other states, their prevention and the carrying out of the medical rehabilitation of the said persons, conducted in the procedure established by the authorized federal executive body. (as amended by Federal Laws of 03.07.2016 N 286-FL, of 22.07.2024 N 195-FL)
6. In the cases established by the legislation of the Russian Federation, undergoing and conducting medical examinations, dispanserization and dispensary observation are mandatory.
7. The procedure and periodicity of the conduct of medical examinations, dispanserization, dispensary observation and the list of studies included in them are approved by the authorized federal executive body, unless otherwise provided for by the legislation of the Russian Federation. In the conduct of medical examinations, dispanserization, the results of previously conducted (not more than one year earlier) medical examinations, dispanserization confirmed by the medical documents of the patient may be taken into account. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 03.07.2016 N 286-FL)
8. The procedures and periodicity of the conduct of preliminary, periodic, pre-shift, pre-trip, post-shift, post-trip medical examinations, medical examinations during the working day (shift), the necessity of the conduct of which is established by other federal laws in respect of certain categories of workers, and the list of studies included in them are approved by the authorized federal executive body, unless otherwise provided for by the legislation of the Russian Federation. (as amended by Federal Law of 29.12.2022 N 629-FL)
9. The conduct of the medical examinations specified in Clauses 4, 4.1 and 5 of Part 2 of this Article with the use of medical devices ensuring the automated remote transmission of information on the state of health of workers and remote control of the state of their health is permitted. In the conduct of medical examinations with the use of the said medical devices, the identification of the person of the worker undergoing the medical examination must be ensured, excluding the undergoing of the medical examination by another person, in accordance with the legislation of the Russian Federation. (as amended by Federal Law of 29.12.2022 N 629-FL)
10. Persons organizing and conducting the medical examinations specified in Clauses 4, 4.1 and 5 of Part 2 of this Article with the use of medical devices ensuring the automated remote transmission of information on the state of health of workers and remote control of the state of their health bear liability in accordance with the legislation of the Russian Federation for the completeness and reliability of the data transmitted. (as amended by Federal Law of 29.12.2022 N 629-FL)
11. In the case of the conduct of the medical examinations specified in Clauses 4, 4.1 and 5 of Part 2 of this Article with the use of medical devices ensuring the automated remote transmission of information on the state of health of workers and remote control of the state of their health, chemical and toxicological studies of the presence (absence) in the human organism of narcotic drugs, psychotropic substances and their metabolites are conducted in person in respect of the worker not less than twice a year. (as amended by Federal Law of 29.12.2022 N 629-FL)
12. The specifics of the conduct of medical examinations with the use of medical devices ensuring the automated remote transmission of information on the state of health of workers and remote control of the state of their health, including the necessity of conducting a visual examination, the requirements for the said medical devices, their verification and the software making it possible to exclude the possibility of falsification of the data of the medical examination, and for ensuring the possibility of generating the relevant details of waybills, including in the form of an electronic document, the requirements for workers conducting the medical examination, and also the rules for the conduct of chemical and toxicological studies of the presence (absence) in the human organism of narcotic drugs, psychotropic substances and their metabolites in respect of workers undergoing a medical examination with the use of the said medical devices, are established by the Government of the Russian Federation. The requirements for the identification of the person of the worker undergoing the medical examination, the requirements for the collection, storage and transmission of personal data via protected communication channels are established in accordance with the legislation of the Russian Federation in the field of personal data. (as amended by Federal Law of 29.12.2022 N 629-FL)

 

Article 47. Donation of Human Organs and Tissues and Their Transplantation (Grafting)

1. The transplantation (grafting) of human organs and tissues from a living donor or a corpse may be applied only if other methods of treatment cannot ensure the preservation of the life of the patient (recipient) or the restoration of his health.
2. The removal of organs and tissues for transplantation (grafting) from a living donor is admissible only if, according to the conclusion of the medical commission of a medical organization with the involvement of the relevant specialist physicians, executed in the form of a protocol, significant harm will not be caused to his health.
3. The removal of organs and tissues for transplantation (grafting) is not permitted from a living person who has not reached the age of eighteen (except for cases of transplantation of bone marrow and haematopoietic stem cells) or who has been recognized as legally incapable in the procedure established by law. (as amended by Federal Law of 01.05.2022 N 129-FL)
4. The removal of organs and tissues for transplantation (grafting) from a living donor is permitted if there is his informed voluntary consent.
5. The transplantation (grafting) of human organs and tissues is permitted if there is the informed voluntary consent of an adult legally capable recipient, and in respect of a minor recipient, and also in respect of a recipient recognized as legally incapable in the procedure established by law, if he, due to his state, is unable to give informed voluntary consent – if there is the informed voluntary consent of one of the parents or another legal representative given in the procedure established by the authorized federal executive body.
6. An adult legally capable citizen may, orally in the presence of witnesses or in writing certified by the head of a medical organization or by a notary, express his will on consent or non-consent to the removal of organs and tissues from his body after death for transplantation (grafting) in the procedure established by the legislation of the Russian Federation.
7. In the absence of an expression of will of an adult legally capable deceased person, the right to declare their non-consent to the removal of organs and tissues from the body of the deceased for transplantation (grafting) belongs to the spouse, and in his (her) absence – to one of the close relatives (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother).
8. In the event of the death of a minor or a person recognized as legally incapable in the established procedure, the removal of organs and tissues from the body of the deceased for transplantation (grafting) is permitted on the basis of the requested consent of one of the parents.
9. Information on the existence of an expression of will of the citizen specified in Part 6 of this Article, of other persons in the cases provided for by Parts 7 and 8 of this Article, expressed orally or in writing certified in the procedure provided for by Part 6 of this Article, is entered into the medical documentation of the citizen.
10. The removal of organs and tissues for transplantation (grafting) from a corpse is not permitted if the medical organization, at the moment of removal, has been notified in the procedure established by the legislation of the Russian Federation that this person during his lifetime, or other persons in the cases specified in Parts 7 and 8 of this Article, declared their non-consent to the removal of his organs and tissues after death for transplantation (grafting).
11. Organs and tissues for transplantation (grafting) may be removed from a corpse after the pronouncement of death in accordance with Article 66 of this Federal Law.
12. In the event of the necessity of conducting a forensic medical expert examination, permission for the removal of organs and tissues from a corpse for transplantation (grafting) must be given by a forensic medical expert with notification of the prosecutor thereof.
13. Coercion to the removal of human organs and tissues for transplantation (grafting) is not permitted.
14. In the Russian Federation, the recording of donor human organs and tissues, donors of organs and tissues, patients (recipients) is carried out in the procedure established by the authorized federal executive body. The financial support of measures related to the organization and maintenance of the recording of donor human organs and tissues, donors of organs and tissues, patients (recipients) is carried out at the expense of the budget allocations provided for in the federal budget to the authorized federal executive body. (as amended by Federal Law of 13.07.2015 N 271-FL)
15. The donation of human organs and tissues and their transplantation (grafting) are carried out in accordance with a federal law.
16. The procedure for the financial support of medical activity related to the donation of human organs, bone marrow and haematopoietic stem cells for the purposes of transplantation (grafting) at the expense of the budget allocations provided for in the federal budget to the authorized federal executive body is established by the Government of the Russian Federation in accordance with the budget legislation of the Russian Federation. (as amended by Federal Laws of 13.07.2015 N 271-FL, of 01.05.2022 N 129-FL)
17. For the purposes of the organization of medical activity related to the transplantation (grafting) of bone marrow and haematopoietic stem cells, and also to the donation of bone marrow and haematopoietic stem cells, the Federal Register of Donors of Bone Marrow and Haematopoietic Stem Cells, Donor Bone Marrow and Haematopoietic Stem Cells, Recipients of Bone Marrow and Haematopoietic Stem Cells (hereinafter in this Article – the Federal Register) is maintained, containing the following data on donors, recipients and persons who have expressed the intention to become donors of bone marrow and (or) haematopoietic stem cells: (as amended by Federal Law of 01.05.2022 N 129-FL)

1) the insurance number of the individual personal account of the citizen in the system of compulsory pension insurance (if any); (as amended by Federal Law of 01.05.2022 N 129-FL)

2) the surname, name, patronymic (if any) of the citizen, the surname which he had at birth, and also information on all cases of change of surname and (or) name during the life of the citizen; (as amended by Federal Law of 01.05.2022 N 129-FL)

3) the date of birth; (as amended by Federal Law of 01.05.2022 N 129-FL)

4) sex; (as amended by Federal Law of 01.05.2022 N 129-FL)

5) the address of the place of residence; (as amended by Federal Law of 01.05.2022 N 129-FL)

6) the series and number of the passport (birth certificate) or another identity document, the date of issue of the said documents; (as amended by Federal Law of 01.05.2022 N 129-FL)

7) the unique identification number; (as amended by Federal Law of 01.05.2022 N 129-FL)

8) the date of inclusion in the Federal Register; (as amended by Federal Law of 01.05.2022 N 129-FL)

9) the results of the medical examination of the person who has expressed the intention to become a donor of bone marrow and (or) haematopoietic stem cells and the results of the medical examination of the donor of bone marrow and (or) haematopoietic stem cells; (as amended by Federal Law of 01.05.2022 N 129-FL)

10) data on the removal of bone marrow and haematopoietic stem cells; (as amended by Federal Law of 01.05.2022 N 129-FL)

11) other data determined by the Government of the Russian Federation. (as amended by Federal Law of 01.05.2022 N 129-FL)

18. The creation, maintenance and development of the Federal Register are carried out by the federal executive body exercising the functions of organizing the activities of the blood service. The procedure for the maintenance of the Federal Register, including the terms and procedure for the submission of data to the Federal Register, the list of data exchanged with the use of the unified state information system in the sphere of health care, the procedure for access to the data contained in the Federal Register and their use, is established by the Government of the Russian Federation. (as amended by Federal Law of 01.05.2022 N 129-FL)

 

Article 48. Medical Commission and Konsilium of Physicians

1. The medical commission consists of physicians and is headed by the head of the medical organization or one of his deputies.
2. The medical commission is created in a medical organization for the purposes of improving the organization of the provision of medical care, taking decisions in the most complex and conflict cases on matters of prevention, diagnosis, treatment and medical rehabilitation, determining the working capacity of citizens and the occupational fitness of certain categories of workers, carrying out the assessment of the quality, validity and effectiveness of therapeutic and diagnostic measures, including the prescription of medicinal products, ensuring the prescription and correction of treatment for the purposes of recording patient data in the provision of medicinal products, the transplantation (grafting) of human organs and tissues, medical rehabilitation, and also taking decisions on other medical matters. The decision of the medical commission is executed in a protocol and entered into the medical documentation of the patient.
3. A konsilium of physicians is a meeting of several physicians of one or several specialties necessary for establishing the state of health of the patient, the diagnosis, determining the prognosis and tactics of medical examination and treatment, the expediency of referral to specialized departments of the medical organization or to another medical organization and for resolving other matters in the cases provided for by this Federal Law.
4. A konsilium of physicians is convened on the initiative of the attending physician in the medical organization or outside the medical organization (including a remote konsilium of physicians). The decision of the konsilium of physicians is executed in a protocol, signed by the participants of the konsilium of physicians and entered into the medical documentation of the patient. The protocol of the konsilium of physicians indicates the surnames of the physicians included in the composition of the konsilium of physicians, data on the reasons for the conduct of the konsilium of physicians, the course of the disease of the patient, the state of the patient at the moment of the conduct of the konsilium of physicians, including the interpretation of clinical data, laboratory, instrumental and other methods of study, and the decision of the konsilium of physicians. If a participant of the konsilium of physicians has a dissenting opinion, a corresponding entry is made in the protocol. The opinion of a participant of a remote konsilium of physicians is entered into the protocol from his words by the medical worker present next to the patient.

 

Article 49. Medical Waste

(as amended by Federal Law of 08.08.2024 N 306-FL)

1. Medical waste is anatomical, pathologic-anatomical, biochemical, microbiological, physiological and other waste generated in the process of carrying out medical activity, pharmaceutical activity, activity in the production of medicines, activity in the field of the use of pathogens of infectious diseases and genetically engineered modified organisms for medical purposes, and also in the production and storage of biomedical cellular products.
2. Medical waste is divided, according to the degree of its epidemiological, toxicological, radiation hazard, and also negative influence on the human habitat, in accordance with the criteria established by the Government of the Russian Federation, into the following classes:

1) class “А” – epidemiologically safe waste, close in composition to solid municipal waste;

2) class “Б” – epidemiologically hazardous waste;

3) class “В” – extremely epidemiologically hazardous waste;

4) class “Г” – toxicological hazardous waste, close in composition to industrial waste;

5) class “Д” – radioactive waste.

3. The handling of medical waste and its recording are carried out in accordance with the legislation of the Russian Federation.

 

 

Article 50. Folk Medicine

1. Folk medicine consists of methods of health improvement established in popular experience, which are based on the use of knowledge, abilities and practical skills in the assessment and restoration of health. Folk medicine does not include the provision of services of an occult-magical nature, nor the performance of religious rites.
2. The right to practise folk medicine belongs to a citizen who has received a permit issued by the executive body of a constituent entity of the Russian Federation in the sphere of health protection. (as amended by Federal Law of 08.08.2024 N 232-FL)
3. The decision on the issuance of a permit to practise folk medicine is taken on the basis of the application of the citizen and the submission of a medical professional non-commercial organization, or the application of the citizen and the joint submission of a medical professional non-commercial organization and a medical organization. The permit gives the right to practise folk medicine in the territory of the constituent entity of the Russian Federation whose executive body issued such permit. (as amended by Federal Law of 08.08.2024 N 232-FL)
4. A person who has received a permit practises folk medicine in the procedure established by the executive body of the constituent entity of the Russian Federation. (as amended by Federal Law of 08.08.2024 N 232-FL)
5. The deprivation of a citizen of the permit to practise folk medicine is carried out by decision of the executive body of the constituent entity of the Russian Federation that issued such permit and may be appealed to a court. (as amended by Federal Law of 08.08.2024 N 232-FL)
6. Folk medicine is not included in the programme of state guarantees of the free provision of medical care to citizens.
7. The unlawful practice of folk medicine, and also the causing of harm to the life or health of citizens in the practice of folk medicine, entails liability provided for by the legislation of the Russian Federation.

 

Chapter 6. PROTECTION OF THE HEALTH OF MOTHER AND CHILD, MATTERS OF THE FAMILY AND REPRODUCTIVE HEALTH

 

Article 51. Rights of the Family in the Sphere of Health Protection

1. Every citizen has the right, on medical indications, to consultations without charging a fee on matters of family planning, the presence of socially significant diseases and diseases posing a danger to others, on the medical and psychological aspects of family and marital relations, and also to medical genetic and other consultations and examinations in medical organizations of the state health care system for the purposes of preventing possible hereditary and congenital diseases in offspring.
2. The father of the child or another family member is granted the right, with the consent of the woman and taking into account the state of her health, to be present at the birth of the child, except for cases of operative delivery, if the obstetric institution has the appropriate conditions (individual delivery rooms) and the father or other family member does not have infectious diseases. The realization of such right is carried out without charging a fee to the father of the child or other family member.
3. One of the parents, another family member or another legal representative is granted the right to free joint stay with a child in a medical organization during the provision of medical care to him in inpatient conditions, irrespective of the age of the child, during the entire period of treatment. A fee for the creation of conditions of stay in inpatient conditions, including for the provision of a sleeping place and food, is not charged to the said persons in the case of joint stay in a medical organization:

1) with a disabled child who, in accordance with the individual programme of rehabilitation or habilitation of the disabled child issued according to the results of a medical and social expert examination, has limitations of the main categories of human life activity of the second and (or) third degrees of severity (limitations of the ability to self-care, and (or) independent movement, and (or) orientation, and (or) communication, and (or) learning, and (or) control of one’s behaviour) – irrespective of the age of the disabled child;

2) with a child until he reaches the age of four years;

3) with a child aged over four years – if there are medical indications. (as amended by Federal Law of 14.07.2022 N 317-FL)

 

Article 52. Rights of Pregnant Women and Mothers in the Sphere of Health Protection

1. Motherhood in the Russian Federation is protected and encouraged by the state.
2. Every woman during pregnancy, during childbirth and after childbirth is provided with medical care in medical organizations within the framework of the programme of state guarantees of the free provision of medical care to citizens.
3. The provision of full-value nutrition to pregnant women, nursing mothers, and also children under the age of three years, including through special nutrition points and trade organizations, is carried out on the conclusion of physicians in accordance with the legislation of constituent entities of the Russian Federation.

 

Article 53. Birth of a Child

1. The moment of birth of a child is the moment of separation of the foetus from the organism of the mother by means of childbirth.
2. Upon the birth of a live child, the medical organization in which the childbirth took place issues a document of the established form.
3. The medical criteria of birth, including the terms of pregnancy, the body weight of the child at birth and the signs of live birth, and also the procedure for the issuance of the document on birth and its form, are approved by the authorized federal executive body.

 

Article 53.1. Federal Register of Medical Documents on Birth (as amended by Federal Law of 02.07.2021 N 358-FL)

1. For the purposes of the coordination of the activities of federal executive bodies, executive bodies of constituent entities of the Russian Federation, local self-government bodies, medical organizations of the state, municipal and private health care systems in the part of keeping records of data on birth, the authorized federal executive body maintains, as part of the unified state information system in the sphere of health care, the Federal Register of Medical Documents on Birth (hereinafter in this Article – the Federal Register), containing documents on birth generated in the form of an electronic document, and also data on the born child and his mother provided for by the form of the document on birth approved by the authorized federal executive body. (as amended by Federal Law of 08.08.2024 N 232-FL)
2. The procedure for the maintenance of the Federal Register, including the procedure for access to the data contained in it, the procedure and terms for the submission of data to the said register, is established by the Government of the Russian Federation.
3. The data included in the Federal Register are submitted by medical organizations, except for the data specified in Part 5 of this Article.
4. The Federal Register ensures the storage of documents on birth generated in the form of an electronic document. In the event of the issuance of a document on birth on paper, the data on the born child and his mother are entered into the Federal Register by the medical organization in the procedure and within the terms which are established by the Government of the Russian Federation.
5. If state information systems contain data on the mother of the born child, the formation and (or) collection of which are carried out by bodies of state power of the Russian Federation, management bodies of state extra-budgetary funds in accordance with their powers established by federal laws, the said data and (or) information making it possible to identify such data in state information systems are submitted by the bodies and organizations to the Federal Register in accordance with the procedure for the maintenance of the said register.
6. Documents on birth which are contained in the Federal Register and, in the cases determined by Federal Law of 15 November 1997 N 143-FL “On Acts of Civil Status”, are the basis for the state registration of birth, are transferred, for the purposes of the state registration of birth, to the Unified State Register of Records of Acts of Civil Status in the procedure and within the terms which are established by the Government of the Russian Federation.
7. The data on the born child and his mother contained in the Federal Register are transferred to the federal executive body exercising the functions of forming official statistical information on social, economic, demographic, environmental and other public processes in the Russian Federation (its territorial bodies) in the procedure and within the terms which are established by the Government of the Russian Federation.

 

Article 54. Rights of Minors in the Sphere of Health Protection

1. In the sphere of health protection, minors have the right to:

1) undergoing medical examinations, including preventive medical examinations, in connection with engaging in physical culture and sports, undergoing dispanserization, dispensary observation, medical rehabilitation, the provision of medical care, including during the period of education and upbringing in educational organizations, in the procedure established by the authorized federal executive body and on the conditions established by bodies of state power of constituent entities of the Russian Federation; (as amended by Federal Laws of 02.07.2013 N 185-FL, of 03.07.2016 N 286-FL)

2) the provision of medical care during the period of health improvement and organized recreation in the procedure established by the authorized federal executive body;

3) sanitary and hygienic education, study and work in conditions corresponding to their physiological specifics and state of health and excluding the influence of adverse factors on them;

4) medical consultation without charging a fee in the determination of occupational fitness in the procedure and on the conditions which are established by bodies of state power of constituent entities of the Russian Federation;

5) receiving information on the state of health in a form accessible to them in accordance with Article 22 of this Federal Law.

2. Minors aged over fifteen years or minors suffering from drug addiction aged over sixteen years have the right to informed voluntary consent to medical intervention or to refuse it in accordance with this Federal Law, except for cases of the provision of medical care to them in accordance with Parts 2 and 9 of Article 20 of this Federal Law. (as amended by Federal Law of 25.11.2013 N 317-FL)
3. Orphan children, children left without parental care, and children in a difficult life situation, until they reach the age of four years inclusive, may be kept in medical organizations of the state health care system and the municipal health care system in the procedure established by the authorized federal executive body and on the conditions established by bodies of state power of constituent entities of the Russian Federation.
4. Minors, in the provision of medical care to them, may be prescribed medicinal products included in the standards of medical care for children and clinical guidelines and applied in accordance with indicators (characteristics) of the medicinal product not specified in the instructions for its use, in accordance with Part 14.1 of Article 37 of this Federal Law. (as amended by Federal Law of 30.12.2021 N 482-FL)
5. Persons suffering from diseases or states (groups of diseases or states) included in the list of diseases or states (groups of diseases or states) established by the authorized federal executive body are entitled, upon reaching the age of majority, until they reach the age of twenty-one years, to be observed and to continue treatment in the medical organization that provided medical care to them for such diseases or states (groups of diseases or states) before they reached the age of majority. (as amended by Federal Law of 30.12.2021 N 482-FL)

 

Article 55. Application of Assisted Reproductive Technologies

1. Assisted reproductive technologies are methods of treatment of infertility in the application of which individual or all stages of conception and early development of embryos are carried out outside the maternal organism (including with the use of donor and (or) cryopreserved germ cells, tissues of reproductive organs and embryos), and also surrogate motherhood. (as amended by Federal Law of 19.12.2022 N 538-FL)
2. The procedure for the use of assisted reproductive technologies, contraindications and restrictions on their application are approved by the authorized federal executive body.

The provisions of Part 3 of Article 55 of this document (as worded by Federal Law of 19.12.2022 N 538-FL) in the part of the mandatory condition of the existence of a registered marriage, and also of the citizenship of the RF of one of the potential parents, or of a single woman, or of the surrogate mother, do not apply in respect of cases where the surrogate mother, on the day of 19.12.2022, is already carrying a child in accordance with the contract specified in Part 9 of Article 55 of this document (as worded before 19.12.2022), concluded with the potential parents or with a single woman, or has given birth to a child in accordance with the said contract (Clause 2 of Article 5 of Federal Law of 19.12.2022 N 538-FL).

3. A man and a woman, both married and not married, have the right to the application of assisted reproductive technologies if there is mutual informed voluntary consent to medical intervention. The right to the application of assisted reproductive technologies in the form of surrogate motherhood does not extend to a man and a woman who are not married. A single woman also has the right to the application of assisted reproductive technologies if there is her informed voluntary consent to medical intervention. (as amended by Federal Law of 19.12.2022 N 538-FL)
4. In the use of assisted reproductive technologies, the choice of the sex of the future child is not permitted, except for cases of the possibility of inheritance of sex-linked diseases.
5. Citizens have the right to the cryopreservation and storage of their germ cells, tissues of reproductive organs and embryos at the expense of personal funds and other funds provided for by the legislation of the Russian Federation.
6. Human germ cells, tissues of reproductive organs and embryos may not be used for industrial purposes.
7. Citizens aged from eighteen to thirty-five years, physically and mentally healthy, who have undergone a medical genetic examination have the right to be donors of germ cells.
8. In the use of donor germ cells and embryos, citizens have the right to receive information on the results of the medical, medical genetic examination of the donor, on his race and nationality, and also on his external appearance.

The provisions of Part 9 of Article 55 of this document (as worded by Federal Law of 19.12.2022 N 538-FL) in the part of the mandatory condition of the existence of a registered marriage, and also of the citizenship of the RF of one of the potential parents, or of a single woman, or of the surrogate mother, do not apply in respect of cases where the surrogate mother, on the day of 19.12.2022, is already carrying a child in accordance with the contract specified in Part 9 of Article 55 of this document (as worded before 19.12.2022), concluded with the potential parents or with a single woman, or has given birth to a child in accordance with the said contract (Clause 2 of Article 5 of Federal Law of 19.12.2022 N 538-FL).

9. Surrogate motherhood is the carrying and birth of a child (including premature birth) under a surrogate motherhood contract concluded between a surrogate mother (a woman carrying a foetus after the transfer of a donor embryo) and the potential parents whose germ cells were used for fertilization, for whom the carrying and birth of a child are impossible on medical indications (hereinafter – the potential parents (the genetic mother and the genetic father) and who are married to each other, or a single woman whose germ cells were used for fertilization and for whom the carrying and birth of a child are impossible on medical indications (hereinafter – the single woman (the genetic mother). The procedure for establishing the potential parents as the genetic mother and the genetic father, and equally a single woman as the genetic mother, is determined by the Government of the Russian Federation. (as amended by Federal Law of 19.12.2022 N 538-FL)
10. A surrogate mother may be a woman aged from twenty to thirty-five years, having the citizenship of the Russian Federation, having at least one healthy own child, having received a medical conclusion on a satisfactory state of health, having given written informed voluntary consent to medical intervention. A woman who is in a marriage registered in the procedure established by the legislation of the Russian Federation may be a surrogate mother only with the written consent of the spouse. A surrogate mother may not simultaneously be an egg donor. (as amended by Federal Law of 19.12.2022 N 538-FL)

The provisions of Part 11 of Article 55 of this document (as worded by Federal Law of 19.12.2022 N 538-FL) in the part of the mandatory condition of the existence of a registered marriage, and also of the citizenship of the RF of one of the potential parents, or of a single woman, or of the surrogate mother, do not apply in respect of cases where the surrogate mother, on the day of 19.12.2022, is already carrying a child in accordance with the contract specified in Part 9 of Article 55 of this document (as worded before 19.12.2022), concluded with the potential parents or with a single woman, or has given birth to a child in accordance with the said contract (Clause 2 of Article 5 of Federal Law of 19.12.2022 N 538-FL).

11. One of the potential parents (the genetic mother or the genetic father) or both potential parents (the genetic mother and the genetic father), or the single woman (the genetic mother), specified in Part 9 of this Article, must have the citizenship of the Russian Federation. (as amended by Federal Law of 19.12.2022 N 538-FL)

 

Article 56. Artificial Termination of Pregnancy

1. Every woman independently decides the matter of motherhood. The artificial termination of pregnancy is carried out at the wish of the woman if there is informed voluntary consent.
2. The artificial termination of pregnancy at the wish of the woman is carried out at a term of pregnancy of up to twelve weeks.
3. The artificial termination of pregnancy is carried out:

1) not earlier than 48 hours from the moment of the woman’s application to a medical organization for the artificial termination of pregnancy:

а) at a term of pregnancy of the fourth – seventh weeks;

б) at a term of pregnancy of the eleventh – twelfth weeks, but not later than the end of the twelfth week of pregnancy;

2) not earlier than seven days from the moment of the woman’s application to a medical organization for the artificial termination of pregnancy at a term of pregnancy of the eighth – tenth weeks of pregnancy.

4. The artificial termination of pregnancy on social indications is carried out at a term of pregnancy of up to twenty-two weeks, and if there are medical indications – irrespective of the term of pregnancy.
5. Social indications for the artificial termination of pregnancy are determined by the Government of the Russian Federation.
6. The list of medical indications for the artificial termination of pregnancy is determined by the authorized federal executive body.
7. The artificial termination of pregnancy of an adult woman recognized as legally incapable in the procedure established by law, if she, due to her state, is unable to express her will, is possible by a court decision taken upon the application of her legal representative and with the participation of the adult woman recognized as legally incapable in the procedure established by law.
8. The unlawful conduct of the artificial termination of pregnancy entails administrative or criminal liability established by the legislation of the Russian Federation. (as amended by Federal Law of 21.07.2014 N 243-FL)

 

Article 57. Medical Sterilization

1. Medical sterilization as a special medical intervention for the purposes of depriving a person of the ability to reproduce offspring or as a method of contraception may be carried out only upon the written application of a citizen aged over thirty-five years or a citizen having at least two children, and if there are medical indications and the informed voluntary consent of the citizen – irrespective of age and the presence of children.
2. Upon the application of the legal representative of an adult person recognized as legally incapable in the procedure established by law, if such person, due to his state, is unable to express his will, medical sterilization is possible by a court decision taken with the participation of the adult person recognized as legally incapable in the procedure established by law.
3. The list of medical indications for medical sterilization is determined by the authorized federal executive body.

 

Chapter 7. MEDICAL EXPERT EXAMINATION AND MEDICAL CERTIFICATION

 

Article 58. Medical Expert Examination

1. A medical expert examination is a study conducted in the established procedure aimed at establishing the state of health of a citizen for the purposes of determining his ability to carry out labour or other activity, and also of establishing a cause-and-effect relationship between the influence of any events, factors and the state of health of the citizen.
2. The following types of medical expert examinations are conducted in the Russian Federation:

1) expert examination of temporary incapacity for work;

2) medical and social expert examination;

3) military medical expert examination;

4) forensic medical and forensic psychiatric expert examinations;

5) expert examination of occupational fitness and expert examination of the connection of a disease with the occupation;

6) expert examination of the quality of medical care.

3. Citizens have the right to the conduct of an independent medical expert examination in the procedure and in the cases which are established by the regulations on independent medical expert examination approved by the Government of the Russian Federation.
4. In the case provided for by Article 61 of this Federal Law, an independent military medical expert examination may be conducted.

 

Article 59. Expert Examination of Temporary Incapacity for Work

1. The expert examination of the temporary incapacity for work of citizens in connection with diseases, traumas, poisonings and other states associated with the temporary loss of working capacity, treatment in sanatorium and resort organizations, in the event of the necessity to care for a sick family member, in connection with quarantine, for the period of prosthetics in inpatient conditions, in connection with pregnancy and childbirth, upon the adoption of a child, is conducted for the purposes of determining the ability of the worker to carry out labour activity, the necessity and terms of the temporary or permanent transfer of the worker to other work due to the state of health, and also of taking a decision on referring the citizen to a medical and social expert examination. (as amended by Federal Law of 30.04.2021 N 126-FL (as amended on 26.05.2021))
2. The expert examination of temporary incapacity for work is conducted by the attending physician, who solely generates in the form of an electronic document or, in individual cases, issues in the form of a document on paper a certificate of incapacity for work for a period of up to fifteen calendar days inclusive, and in the cases established by the authorized federal executive body – by a feldsher or a dentist, who solely generate in the form of an electronic document or, in individual cases, issue in the form of a document on paper a certificate of incapacity for work for a period of up to ten calendar days inclusive. (as amended by Federal Law of 30.04.2021 N 126-FL (as amended on 26.05.2021))
3. The extension of a certificate of incapacity for work for a longer period than that specified in Part 2 of this Article (but not more than for fifteen calendar days at a time) is carried out by decision of the medical commission appointed by the head of the medical organization from among the physicians who have undergone training on matters of the conduct of the expert examination of temporary incapacity for work.

3.1. The expert examination of temporary incapacity for work in connection with pregnancy and childbirth, upon the adoption of a child, is conducted by the attending physician or, in the cases established by the authorized federal executive body, by a feldsher, who at one time generate in the form of an electronic document or, in individual cases, issue in the form of a document on paper a certificate of incapacity for work in the procedure and for the period which are established by the authorized federal executive body. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 30.04.2021 N 126-FL (as amended on 26.05.2021))

3.2. A certificate of incapacity for work is generated in the form of an electronic document signed with the use of an enhanced qualified electronic signature by the medical worker and the medical organization, or is issued in the form of a document on paper in the cases established by the legislation of the Russian Federation. (as amended by Federal Law of 30.04.2021 N 126-FL (as amended on 26.05.2021))

4. In the event of an obviously unfavourable clinical and labour prognosis, not later than four months from the date of the beginning of temporary incapacity for work, the patient is referred to undergo a medical and social expert examination for the purposes of assessing the limitation of life activity, and in the event of refusal to undergo the medical and social expert examination the certificate of incapacity for work is closed. In the event of a favourable clinical and labour prognosis, not later than ten months from the date of the beginning of temporary incapacity for work in a state after traumas and reconstructive operations and not later than twelve months in the treatment of tuberculosis, the patient is either discharged to engage in labour activity or referred to a medical and social expert examination.
5. When executing a certificate of incapacity for work, for the purposes of observing medical secrecy, only the cause of temporary incapacity for work (disease, trauma or another cause) is indicated. Upon the written application of the citizen, data on the diagnosis of the disease may be entered into the certificate of incapacity for work.
6. The procedure for the conduct of the expert examination of temporary incapacity for work is established by the authorized federal executive body.
7. The Pension and Social Insurance Fund of the Russian Federation, for the purposes of assessing the validity of the expenditure of the funds of compulsory social insurance on the payment of benefits for temporary incapacity for work, for pregnancy and childbirth, in the procedure established by the authorized federal executive body, is entitled to carry out verification of compliance with the procedure for the issuance, extension and execution of certificates of incapacity for work. (as amended by Federal Laws of 30.04.2021 N 126-FL (as amended on 26.05.2021), of 28.12.2022 N 569-FL)

 

Article 60. Medical and Social Expert Examination

1. A medical and social expert examination is conducted for the purposes of determining the needs of the person being certified for measures of social protection, including rehabilitation, by federal institutions of medical and social expert examination on the basis of an assessment of the limitations of life activity caused by a persistent disorder of the functions of the organism.
2. A medical and social expert examination is conducted in accordance with the legislation of the Russian Federation on the social protection of disabled persons.

 

Article 61. Military Medical Expert Examination

1. A military medical expert examination is conducted for the purposes of:

1) determining fitness for military service (service equated to it), training (service) in specific military registration specialties (specialties in accordance with the position held);

2) establishing the causal connection of injuries (wounds, traumas, contusions), diseases in military servicemen (persons equated to them, citizens called up for military training sessions) and citizens discharged from military service (service equated to it, military training sessions) with the undergoing of military service (service equated to it);

3) resolving other matters provided for by the legislation of the Russian Federation.

2. The regulations on military medical expert examination, providing for the procedure for the conduct of military medical expert examination in federal executive bodies and federal state bodies in which a federal law provides for military service (service equated to it), and in special formations created for wartime, including the procedure for the conduct of the medical examination and medical certification of citizens upon their registration for military records, conscription for military service, entry into military service under contract or service equated to it, entry into military professional educational organizations or military educational organizations of higher education, call-up for military training sessions, of citizens previously recognized as of limited fitness for military service due to the state of health, of citizens undergoing alternative civilian service, and also the requirements for the state of health of citizens subject to conscription for military service, who have expressed a wish to conclude with the Ministry of Defence of the Russian Federation a contract on training in a military training centre at a federal state educational organization of higher education under a military training programme or in a military educational organization of higher education under a programme of military training of reserve sergeants, petty officers or a programme of military training of reserve soldiers, sailors, being called up for military training sessions (undergoing military training sessions), entering military service under contract or service equated to it, military professional educational organizations or military educational organizations of higher education, of military servicemen and citizens in the reserve, are approved by the Government of the Russian Federation. In this regard, the medical certification of citizens who have expressed a wish to conclude with the Ministry of Defence of the Russian Federation a contract on training in a military training centre at a federal state educational organization of higher education under a military training programme or in a military educational organization of higher education under a programme of military training of reserve sergeants, petty officers or a programme of military training of reserve soldiers, sailors, is carried out in the procedure provided for by the said Regulations. (as amended by Federal Law of 03.08.2018 N 309-FL)

The operation of the provisions of Part 3 of Article 61 (as worded by Federal Law of 01.07.2017 N 154-FL) extends to legal relations that arose from 01.01.2017 (Clause 2 of Article 4 of Federal Law of 01.07.2017 N 154-FL).

3. The requirements for the state of health of citizens, except for those specified in Part 4 of this Article, are established by the relevant federal executive bodies and federal state bodies in which citizens undergo military service (service equated to it). (as amended by Federal Law of 01.07.2017 N 154-FL)
4. The requirements for the state of health of citizens being sent to alternative civilian service or undergoing alternative civilian service are similar to the requirements imposed on citizens being conscripted for military service or undergoing military service by conscription.
5. The conclusions of a military medical expert examination are mandatory for execution by officials in the territory of the Russian Federation.
6. In the event of disagreement of citizens with the conclusion of a military medical expert examination, an independent military medical expert examination is conducted upon their application. The regulations on independent military medical expert examination are approved by the Government of the Russian Federation.
7. An expert examination is recognized as independent if the expert or the members of the expert commission conducting it are not in service or other dependence on the institution or commission that conducted the military medical expert examination, and also on the bodies, institutions, officials and citizens interested in the results of the independent military medical expert examination.
8. In the conduct of an independent military medical expert examination, citizens are granted the right to choose the expert institution and the experts.
9. In the cases established by the legislation of the Russian Federation, undergoing and conducting a military medical expert examination are mandatory.

 

Article 62. Forensic Medical and Forensic Psychiatric Expert Examinations

1. Forensic medical and forensic psychiatric expert examinations are conducted for the purposes of establishing the circumstances subject to proof in a specific case, in medical organizations, by experts in accordance with the legislation of the Russian Federation on state forensic expert activity.
2. The procedure for the conduct of forensic medical and forensic psychiatric expert examinations and the procedure for determining the degree of severity of harm caused to human health are established by the authorized federal executive body.

 

Article 63. Expert Examination of Occupational Fitness and Expert Examination of the Connection of a Disease with the Occupation

1. The expert examination of occupational fitness is conducted for the purposes of determining the conformity of the state of health of a worker to the possibility of his performance of certain types of work.
2. The expert examination of occupational fitness is conducted by the medical commission of a medical organization with the involvement of specialist physicians according to the results of preliminary medical examinations and periodic medical examinations. According to the results of the expert examination of occupational fitness, the medical commission renders a medical conclusion on the fitness or unfitness of the worker for the performance of certain types of work.
3. The procedure for the conduct of the expert examination of occupational fitness, the form of the medical conclusion on fitness or unfitness for the performance of certain types of work are established by the authorized federal executive body.
4. The expert examination of the connection of a disease with the occupation is conducted for the purposes of establishing the cause-and-effect relationship of the disease with the professional activity.
5. The expert examination of the connection of a disease with the occupation is conducted by a specialized medical organization or a specialized structural subdivision of a medical organization in the field of occupational pathology upon the identification of an occupational disease. According to the results of the expert examination of the connection of a disease with the occupation, a medical conclusion on the presence or absence of an occupational disease is rendered.
6. The procedure for the conduct of the expert examination of the connection of a disease with the occupation and the form of the medical conclusion on the presence or absence of an occupational disease are established by the authorized federal executive body.

 

Article 64. Expert Examination of the Quality of Medical Care

1. The expert examination of the quality of medical care is conducted for the purposes of identifying violations in the provision of medical care, including the assessment of the timeliness of its provision, the correctness of the choice of methods of prevention, diagnosis, treatment and rehabilitation, the degree of achievement of the planned result.
2. The criteria for the assessment of the quality of medical care are formed by groups of diseases or states on the basis of the relevant procedures for the provision of medical care and clinical guidelines and are approved by the authorized federal executive body. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 25.12.2018 N 489-FL)
3. The expert examination of the quality of medical care provided within the framework of compulsory medical insurance programmes is conducted on the basis of the criteria for the assessment of the quality of medical care approved in accordance with Part 2 of this Article, in accordance with the legislation of the Russian Federation on compulsory medical insurance. (as amended by Federal Law of 25.12.2018 N 489-FL)
4. The expert examination of the quality of medical care, except for medical care provided in accordance with the legislation of the Russian Federation on compulsory medical insurance, is carried out in the procedure established by the authorized federal executive body on the basis of the criteria for the assessment of the quality of medical care approved in accordance with Part 2 of this Article. (as amended by Federal Law of 25.12.2018 N 489-FL)

 

Article 65. Medical Certification

1. The medical certification of a person is a set of methods of medical examination and medical studies aimed at confirming such a state of human health which entails the occurrence of legally significant consequences.
2. The types of medical certification are:

1) certification for the state of intoxication (alcoholic, narcotic or other toxic);

2) psychiatric certification;

3) certification for the presence of medical contraindications to driving a vehicle;

4) certification for the presence of medical contraindications to the possession of weapons;

5) other types of medical certification established by the legislation of the Russian Federation.

3. The financial support of medical certification is carried out in accordance with the legislation of the Russian Federation.
4. Medical certification is conducted in medical organizations in the procedure established by the authorized federal executive body.
5. Psychiatric certification is conducted in accordance with the legislation of the Russian Federation on psychiatric care and guarantees of the rights of citizens in its provision.

 

Chapter 8. MEDICAL MEASURES CARRIED OUT IN CONNECTION WITH THE DEATH OF A PERSON

 

Article 66. Determination of the Moment of Death of a Person and of the Termination of Resuscitation Measures

1. The moment of death of a person is the moment of the death of his brain or his biological death (irreversible demise of the person).
2. Brain death occurs upon the complete and irreversible cessation of all its functions, registered with a working heart and artificial lung ventilation.
3. The diagnosis of brain death is established by a konsilium of physicians in the medical organization in which the patient is located. The konsilium of physicians must include an anaesthesiologist-resuscitator and a neurologist having work experience in the specialty of not less than five years. The konsilium of physicians may not include specialists taking part in the removal and transplantation (grafting) of organs and (or) tissues. (as amended by Federal Law of 25.11.2013 N 317-FL)
4. The biological death of a person is established on the basis of the presence of early and (or) late cadaveric changes.
5. The pronouncement of the biological death of a person is carried out by a medical worker (a physician or a feldsher).
6. Resuscitation measures are terminated in the event of their being recognized as absolutely futile, namely:

1) upon the pronouncement of the death of a person on the basis of the death of the brain, including against the background of the ineffective application of the full set of resuscitation measures aimed at maintaining life;

2) in the event of the ineffectiveness of resuscitation measures aimed at the restoration of vital functions within thirty minutes;

3) in the absence of a heartbeat in a newborn after the expiry of ten minutes from the beginning of the conduct of resuscitation measures (artificial lung ventilation, cardiac massage, administration of medicinal products).

7. Resuscitation measures are not conducted:

1) in the state of clinical death (cessation of the vital functions of the human organism (blood circulation and respiration) of a potentially reversible nature against the background of the absence of signs of brain death) against the background of the progression of reliably established incurable diseases or incurable consequences of an acute trauma incompatible with life;

2) in the presence of signs of the biological death of a person.

8. The procedure for determining the moment of death of a person, including the criteria and procedure for establishing the death of a person, the procedure for the termination of resuscitation measures and the form of the protocol of the establishment of the death of a person are determined by the Government of the Russian Federation.

 

Article 67. Conduct of Pathologic-Anatomical Autopsies

1. Pathologic-anatomical autopsies are conducted by physicians of the relevant specialty for the purposes of obtaining data on the cause of death of a person and the diagnosis of the disease.
2. The procedure for the conduct of pathologic-anatomical autopsies is determined by the authorized federal executive body.
3. For religious reasons, if there is a written application of the spouse or a close relative (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother), and in their absence of other relatives or the legal representative of the deceased, or upon the expression of will of the deceased himself made by him during his lifetime, a pathologic-anatomical autopsy is not performed, except for cases of:

1) suspicion of violent death;

2) the impossibility of establishing the final clinical diagnosis of the disease that led to death and (or) the immediate cause of death;

3) the provision to the deceased patient by a medical organization of medical care in inpatient conditions for less than one day;

4) suspicion of an overdose or intolerance of medicinal products or diagnostic products;

5) death:

а) associated with the conduct of preventive, diagnostic, instrumental, anaesthesiological, resuscitation, therapeutic measures, during or after an operation of transfusion of blood and (or) its components;

б) from an infectious disease or upon suspicion of it;

в) from an oncological disease in the absence of histological verification of the tumour;

г) from a disease associated with the consequences of an environmental disaster;

д) of pregnant women, women in labour, puerperant women (including the last day of the postpartum period) and children aged up to twenty-eight days of life inclusive;

6) the birth of a dead child;

7) the necessity of a forensic medical study.

4. In the conduct of a pathologic-anatomical autopsy, histological, biochemical, microbiological and other necessary methods of study of individual organs, tissues of the deceased or their parts are an integral part of the diagnostic process for the purposes of identifying the causes of death of a person, the complications of the underlying disease and the concomitant disease, his state. The expression of will of the deceased expressed during his lifetime, or a written application of the spouse, a close relative (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother), and in their absence of other relatives or the legal representative of the deceased, on the conduct of such studies is not required.
5. The conclusion on the cause of death and the diagnosis of the disease is issued to the spouse, a close relative (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother), and in their absence to other relatives or the legal representative of the deceased, to law enforcement bodies, to the body exercising federal state control of the quality and safety of medical activity, and to the body exercising federal control of the quality and conditions of the provision of medical care, upon their demand. (as amended by Federal Law of 11.06.2021 N 170-FL)
6. The spouse, a close relative (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother), and in their absence other relatives or the legal representative of the deceased, are granted the right to invite a specialist physician (with his consent) to participate in the pathologic-anatomical autopsy.
7. The conclusion on the results of the pathologic-anatomical autopsy may be appealed in court by the spouse, a close relative (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother), and in their absence by another relative or the legal representative of the deceased, in the procedure established by the legislation of the Russian Federation.
8. A pathologic-anatomical autopsy is conducted with observance of a dignified attitude to the body of the deceased person and with the maximum preservation of its anatomical form.

 

Article 68. Use of the Body, Organs and Tissues of a Deceased Person

1. The body, organs and tissues of a deceased person may be used for medical (except for use for the purposes provided for by Article 47 of this Federal Law), scientific and educational purposes in the following cases: (as amended by Federal Law of 25.11.2013 N 317-FL)

1) if there is a written expression of will of the person made by him during his lifetime and notarially certified in the established procedure on the possibility of such use;

2) if the body has not been claimed after the death of the person due to the absence of his spouse, close relatives (children, parents, adopted children, adoptive parents, full brothers and full sisters, grandchildren, grandfather, grandmother), other relatives, legal representatives or other persons who have undertaken the duty to carry out the burial, in the procedure and within the terms established by the legislation of the Russian Federation on burial and funeral business.

2. The procedure and conditions for the transfer of an unclaimed body, organs and tissues of a deceased person for use for medical, scientific and educational purposes, the procedure for the use of an unclaimed body, organs and tissues of a deceased person for the said purposes, including the maximum term of their use, are established by the Government of the Russian Federation. After the expiry of the maximum term, the unclaimed body, organs and tissues of the deceased person are subject to burial in accordance with the legislation of the Russian Federation on burial and funeral business.

 

Article 68.1. Federal Register of Medical Documents on Death (as amended by Federal Law of 02.07.2021 N 358-FL)

1. For the purposes of the coordination of the activities of federal executive bodies, executive bodies of constituent entities of the Russian Federation, local self-government bodies, medical organizations of the state, municipal and private health care systems in the part of keeping records of data on the facts of death, its causes and the structure of mortality, the authorized federal executive body maintains, as part of the unified state information system in the sphere of health care, the Federal Register of Medical Documents on Death (hereinafter in this Article – the Federal Register), containing documents on death and documents on perinatal death generated in the form of an electronic document, and also data on the deceased person provided for by the form of the document on death or the form of the document on perinatal death, which are approved by the authorized federal executive body. (as amended by Federal Law of 08.08.2024 N 232-FL)
2. The procedure for the maintenance of the Federal Register, including the procedure for access to the data contained in it, the procedure and terms for the submission of data to the said register, is established by the Government of the Russian Federation.
3. The data included in the Federal Register are submitted by medical organizations, except for the data specified in Part 5 of this Article.
4. The Federal Register ensures the storage of documents on death and documents on perinatal death generated in the form of an electronic document. In the event of the issuance of a document on death or a document on perinatal death on paper, the data on the deceased person are entered into the Federal Register by the medical organization in the procedure and within the terms which are established by the Government of the Russian Federation.
5. If state information systems contain data on the deceased person, the formation and (or) collection of which are carried out by bodies of state power of the Russian Federation, management bodies of state extra-budgetary funds in accordance with their powers established by federal laws, the said data and (or) information making it possible to identify such data in state information systems are submitted by the bodies and organizations to the Federal Register in accordance with the procedure for the maintenance of the said register.
6. Documents on death and documents on perinatal death contained in the Federal Register which, in the cases determined by Federal Law of 15 November 1997 N 143-FL “On Acts of Civil Status”, are the basis for the state registration of death and the state registration of the birth of a child born dead, are transferred, for the purposes of the state registration of the said acts of civil status, to the Unified State Register of Records of Acts of Civil Status in the procedure and within the terms which are established by the Government of the Russian Federation.
7. The data on the deceased person contained in the Federal Register are transferred to the federal executive body exercising the functions of forming official statistical information on social, economic, demographic, environmental and other public processes in the Russian Federation (its territorial bodies) in the procedure and within the terms which are established by the Government of the Russian Federation.

 

Chapter 9. MEDICAL WORKERS AND PHARMACEUTICAL WORKERS, MEDICAL ORGANIZATIONS

To normative legal acts of the RF establishing mandatory requirements and provided for by Article 69 of this document (as worded by Federal Law of 14.07.2022 N 275-FL), the provisions of Part 1 of Article 3 of Federal Law of 31.07.2020 N 247-FL “On Mandatory Requirements in the Russian Federation” do not apply (Clause 4 of Article 3 of Federal Law of 14.07.2022 N 275-FL).

 

Article 69. Right to Carry Out Medical Activity and Pharmaceutical Activity

1. The right to carry out medical activity in the Russian Federation belongs to persons who have received medical or other education in Russian organizations carrying out educational activity and who have undergone the accreditation of a specialist. (as amended by Federal Law of 14.07.2022 N 275-FL)
2. The right to carry out pharmaceutical activity in the Russian Federation belongs to:

1) persons who have received pharmaceutical education in Russian organizations carrying out educational activity and who have undergone the accreditation of a specialist; (as amended by Federal Law of 14.07.2022 N 275-FL)

2) persons having the right to carry out medical activity and who have received additional professional education in the part of retail trade in medicinal products, provided that they work in separate subdivisions of medical organizations having a licence to carry out pharmaceutical activity and located in rural settlements in which there are no pharmacy organizations. (as amended by Federal Law of 08.08.2024 N 323-FL)

2.1. Pedagogical and scientific workers having a specialist certificate or having undergone the accreditation of a specialist, carrying out the practical training of students in accordance with Article 82 of Federal Law of 29 December 2012 N 273-FL “On Education in the Russian Federation”, and also scientific workers having a specialist certificate or having undergone the accreditation of a specialist, carrying out scientific research in the sphere of health protection, are entitled to carry out medical activity. The rights, duties and responsibility of medical workers extend to pedagogical and scientific workers when they carry out medical activity. (as amended by Federal Laws of 29.12.2015 N 389-FL, of 02.07.2021 N 312-FL)

3. The accreditation of a specialist is a procedure for determining the conformity of a person who has received medical, pharmaceutical or other education to the requirements for carrying out medical activity in a certain medical specialty or pharmaceutical activity. The accreditation of a specialist is conducted by an accreditation commission upon the completion of his mastering of professional educational programmes of medical education or pharmaceutical education at least once every five years. The accreditation commission is formed by the authorized federal executive body with the participation of the professional non-commercial organizations specified in Article 76 of this Federal Law. The regulations on the accreditation of specialists, including the types of accreditation of specialists (primary accreditation of a specialist, primary specialized accreditation of a specialist, periodic accreditation of a specialist) and the categories of persons in respect of whom a specific type of accreditation of a specialist is conducted, the procedure for the issuance of a certificate of accreditation of a specialist on paper, the form of the certificate of accreditation of a specialist on paper and the technical requirements for it, the procedure for the issuance of an extract on the presence in the unified state information system in the sphere of health care of data confirming the fact of the said person having undergone the accreditation of a specialist (hereinafter – extract on undergoing accreditation), are approved by the authorized federal executive body. For the purposes of ensuring the protection of information constituting a state secret, the Government of the Russian Federation establishes the specifics of the conduct of the accreditation of a specialist and of recognizing him as having undergone accreditation in respect of certain categories of persons. (as amended by Federal Laws of 29.12.2015 N 389-FL, of 02.07.2021 N 312-FL, of 17.11.2025 N 424-FL)

3.1. A person is considered to have undergone the accreditation of a specialist from the moment of the entry of the data on the person’s undergoing the accreditation of a specialist into the unified state information system in the sphere of health care, except for certain categories of persons in respect of whom the Government of the Russian Federation establishes the specifics of the conduct of the accreditation of a specialist and of recognizing him as having undergone accreditation, in accordance with Part 3 of this Article. The data on the person’s undergoing the accreditation of a specialist are entered into the unified state information system in the sphere of health care within the framework of the maintenance of personalized records of persons participating in the carrying out of medical activity, in accordance with Articles 92 and 93 of this Federal Law. (as amended by Federal Law of 02.07.2021 N 312-FL)

3.2. Upon the application of a person who has undergone the accreditation of a specialist, he is issued a certificate of accreditation of a specialist on paper and (or) an extract on undergoing accreditation. The certificate of accreditation of a specialist and the extract on undergoing accreditation have equal legal force in confirming the fact of the person having undergone the accreditation of a specialist. (as amended by Federal Law of 02.07.2021 N 312-FL)

The operation of the provisions of Part 3.3 of Article 69 does not extend to persons who, before 01.03.2026, completed training under basic professional educational programmes or for the first time underwent the primary accreditation of a specialist, the primary specialized accreditation of a specialist in the relevant specialty (Part 3 of Article 4 of Federal Law of 17.11.2025 N 424-FL).

3.3. In respect of persons who have received medical education under basic professional educational programmes in specialties (fields of training) according to the list provided for by Part 3.4 of this Article and who have for the first time undergone the primary accreditation of a specialist, the primary specialized accreditation of a specialist in the relevant specialty, mentoring in the sphere of health care is carried out for not more than three years. During the period of mentoring in the sphere of health care, persons who have received medical education under a contract on targeted training carry out medical activity at their main place of work in the organizations in which the said persons are employed in accordance with such contract; other persons carry out medical activity at their main place of work in medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens. Upon the end of the period of mentoring in the sphere of health care, the persons in respect of whom this mentoring was carried out are subject to the periodic accreditation of a specialist. (as amended by Federal Law of 17.11.2025 N 424-FL)

3.4. The list of specialties (fields of training) after the completion of training in which the operation of Part 3.3 of this Article extends to the persons specified in the said Part, the terms within which mentoring in the sphere of health care must be carried out depending on the specialty (field of training) and (or) the location of the organization in which medical activity is carried out, the regulations on mentoring in the sphere of health care are established by the authorized federal executive body. (as amended by Federal Law of 17.11.2025 N 424-FL)

3.5. If mentoring in the sphere of health care was not carried out or was carried out for less than the term established in accordance with Part 3.4 of this Article, upon the expiry of the term of validity of the primary accreditation of a specialist, the primary specialized accreditation of a specialist in respect of the persons specified in Part 3.3 of this Article, the primary accreditation of a specialist, the primary specialized accreditation of a specialist are conducted again, the specifics of which may be established by the regulations on the accreditation of specialists approved in accordance with Part 3 of this Article. In respect of the said persons, mentoring is also carried out in accordance with Part 3.3 of this Article until the established total term of mentoring is reached. (as amended by Federal Law of 17.11.2025 N 424-FL)

3.6. Persons in respect of whom mentoring in the sphere of health care in accordance with Part 3.3 of this Article must not be carried out undergo the periodic accreditation of a specialist within the term established by Part 3 of this Article. (as amended by Federal Law of 17.11.2025 N 424-FL)

4. Persons having medical or pharmaceutical education who have not worked in their specialty for more than five years may be admitted to carrying out medical activity or pharmaceutical activity in accordance with the specialty received after undergoing training under additional professional programmes (advanced training, professional retraining) and undergoing the accreditation of a specialist. (as amended by Federal Laws of 02.07.2013 N 185-FL, of 29.12.2015 N 389-FL)
5. Persons who have not completed mastering the educational programmes of higher medical or higher pharmaceutical education in Russian organizations carrying out educational activity, and persons with higher medical or higher pharmaceutical education received in Russian organizations carrying out educational activity, may be admitted to carrying out medical activity or pharmaceutical activity in the positions of specialists with secondary medical or secondary pharmaceutical education in the procedure established by the authorized federal executive body. (as amended by Federal Law of 14.07.2022 N 275-FL)

To normative legal acts of the Russian Federation establishing mandatory requirements and provided for by Article 69 (as worded by Federal Law of 04.08.2023 N 462-FL), the provisions of Parts 1 and 3 of Article 3 and of Article 11 of Federal Law of 31.07.2020 N 247-FL “On Mandatory Requirements in the Russian Federation” do not apply (Clause 2 of Article 2 of Federal Law of 04.08.2023 N 462-FL).

5.1. Persons studying under residency programmes in one of the specialties of the enlarged group of specialties “Clinical Medicine” may be admitted to carrying out medical activity in the positions of trainee physicians in the procedure and on the conditions established by the authorized federal executive body. (as amended by Federal Law of 04.08.2023 N 462-FL)

6. Persons who have received medical, pharmaceutical or other education in foreign organizations carrying out educational activity are admitted to carrying out medical activity or pharmaceutical activity after the recognition in the Russian Federation of the education and (or) qualification received in the procedure established by the legislation on education, the establishment by the federal executive body exercising the functions of control and supervision in the sphere of health protection, in the procedure approved by it, of the conformity of the education and (or) qualification received to the qualification requirements for medical and pharmaceutical workers approved by the authorized federal executive body, and undergoing the accreditation of a specialist, unless otherwise provided for by international treaties of the Russian Federation. (as amended by Federal Law of 14.07.2022 N 275-FL)

6.1. Persons who have not completed mastering the educational programmes of higher medical or higher pharmaceutical education in foreign organizations carrying out educational activity, and persons with higher medical or higher pharmaceutical education received in foreign organizations carrying out educational activity, may be admitted to carrying out medical activity or pharmaceutical activity in the positions of specialists with secondary medical or secondary pharmaceutical education in the procedure established by the authorized federal executive body. (as amended by Federal Law of 14.07.2022 N 275-FL)

7. Persons unlawfully engaged in medical activity and pharmaceutical activity bear criminal liability in accordance with the legislation of the Russian Federation.

 

Article 70. Attending Physician

1. The attending physician is appointed by the head of the medical organization (subdivision of the medical organization) or is chosen by the patient taking into account the consent of the physician. In the event of a demand of the patient for the replacement of the attending physician, the head of the medical organization (subdivision of the medical organization) must assist the patient in choosing another physician in the procedure established by the authorized federal executive body.
2. The attending physician organizes the timely qualified examination and treatment of the patient, provides information on the state of his health, upon the demand of the patient or his legal representative invites specialist physicians for consultations, where necessary convenes a konsilium of physicians for the purposes established by Part 4 of Article 47 of this Federal Law. The recommendations of the consultants are implemented only in agreement with the attending physician, except for cases of the provision of emergency medical care.
3. The attending physician, in agreement with the relevant official (head) of the medical organization (subdivision of the medical organization), may refuse the observation of the patient and his treatment, and also notify in writing of the refusal to conduct an artificial termination of pregnancy, if the refusal does not directly threaten the life of the patient and the health of others. In the event of the refusal of the attending physician of the observation of the patient and the treatment of the patient, and also in the event of notification in writing of the refusal to conduct an artificial termination of pregnancy, the official (head) of the medical organization (subdivision of the medical organization) must organize the replacement of the attending physician.
4. The attending physician, when recommending to the patient a medicinal product, a medical device, a specialized therapeutic nutrition product or a breast milk substitute, is obliged to inform the patient of the possibility of his receiving the relevant medicinal product, medical device, specialized therapeutic nutrition product or breast milk substitute without charging a fee in accordance with the legislation of the Russian Federation.
5. The attending physician establishes the diagnosis, which is a medical conclusion on the disease (state) of the patient, including that which was the cause of death of the patient, based on a comprehensive examination of the patient and drawn up with the use of medical terms.
6. The diagnosis, as a rule, includes data on the underlying disease or state, concomitant diseases or states, and also on complications caused by the underlying disease and the concomitant disease.
7. Certain functions of the attending physician for the direct provision of medical care to the patient during the period of observation of him and his treatment, including for the prescription and application of medicinal products, including narcotic medicinal products and psychotropic medicinal products, may be entrusted by the head of the medical organization, in the organization of the provision of primary health care and emergency medical care, to a feldsher, a midwife in the procedure established by the authorized federal executive body.

 

Article 71. Physician’s Oath

1. Persons who have completed mastering the educational programme of higher medical education, upon receiving the document on education and qualification, take the physician’s oath of the following content: (as amended by Federal Law of 02.07.2013 N 185-FL)

“Receiving the high title of physician and commencing professional activity, I solemnly swear:

to honestly perform my medical duty, to devote my knowledge and skills to the prevention and treatment of diseases, the preservation and strengthening of human health;

to always be ready to provide medical care, to keep medical secrecy, to treat the patient attentively and caringly, to act exclusively in his interests irrespective of sex, race, nationality, language, origin, property and official status, place of residence, attitude to religion, convictions, membership in public associations, and also of other circumstances;

to show the highest respect for human life, never to resort to the carrying out of euthanasia;

to keep gratitude and respect for my teachers, to be demanding and fair to my students, to contribute to their professional growth;

to treat colleagues benevolently, to turn to them for help and advice if the interests of the patient so require, and myself never to refuse colleagues help and advice;

to constantly improve my professional skill, to preserve and develop the noble traditions of medicine.”.

2. The physician’s oath is taken in a solemn atmosphere.

 

Article 72. Rights of Medical Workers and Pharmaceutical Workers and Measures for Their Stimulation

1. Medical workers and pharmaceutical workers have the right to the basic guarantees provided for by labour legislation and other normative legal acts of the Russian Federation, including to:

1) the creation by the head of the medical organization of appropriate conditions for the performance by the worker of his labour duties, including the provision of the necessary equipment, in the procedure determined by the legislation of the Russian Federation;

2) professional training, retraining and advanced training at the expense of the employer in accordance with the labour legislation of the Russian Federation;

3) professional retraining at the expense of the employer or other funds provided for these purposes by the legislation of the Russian Federation, in the event of the impossibility of performing labour duties due to the state of health and upon the dismissal of workers in connection with a reduction of headcount or staff, in connection with the liquidation of the organization;

4) undergoing attestation for receiving a qualification category in the procedure and within the terms determined by the authorized federal executive body, and also to the differentiation of remuneration of labour according to the results of attestation;

5) the stimulation of labour in accordance with the level of qualification, the specifics and complexity of the work, the volume and quality of labour, and also the specific results of activity;

6) the creation of professional non-commercial organizations;

7) insurance of the risk of their professional liability.

2. The Government of the Russian Federation, bodies of state power of constituent entities of the Russian Federation and local self-government bodies are entitled to establish additional guarantees and measures of social support for medical workers, including the persons specified in Part 3.3 of Article 69 of this Federal Law, and pharmaceutical workers at the expense of, respectively, the budget allocations of the federal budget, the budget allocations of the budgets of constituent entities of the Russian Federation and local budgets. (as amended by Federal Law of 04.08.2026 N 329-FL)
3. Information on the establishment of additional guarantees and measures of social support for medical workers and pharmaceutical workers is placed in the state information system “Unified Centralized Digital Platform in the Social Sphere”. The placement and receipt of the said information in the state information system “Unified Centralized Digital Platform in the Social Sphere” are carried out in accordance with Federal Law of 17 July 1999 N 178-FL “On State Social Assistance”. (as amended by Federal Laws of 07.03.2018 N 56-FL, of 25.12.2023 N 635-FL)

 

Article 73. Duties of Medical Workers and Pharmaceutical Workers

1. Medical workers and pharmaceutical workers carry out their activity in accordance with the legislation of the Russian Federation, guided by the principles of medical ethics and deontology.
2. Medical workers are obliged to:

1) provide medical care in accordance with their qualification, job descriptions, service and job duties;

2) observe medical secrecy;

3) improve their professional knowledge and skills by means of training under additional professional programmes in educational and scientific organizations in the procedure and within the terms established by the authorized federal executive body; (as amended by Federal Law of 02.07.2013 N 185-FL)

4) prescribe medicinal products in the procedure established by the authorized federal executive body; (as amended by Federal Law of 29.07.2017 N 242-FL)

5) report to the authorized official of the medical organization the information provided for by Part 3 of Article 64 of Federal Law of 12 April 2010 N 61-FL “On the Circulation of Medicines” and Part 3 of Article 96 of this Federal Law.

3. Pharmaceutical workers bear the duties provided for by Clauses 2, 3 and 5 of Part 2 of this Article.

 

Article 74. Restrictions Imposed on Medical Workers and Pharmaceutical Workers in the Carrying Out of Their Professional Activity

1. Medical workers and heads of medical organizations are not entitled to:

1) accept from organizations engaged in the development, production and (or) sale of medicinal products, biologically active additives, medical devices, organizations having rights to use the trade name of a medicinal product, organizations of wholesale trade in medicines, pharmacy organizations (their representatives, other natural and legal persons carrying out their activity on behalf of these organizations) (hereinafter, respectively, – company, company representative) gifts, monetary funds (except for remuneration under contracts in the conduct of clinical studies of medicinal products, clinical trials of medical devices, remuneration related to the carrying out by a medical worker of pedagogical and (or) scientific activity), including for paying for entertainment, recreation, travel to the place of recreation, and also to participate in entertainment events conducted at the expense of companies, company representatives; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 07.06.2025 N 150-FL)

2) conclude with a company, a company representative agreements on the prescription or recommendation to patients of medicinal products, biologically active additives, medical devices (except for contracts on the conduct of clinical studies of medicinal products, clinical trials of medical devices); (as amended by Federal Law of 07.06.2025 N 150-FL)

3) receive from a company, a company representative samples of medicinal products, biologically active additives, medical devices for handing to patients (except for cases related to the conduct of clinical studies of medicinal products, clinical trials of medical devices); (as amended by Federal Law of 07.06.2025 N 150-FL)

4) provide, when prescribing a course of treatment to a patient, unreliable and (or) incomplete information on the medicinal products, biologically active additives, medical devices used, including concealing data on the presence in circulation of analogous medicinal products, biologically active additives, medical devices; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 07.06.2025 N 150-FL)

5) receive representatives of companies, except for cases related to the conduct of clinical studies of medicinal products, clinical trials of medical devices, participation, in the procedure established by the administration of the medical organization, in meetings of medical workers and other events aimed at raising their professional level or at providing information related to the carrying out of the monitoring of the safety of medicinal products and the monitoring of the safety of medical devices; (as amended by Federal Law of 25.11.2013 N 317-FL)

6) issue prescriptions for medicinal products, medical devices on blanks containing information of an advertising nature, and also on prescription blanks on which the name of a medicinal product, a medical device has been pre-printed. (as amended by Federal Law of 29.07.2017 N 242-FL)

2. Pharmaceutical workers and heads of pharmacy organizations are not entitled to:

1) accept gifts, monetary funds, including for paying for entertainment, recreation, travel to the place of recreation, and to take part in entertainment events conducted at the expense of a company, a company representative;

2) receive from a company, a company representative samples of medicinal products, medical devices for handing to the population;

3) conclude with a company, a company representative agreements on offering certain medicinal products, medical devices to the population;

4) provide to the population unreliable and (or) incomplete information on the availability of medicinal products, including medicinal products having the same international non-proprietary name, medical devices, including concealing information on the availability of medicinal products and medical devices having a lower price. (as amended by Federal Law of 25.11.2013 N 317-FL)

3. For violations of the requirements of this Article, medical and pharmaceutical workers, heads of medical organizations and heads of pharmacy organizations, and also companies, company representatives bear liability provided for by the legislation of the Russian Federation.

 

Article 75. Settlement of a Conflict of Interest in the Carrying Out of Medical Activity and Pharmaceutical Activity, and also in the Development and Consideration of Clinical Guidelines (as amended by Federal Law of 25.12.2018 N 489-FL)

1. A conflict of interest is a situation in which a medical worker or a pharmaceutical worker in the carrying out of their professional activity, or a member of a medical professional non-commercial organization participating in the development of clinical guidelines, or a member of the scientific and practical council has a personal interest in receiving, personally or through a company representative, a material benefit or another advantage which influences or may influence the proper performance by them of professional duties, and also of other duties, including those related to the development and consideration of clinical guidelines, as a result of a contradiction between the personal interest of the said persons and the interests of patients. (as amended by Federal Law of 25.12.2018 N 489-FL)
2. In the event of the occurrence of a conflict of interest, a medical worker or a pharmaceutical worker is obliged to inform thereof in writing the head of the medical organization or the head of the pharmacy organization in which he works, and an individual entrepreneur carrying out medical activity or pharmaceutical activity is obliged to inform of the occurrence of a conflict of interest the federal executive body authorized by the Government of the Russian Federation. (as amended by Federal Law of 25.11.2013 N 317-FL)
3. The head of a medical organization or the head of a pharmacy organization, within seven days from the day when he became aware of the conflict of interest, is obliged to notify thereof in writing the federal executive body authorized by the Government of the Russian Federation. (as amended by Federal Law of 25.11.2013 N 317-FL)
4. For the settlement of a conflict of interest, the federal executive body authorized by the Government of the Russian Federation forms a commission for the settlement of conflicts of interest. (as amended by Federal Law of 25.11.2013 N 317-FL)
5. The regulations on the commission for the settlement of conflicts of interest are approved by the authorized federal executive body. The composition of the commission for the settlement of conflicts of interest is formed taking into account the exclusion of the possibility of the occurrence of a conflict of interest which could influence the decisions taken by the said commission.
6. A member of a medical professional non-commercial organization participating in the development of clinical guidelines, a member of the scientific and practical council are obliged to inform in writing the authorized federal executive body of the occurrence of a conflict of interest or of the existence of circumstances capable of leading to a conflict of interest. (as amended by Federal Law of 25.12.2018 N 489-FL)
7. In the event of the occurrence of a conflict of interest, and also of the non-submission or untimely submission to the authorized federal executive body of information on the existence of circumstances capable of leading to a conflict of interest, or the submission of unreliable information on the existence of such circumstances, members of a medical professional non-commercial organization, in the procedure established by the authorized federal executive body, are removed from further participation in the activity of developing and endorsing clinical guidelines, and the decision in respect of a proposal adopted for inclusion in a draft clinical guideline with their participation is subject to review in the procedure established by Parts 4, 7, 9 and 11 of Article 37 of this Federal Law. (as amended by Federal Law of 25.12.2018 N 489-FL)
8. In the event of the occurrence of a conflict of interest, and also of the non-submission or untimely submission to the authorized federal executive body of information on the existence of circumstances capable of leading to a conflict of interest, or the submission of unreliable information on the existence of such circumstances, members of the scientific and practical council, in the procedure established by the authorized federal executive body, are removed from further participation in the activity of considering, approving and revising clinical guidelines. (as amended by Federal Law of 25.12.2018 N 489-FL)

 

Article 76. Professional Non-Commercial Organizations Created by Medical Workers and Pharmaceutical Workers

1. For the purposes of realizing and protecting the rights of medical workers and pharmaceutical workers, developing medical activity and pharmaceutical activity, assisting scientific research, resolving other matters related to the professional activity of medical workers and pharmaceutical workers, the said workers have the right to create, on a voluntary basis, professional non-commercial organizations, which may be formed in accordance with the criteria of:

1) belonging to medical workers or pharmaceutical workers;

2) belonging to a profession (physicians, nurses (feldshers), pharmacists, pharmacy technicians);

3) belonging to one medical specialty.

2. Professional non-commercial organizations may, in the procedure established by the legislation of the Russian Federation, take part in the development of norms and rules in the sphere of health protection, in resolving matters related to the violation of these norms and rules, in the development of procedures for the provision of medical care and standards of medical care, programmes of training and advanced training of medical workers and pharmaceutical workers, take part in the attestation of medical workers and pharmaceutical workers for their receiving qualification categories and in the conduct of the accreditation of specialists. Medical professional non-commercial organizations develop, including taking into account the results of clinical approbation, and endorse clinical guidelines in accordance with Article 37 of this Federal Law. (as amended by Federal Laws of 08.03.2015 N 55-FL, of 29.12.2015 N 389-FL, of 25.12.2018 N 489-FL)
3. Medical professional non-commercial organizations based on the personal membership of physicians and uniting not less than 25 percent of the total number of physicians in the territory of a constituent entity of the Russian Federation, along with the functions specified in Part 2 of this Article, are entitled to take part:

1) in the attestation of physicians for their receiving qualification categories;

2) in the conclusion of agreements on tariffs for medical services in the system of compulsory medical insurance and in the activities of compulsory medical insurance funds;

3) in the development of territorial programmes of state guarantees of the free provision of medical care to citizens;

4) in the formation of accreditation commissions and the conduct of the accreditation of specialists; (as amended by Federal Law of 29.12.2015 N 389-FL)

5) in the work of commissions for the assessment of the consequences of the adoption of a decision on the liquidation of a medical organization subordinate to an executive body of a constituent entity of the Russian Federation or a local self-government body, on the termination of the activities of its separate subdivision. (as amended by Federal Laws of 29.12.2017 N 465-FL, of 08.08.2024 N 232-FL)

4. If there are several medical professional non-commercial organizations in the territory of a constituent entity of the Russian Federation, in each of which the number of physicians exceeds 25 percent of their total number in the territory of the constituent entity of the Russian Federation, the functions provided for by Part 3 of this Article are carried out by the medical professional non-commercial organization having the largest number of members.
5. The exercise of certain functions in the sphere of health protection may be transferred by a federal law, in the procedure established by it, to medical professional non-commercial organizations, their associations (unions) which meet the criteria determined by the Government of the Russian Federation. The said organizations are entitled to take part in the activities of authorized federal executive bodies, compulsory medical insurance funds, and also in the development of programmes of state guarantees of the free provision of medical care to citizens in the procedure established by the legislation of the Russian Federation.

 

Article 77. – Has ceased to be in force. (as amended by Federal Law of 02.07.2013 N 185-FL)

 

Article 78. Rights of Medical Organizations

A medical organization has the right to:

1) submit to the founder proposals on the optimization of the provision of medical care to citizens;

2) participate in the provision of medical care to citizens of the Russian Federation in accordance with the programme of state guarantees of the free provision of medical care to citizens, including the basic programme of compulsory medical insurance;

3) issue medical conclusions, certificates, prescriptions for medicinal products and medical devices on paper and (or), with the consent of the patient or his legal representative, in the form of electronic documents with the use of the enhanced qualified electronic signature of the medical worker in the procedure established by the authorized federal executive body; (as amended by Federal Law of 29.07.2017 N 242-FL)

3.1) generate in the form of an electronic document or, in individual cases, issue in the form of a document on paper certificates of incapacity for work in the procedure established in accordance with the legislation of the Russian Federation on compulsory social insurance in case of temporary incapacity for work and in connection with maternity; (as amended by Federal Laws of 01.05.2017 N 86-FL, of 30.04.2021 N 126-FL (as amended on 26.05.2021)))

4) carry out scientific and (or) research activity, including conducting fundamental and applied scientific research;

5) create medical information systems containing data on patients, on the medical care provided to them, on the medical activity of medical organizations, in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data, and in observance of medical secrecy. (as amended by Federal Law of 29.07.2017 N 242-FL)

 

Article 79. Duties of Medical Organizations

1. A medical organization is obliged to:

1) provide medical care in emergency form to citizens;

2) organize and carry out medical activity in accordance with legislative and other normative legal acts of the Russian Federation, including the procedures for the provision of medical care, and taking into account the standards of medical care; (as amended by Federal Laws of 25.11.2013 N 317-FL, of 25.12.2018 N 489-FL)

2.1) ensure the provision of medical care by medical workers on the basis of clinical guidelines, and also create conditions ensuring the conformity of the medical care provided to the criteria for the assessment of the quality of medical care; (as amended by Federal Law of 25.12.2018 N 489-FL)

3) inform citizens of the possibility of receiving medical care within the framework of the programme of state guarantees of the free provision of medical care to citizens and the territorial programmes of state guarantees of the free provision of medical care to citizens;

4) observe medical secrecy, including the confidentiality of personal data used in medical information systems;

5) ensure the application of medicinal products, specialized therapeutic nutrition products, medical devices, disinfection, disinsection and deratization agents permitted for application in the Russian Federation;

6) provide patients with reliable information on the medical care provided, the effectiveness of methods of treatment, the medicinal products used and the medical devices;

7) inform citizens in an accessible form, including with the use of the “Internet” network, about the medical activity carried out and about the medical workers of medical organizations, about the level of their education and about their qualification, and also provide other information determined by the authorized federal executive body necessary for the conduct of an independent assessment of the quality of the conditions of the provision of services by medical organizations; (as amended by Federal Laws of 21.07.2014 N 256-FL, of 05.12.2017 N 392-FL)

8) ensure the professional training, retraining and advanced training of medical workers in accordance with the labour legislation of the Russian Federation;

9) inform internal affairs bodies, in the procedure established by the authorized federal executive bodies, in the cases established by Clause 5 of Part 4 of Article 13 of this Federal Law; (as amended by Federal Law of 22.12.2020 N 438-FL)

10) carry out insurance in case of causing harm to the life and (or) health of a patient in the provision of medical care in accordance with a federal law;

Clauses 11 and 12 of Part 1 of Article 79 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 2, 17 (Part 1), 21 (Part 1), 23 (Part 1), 24 (Part 1), 46 (Part 1) and 55 (Part 3), to the extent that, in the system of the current legal regulation, they do not provide for the specifics, necessary for the protection of the rights of citizens, of the maintenance, recording and storage of medical documentation generated upon the hospitalization of a citizen in a medical organization providing psychiatric care in inpatient conditions in an involuntary procedure, after a court has recognized such hospitalization as unlawful (Resolution of the Constitutional Court of the RF of 13.07.2022 N 31-П).

To normative legal acts of the Russian Federation establishing mandatory requirements and provided for by this document, (as worded by Federal Law of 04.08.2023 N 464-FL), the provisions of Parts 1 and 3 of Article 3 and of Article 11 of Federal Law of 31.07.2020 N 247-FL “On Mandatory Requirements in the Russian Federation” do not apply (Clause 2 of Article 3 of Federal Law of 04.08.2023 N 464-FL).

11) maintain medical documentation in the established procedure taking into account the specifics of the maintenance and use of medical documentation containing data on the provision to a person of psychiatric care in an involuntary procedure provided for by the legislation of the Russian Federation on psychiatric care, and submit reporting by the types, forms, within the terms and in the volume which are established by the authorized federal executive body; (as amended by Federal Law of 04.08.2023 N 464-FL)

Clauses 11 and 12 of Part 1 of Article 79 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 2, 17 (Part 1), 21 (Part 1), 23 (Part 1), 24 (Part 1), 46 (Part 1) and 55 (Part 3), to the extent that, in the system of the current legal regulation, they do not provide for the specifics, necessary for the protection of the rights of citizens, of the maintenance, recording and storage of medical documentation generated upon the hospitalization of a citizen in a medical organization providing psychiatric care in inpatient conditions in an involuntary procedure, after a court has recognized such hospitalization as unlawful (Resolution of the Constitutional Court of the RF of 13.07.2022 N 31-П).

To normative legal acts of the Russian Federation establishing mandatory requirements and provided for by this document, (as worded by Federal Law of 04.08.2023 N 464-FL), the provisions of Parts 1 and 3 of Article 3 and of Article 11 of Federal Law of 31.07.2020 N 247-FL “On Mandatory Requirements in the Russian Federation” do not apply (Clause 2 of Article 3 of Federal Law of 04.08.2023 N 464-FL).

12) ensure the recording and storage of medical documentation, including strict reporting forms, taking into account the specifics of the storage of medical documentation containing data on the provision to a person of psychiatric care in an involuntary procedure provided for by the legislation of the Russian Federation on psychiatric care; (as amended by Federal Law of 04.08.2023 N 464-FL)

13) carry out measures to reduce the risk of injuries and occupational diseases, introduce safe methods of collection of medical waste and ensure protection from injury by elements of medical devices;

14) ensure conditions for the conduct of an independent assessment of the quality of the conditions of the provision of services; (as amended by Federal Laws of 21.07.2014 N 256-FL, of 05.12.2017 N 392-FL)

15) provide relatives and other family members or legal representatives of the patient, and also clergymen, with the possibility of visiting him in the medical organization, including in its structural subdivision intended for intensive therapy and resuscitation measures, in accordance with the general requirements established by the authorized federal executive body in accordance with Clauses 19.1 and 19.2 of Part 2 of Article 14 of this Federal Law; (as amended by Federal Laws of 29.05.2019 N 119-FL, of 08.08.2024 N 290-FL)

16) ensure the provision of information to the unified state information system in the sphere of health care in accordance with the legislation of the Russian Federation. (as amended by Federal Law of 02.07.2021 N 313-FL)

17) carry out mentoring in respect of the persons specified in Part 3.3 of Article 69 of this Federal Law. (as amended by Federal Law of 17.11.2025 N 424-FL)

2. Medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens, along with the duties provided for by Part 1 of this Article, are also obliged to:

1) provide patients with information on the procedure, scope and conditions of the provision of medical care in accordance with the programme of state guarantees of the free provision of medical care to citizens;

2) ensure the provision of medical care to citizens within the framework of the programme of state guarantees of the free provision of medical care to citizens and the territorial programmes of state guarantees of the free provision of medical care to citizens;

3) ensure the conduct of preventive measures aimed at the prevention of risk factors for the development of diseases and at their early detection;

4) carry out the promotion of a healthy lifestyle and the sanitary and hygienic education of the population.

 

Article 79.1. Independent Assessment of the Quality of the Conditions of the Provision of Services by Medical Organizations (as amended by Federal Laws of 21.07.2014 N 256-FL, of 05.12.2017 N 392-FL)

1. The independent assessment of the quality of the conditions of the provision of services by medical organizations is one of the forms of public control and is conducted for the purposes of providing citizens with information on the quality of the conditions of the provision of services by medical organizations, and also for the purposes of increasing the quality of their activity. The independent assessment of the quality of the conditions of the provision of services by medical organizations is not carried out for the purposes of control of the quality and safety of medical activity, and also of the expert examination and control of the quality of medical care. (as amended by Federal Law of 05.12.2017 N 392-FL)
2. The independent assessment of the quality of the conditions of the provision of services by medical organizations provides for the assessment of the conditions of the provision of services according to such general criteria as the openness and accessibility of information on the medical organization; the comfort of the conditions of the provision of medical services, including the waiting time for the provision of a medical service; the goodwill, courtesy of the workers of the medical organization; satisfaction with the conditions of the provision of services, and also the accessibility of medical services for disabled persons. (as amended by Federal Law of 05.12.2017 N 392-FL)
3. The independent assessment of the quality of the conditions of the provision of services by medical organizations is carried out in accordance with the provisions of this Article. In the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations, publicly available information on medical organizations placed, among other things, in the form of open data is used. (as amended by Federal Law of 05.12.2017 N 392-FL)
4. For the purposes of creating conditions for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations: (as amended by Federal Law of 05.12.2017 N 392-FL)

1) the Public Chamber of the Russian Federation, upon the appeal of the authorized federal executive body, not later than within a month from the day of receipt of the said appeal, forms from among representatives of all-Russian public organizations created for the purposes of protecting the rights and interests of citizens, all-Russian public associations of disabled persons, a public council for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens, the founder of which is the Russian Federation, and approves its composition. The Public Chamber of the Russian Federation informs the authorized federal executive body of the composition of the public council for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations created at this body. The list of types of medical organizations in accordance with the nomenclature of medical organizations in respect of which the independent assessment of the quality of the conditions of the provision of services by them is not conducted is approved by the authorized federal executive body with preliminary discussion at the said public council on the independent assessment of quality; (as amended by Federal Law of 05.12.2017 N 392-FL)

2) the public chambers of constituent entities of the Russian Federation, upon the appeal of bodies of state power of constituent entities of the Russian Federation, not later than within a month from the day of receipt of the said appeal, form from among representatives of public organizations created for the purposes of protecting the rights and interests of citizens, public associations of disabled persons, public councils for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens located in the territories of constituent entities of the Russian Federation, except for the medical organizations specified in Clause 1 of this Part and medical organizations in respect of which the independent assessment is conducted by public councils created at local self-government bodies, and approve their composition. The public chambers of constituent entities of the Russian Federation inform the bodies of state power of constituent entities of the Russian Federation of the composition of the public councils for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations created at these bodies; (as amended by Federal Law of 05.12.2017 N 392-FL)

3) the public chambers (councils) of municipal formations, in the event of the transfer of the powers of bodies of state power of constituent entities of the Russian Federation in the sphere of health protection in accordance with Part 2 of Article 16 of this Federal Law, upon the appeal of local self-government bodies of municipal districts, municipal okrugs, urban okrugs, are entitled to form from among representatives of public organizations created for the purposes of protecting the rights and interests of citizens, public associations of disabled persons, public councils for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens located in the territories of municipal formations, except for the medical organizations specified in Clauses 1 and 2 of this Part, and to approve their composition. The public chambers (councils) of municipal formations inform local self-government bodies of the composition of the public councils for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations created at these bodies. (as amended by Federal Laws of 05.12.2017 N 392-FL, of 26.05.2021 N 152-FL)

5. Indicators characterizing the general criteria for the assessment of the quality of the conditions of the provision of services by medical organizations in respect of which the independent assessment is conducted are established by the authorized federal executive body with preliminary discussion at the public council. (as amended by Federal Law of 05.12.2017 N 392-FL)
6. The composition of the public council for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations (hereinafter – the public council on the independent assessment of quality) is approved for a term of three years. When forming the public council on the independent assessment of quality for a new term, not less than one third of its composition is changed. The public council on the independent assessment of quality may not include representatives of bodies of state power and local self-government bodies, representatives of medical professional non-commercial organizations, and also heads (their deputies) and workers of medical organizations. In this regard, the public council on the independent assessment of quality involves in its work representatives of medical professional non-commercial organizations and the public chamber for the discussion and formation of the results of such assessment. The number of members of the public council on the independent assessment of quality may not be less than five persons. The members of the public council on the independent assessment of quality carry out their activity on a voluntary basis. Information on the activity of the relevant public council on the independent assessment of quality is subject to placement in the “Internet” network on the official website of, respectively, the authorized federal executive body, the executive body of the constituent entity of the Russian Federation, the local self-government body. (as amended by Federal Laws of 05.12.2017 N 392-FL, of 08.08.2024 N 232-FL)
7. The regulations on the public council for the conduct of the independent assessment of quality are approved by the body of state power or the local self-government body at which the said public council has been created. (as amended by Federal Law of 05.12.2017 N 392-FL)
8. The independent assessment of the quality of the conditions of the provision of services by medical organizations is conducted by the public councils on the independent assessment of quality not more often than once a year and not less often than once every three years in respect of one and the same medical organization. (as amended by Federal Law of 05.12.2017 N 392-FL)
9. Public councils on the independent assessment of quality: (as amended by Federal Law of 05.12.2017 N 392-FL)

1) determine the lists of medical organizations which participate in the implementation of the programme of state guarantees of the free provision of medical care to citizens and in respect of which the independent assessment of the quality of the conditions of the provision of services by these organizations is conducted; (as amended by Federal Law of 05.12.2017 N 392-FL)

2) take part in the consideration of draft documentation on the procurement of works, services, and also of draft state, municipal contracts concluded by the authorized federal executive body, bodies of state power of constituent entities of the Russian Federation or local self-government bodies with the organization which carries out the collection and generalization of information on the quality of the conditions of the provision of services by medical organizations (hereinafter – the operator); (as amended by Federal Law of 05.12.2017 N 392-FL)

3) clause has ceased to be in force. (as amended by Federal Law of 05.12.2017 N 392-FL)

4) carry out the independent assessment of the quality of the conditions of the provision of services by medical organizations taking into account the information submitted by the operator; (as amended by Federal Law of 05.12.2017 N 392-FL)

5) submit, respectively, to the authorized federal executive body, bodies of state power of constituent entities of the Russian Federation, local self-government bodies the results of the independent assessment of the quality of the conditions of the provision of services by medical organizations, and also proposals on improving their activity. (as amended by Federal Law of 05.12.2017 N 392-FL)

10. The conclusion of state, municipal contracts for the performance of works, the provision of services for the collection and generalization of information on the quality of the conditions of the provision of services by medical organizations is carried out in accordance with the legislation of the Russian Federation on the contract system in the sphere of procurement of goods, works, services for ensuring state and municipal needs. The authorized federal executive body, bodies of state power of constituent entities of the Russian Federation, local self-government bodies, according to the results of the conclusion of state, municipal contracts, execute a decision on the determination of the operator responsible for the collection and generalization of information on the quality of the conditions of the provision of services by medical organizations, and also, where necessary, provide the operator with publicly available information on the activity of these organizations formed in accordance with state and departmental statistical reporting (if it is not placed on the official website of the organization). (as amended by Federal Law of 05.12.2017 N 392-FL)
11. The information on the results of the independent assessment of the quality of the conditions of the provision of services by medical organizations received, respectively, by the authorized federal executive body, bodies of state power of constituent entities of the Russian Federation, local self-government bodies is subject to mandatory consideration by the said bodies within one month from the date of its receipt and is taken into account by them in developing measures for improving the activity of medical organizations and assessing the activity of their heads. (as amended by Federal Law of 05.12.2017 N 392-FL)
12. Information on the results of the independent assessment of the quality of the conditions of the provision of services by medical organizations is placed, respectively: (as amended by Federal Law of 05.12.2017 N 392-FL)

1) by the authorized federal executive body on the official website for placing information on state and municipal institutions in the “Internet” network;

2) by bodies of state power of constituent entities of the Russian Federation and local self-government bodies on their official websites and on the official website for placing information on state and municipal institutions in the “Internet” network.

13. The composition of the information on the results of the independent assessment of the quality of the conditions of the provision of services by medical organizations, including uniform requirements for such information, and the procedure for its placement on the official website for placing information on state and municipal institutions in the “Internet” network are determined by the federal executive body authorized by the Government of the Russian Federation. (as amended by Federal Law of 05.12.2017 N 392-FL)
14. The authorized federal executive body, bodies of state power of constituent entities of the Russian Federation, local self-government bodies and medical organizations ensure on their official websites in the “Internet” network the technical possibility for patients to express opinions on the quality of the conditions of the provision of services by medical organizations. (as amended by Federal Law of 05.12.2017 N 392-FL)
15. Information the provision of which is mandatory in accordance with the legislation of the Russian Federation is placed on the official websites of the authorized federal executive body, bodies of state power of constituent entities of the Russian Federation, local self-government bodies and medical organizations in the “Internet” network in accordance with the requirements for its content and form of provision established by the authorized federal executive body.
16. Control over compliance with the procedures for the conduct of the independent assessment of the quality of the conditions of the provision of services by medical organizations is carried out in accordance with the legislation of the Russian Federation. (as amended by Federal Law of 05.12.2017 N 392-FL)
17. The heads of medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens bear liability for failure to take measures to eliminate the deficiencies identified in the course of the independent assessment of the quality of the conditions of the provision of services by medical organizations, in accordance with labour legislation. In employment contracts with the heads of the said medical organizations, the results of the independent assessment of the quality of the conditions of the provision of services by medical organizations and of the fulfilment of the plan for the elimination of the deficiencies identified in the course of such assessment are included in the indicators of the effectiveness of the work of the heads. (as amended by Federal Law of 05.12.2017 N 392-FL)
18. The results of the independent assessment of the quality of the conditions of the provision of services by medical organizations are taken into account in assessing the effectiveness of the activity of the head of the authorized federal executive body, the highest officials of constituent entities of the Russian Federation and the heads of executive bodies of constituent entities of the Russian Federation, the heads of local self-government bodies. (as amended by Federal Laws of 05.12.2017 N 392-FL, of 08.08.2024 N 232-FL)

 

Article 79.2. National Medical Research Centres (as amended by Federal Law of 28.12.2025 N 515-FL)

1. For the purposes of the organizational and methodological support of medical activity, the introduction of modern methods of prevention, diagnosis, treatment of diseases and medical rehabilitation, the development of medical science and innovations in the sphere of health care, including the conduct of fundamental and applied scientific research and the carrying out of developments in the sphere of health protection, the status of a national medical research centre in a field of medical activity included in the list approved by the Government of the Russian Federation may be assigned by the Government of the Russian Federation to organizations subordinate to federal executive bodies and executive bodies of constituent entities of the Russian Federation and carrying out, as the main (statutory) type of activity, medical activity and scientific and (or) research activity.
2. The criteria which the organizations specified in Part 1 of this Article must meet for the assignment of the status of a national medical research centre, the procedure for the organization of the activities of national medical research centres, the procedure for the assignment and termination of the said status, including the grounds for its termination, are established by the Government of the Russian Federation.
3. For the purposes of the assignment to the organizations specified in Part 1 of this Article of the status of a national medical research centre, the federal executive body or the executive body of a constituent entity of the Russian Federation under whose jurisdiction such organizations are sends to the Government of the Russian Federation a petition, the form of which is approved by the Government of the Russian Federation. In the event of the assignment by the Government of the Russian Federation of the status of a national medical research centre to an organization subordinate to an executive body of a constituent entity of the Russian Federation, the executive body of the constituent entity of the Russian Federation organizes its activities in accordance with the procedure for the organization of the activities of national medical research centres established on the basis of Part 2 of this Article.
4. The financial support of the performance of the functions of national medical research centres is carried out at the expense of:

1) the budget allocations of the federal budget – in respect of national medical research centres subordinate to federal executive bodies;

2) the budget allocations of the budgets of constituent entities of the Russian Federation – in respect of national medical research centres subordinate to executive bodies of constituent entities of the Russian Federation;

3) other sources not prohibited by the legislation of the Russian Federation.

 

Chapter 10. PROGRAMME OF STATE GUARANTEES OF THE FREE PROVISION OF MEDICAL CARE TO CITIZENS

 

Article 80. Programme of State Guarantees of the Free Provision of Medical Care to Citizens

1. Within the framework of the programme of state guarantees of the free provision of medical care to citizens (except for medical care provided within the framework of clinical approbation), the following are provided: (as amended by Federal Law of 08.03.2015 N 55-FL)

1) primary health care, including pre-medical, medical and specialized;

2) specialized medical care, high-tech medical care, which is part of specialized medical care; (as amended by Federal Law of 25.11.2013 N 317-FL)

3) emergency medical care, including emergency specialized;

4) palliative medical care in medical organizations.

2. In the provision, within the framework of the programme of state guarantees of the free provision of medical care to citizens, of primary health care in day hospital conditions and in urgent form, specialized medical care, including high-tech, emergency medical care, including emergency specialized, palliative medical care in inpatient conditions, day hospital conditions and during home visits, citizens are provided with medicinal products for medical use included in the list of vital and essential medicinal products in accordance with Federal Law of 12 April 2010 N 61-FL “On the Circulation of Medicines”, and with medical devices included in the list, approved by the Government of the Russian Federation, of medical devices implanted into the human organism. The procedure for the formation of the list of medical devices implanted into the human organism is established by the Government of the Russian Federation. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 06.03.2019 N 18-FL)

2.1. The maximum selling prices of manufacturers and the maximum amounts of wholesale mark-ups to the actual selling prices for medical devices included in the list, approved by the Government of the Russian Federation, of medical devices implanted into the human organism in the provision of medical care within the framework of the programme of state guarantees of the free provision of medical care to citizens are subject to state regulation and are determined in the procedure established by the Government of the Russian Federation. The maximum selling prices of manufacturers and the maximum amounts of wholesale mark-ups to the actual selling prices for medical devices used for the preparation for implantation, the prevention of complications in surgical interventions, the delivery, fixation and extraction of medical devices implanted into the human organism, and included in the said list, are not subject to state regulation. (as amended by Federal Law of 03.07.2016 N 286-FL)

2.2. The authorized federal executive body exercising the functions of control and supervision in the sphere of health protection, in the procedure established by the Government of the Russian Federation: (as amended by Federal Law of 08.03.2015 N 33-FL)

1) carries out the state registration or re-registration of the maximum selling prices of manufacturers for medical devices included in the list, approved by the Government of the Russian Federation, of medical devices implanted into the human organism in the provision of medical care within the framework of the programme of state guarantees of the free provision of medical care to citizens; (as amended by Federal Law of 08.03.2015 N 33-FL)

2) maintains the state register of the maximum selling prices of manufacturers for medical devices included in the list, approved by the Government of the Russian Federation, of medical devices implanted into the human organism in the provision of medical care within the framework of the programme of state guarantees of the free provision of medical care to citizens. The said register contains the following data: (as amended by Federal Law of 08.03.2015 N 33-FL)

а) the name of the manufacturer of the medical device; (as amended by Federal Law of 08.03.2015 N 33-FL)

б) the name of the medical device; (as amended by Federal Law of 08.03.2015 N 33-FL)

в) the type of the medical device in the nomenclature classification of medical devices; (as amended by Federal Law of 08.03.2015 N 33-FL)

г) the registration number of the medical device; (as amended by Federal Law of 08.03.2015 N 33-FL)

д) the registered maximum selling price of the manufacturer for the medical device in roubles; (as amended by Federal Law of 08.03.2015 N 33-FL)

е) the date of the state registration of the maximum selling price of the manufacturer for the medical device. (as amended by Federal Law of 08.03.2015 N 33-FL)

3. In the provision of medical care within the framework of the programme of state guarantees of the free provision of medical care to citizens and the territorial programmes of state guarantees of the free provision of medical care to citizens, the following are not subject to payment at the expense of the personal funds of citizens:

1) the provision of medical services, the prescription and application of medicinal products included in the list of vital and essential medicinal products, medical devices included in the list of medical devices implanted into the human organism, blood components, therapeutic nutrition, including specialized therapeutic nutrition products, on medical indications on the basis of clinical guidelines and taking into account the standards of medical care; (as amended by Federal Law of 25.12.2018 N 489-FL)

2) the prescription and application on medical indications of medicinal products not included in the list of vital and essential medicinal products, medical devices not included in the list of medical devices implanted into the human organism – in cases of their replacement due to individual intolerance, on vital indications by decision of the medical commission; (as amended by Federal Law of 25.12.2018 N 489-FL)

3) the placement of patients in small wards (boxes) – on medical and (or) epidemiological indications established by the authorized federal executive body;

4) the creation of conditions of stay in inpatient conditions, including the provision of a sleeping place and food, in the case of joint stay of one of the parents, another family member or another legal representative in a medical organization in inpatient conditions with a child until he reaches the age of four years, with a child older than the said age – if there are medical indications, and with a disabled child who, in accordance with the individual programme of rehabilitation or habilitation of the disabled child issued according to the results of a medical and social expert examination, has limitations of the main categories of human life activity of the second and (or) third degrees of severity (limitations of the ability to self-care, and (or) independent movement, and (or) orientation, and (or) communication, and (or) learning, and (or) control of one’s behaviour) – irrespective of the age of the disabled child; (as amended by Federal Law of 14.07.2022 N 317-FL)

5) transport services when a medical worker accompanies a patient undergoing treatment in inpatient conditions for the purposes of fulfilling the procedures for the provision of medical care, clinical guidelines and taking into account the standards of medical care, in the event of the necessity of conducting diagnostic studies for such patient – in the absence of the possibility of their being conducted by the medical organization providing medical care to the patient; (as amended by Federal Law of 25.12.2018 N 489-FL)

6) the transportation and storage in a morgue of biological material received for study, of the corpses of patients who died in medical and other organizations, and the disposal of biological material;

7) medical activity related to the donation of human organs and tissues, including bone marrow and haematopoietic stem cells, for the purposes of transplantation (grafting), including the conduct of measures for the medical examination of the donor, the ensuring of the preservation of donor organs and tissues until their removal from the donor, the removal of donor organs and tissues, the storage and transportation of donor organs and tissues. (as amended by Federal Laws of 13.07.2015 N 271-FL, of 01.05.2022 N 129-FL)

4. The programme of state guarantees of the free provision of medical care to citizens is approved for a term of three years (for the next financial year and the planning period) by the Government of the Russian Federation, which annually considers the report on its implementation submitted by the authorized federal executive body.
5. Within the framework of the programme of state guarantees of the free provision of medical care to citizens, the following are established:

1) the list of types (including the list of types of high-tech medical care, which contains, among other things, the methods of treatment and the sources of financial support of high-tech medical care), forms and conditions of medical care the provision of which is carried out free of charge; (as amended by Federal Law of 25.11.2013 N 317-FL)

2) the list of diseases and states in which the provision of medical care is carried out free of charge;

3) the categories of citizens to whom the provision of medical care is carried out free of charge;

4) the basic programme of compulsory medical insurance in accordance with the legislation of the Russian Federation on compulsory medical insurance;

5) the average standards of the volume of medical care, the average standards of financial costs per unit of volume of medical care, the average per capita financing standards, and also the procedure and structure for the formation of tariffs for medical care and the methods of its payment;

6) the requirements for the territorial programmes of state guarantees of the free provision of medical care to citizens in the part of determining the procedure, the conditions of the provision of medical care, the criteria of the accessibility of medical care.

6. In the part of medical care the provision of which is carried out at the expense of the budget allocations of the federal budget, the programme of state guarantees establishes:

1) the list of types, forms and conditions of medical care the provision of which is carried out at the expense of the budget allocations of the federal budget;

2) the list of diseases, states in which the provision of medical care is carried out at the expense of the budget allocations of the federal budget;

3) the categories of citizens to whom the provision of medical care is carried out at the expense of the budget allocations of the federal budget;

4) the procedure and conditions of the provision of medical care at the expense of the budget allocations of the federal budget, the target values of the criteria of the accessibility of medical care.

7. The programme of state guarantees of the free provision of medical care to citizens is formed taking into account the procedures for the provision of medical care, standards of medical care, clinical guidelines, and also taking into account the specifics of the sex and age composition of the population, the level and structure of the morbidity of the population of the Russian Federation, based on the data of medical statistics. (as amended by Federal Law of 25.12.2018 N 489-FL)

 

Article 81. Territorial Programme of State Guarantees of the Free Provision of Medical Care to Citizens

1. In accordance with the programme of state guarantees of the free provision of medical care to citizens, bodies of state power of constituent entities of the Russian Federation approve territorial programmes of state guarantees of the free provision of medical care to citizens, including territorial programmes of compulsory medical insurance established in accordance with the legislation of the Russian Federation on compulsory medical insurance.
2. Within the framework of the territorial programme of state guarantees of the free provision of medical care to citizens, bodies of state power of constituent entities of the Russian Federation establish:

1) the target values of the criteria of the accessibility of medical care in accordance with the criteria established by the programme of state guarantees of the free provision of medical care to citizens;

2) the list of diseases (states) and the list of types of medical care provided to citizens without charging them a fee at the expense of the budget allocations of the budget of the constituent entity of the Russian Federation and the funds of the budget of the territorial compulsory medical insurance fund;

3) the procedure and conditions of the provision of medical care, including the waiting times for medical care provided in a planned procedure;

4) the procedure for the realization of the right, established by the legislation of the Russian Federation, to the extraordinary provision of medical care to certain categories of citizens in medical organizations located in the territory of the constituent entity of the Russian Federation;

5) the list of medicinal products dispensed to the population in accordance with the List of Groups of the Population and Categories of Diseases in the Outpatient Treatment of Which Medicines and Medical Products Are Dispensed on Physicians’ Prescriptions Free of Charge, and also in accordance with the List of Groups of the Population in the Outpatient Treatment of Which Medicines Are Dispensed on Physicians’ Prescriptions with a Fifty Percent Discount, formed in a volume not less than that provided for by the list of vital and essential medicinal products approved by the Government of the Russian Federation in accordance with Federal Law of 12 April 2010 N 61-FL “On the Circulation of Medicines”; (as amended by Federal Law of 13.07.2020 N 206-FL)

6) the list of medical organizations participating in the implementation of the territorial programme of state guarantees of the free provision of medical care to citizens;

7) the volume of medical care provided within the framework of the territorial programme of state guarantees of the free provision of medical care to citizens in accordance with the legislation of the Russian Federation on compulsory medical insurance;

8) the volume of medical care per resident, the cost of the volume of medical care taking into account the conditions of its provision, the per capita financing standard;

9) the list of measures for the prevention of diseases and the formation of a healthy lifestyle carried out within the framework of the territorial programme of state guarantees of the free provision of medical care to citizens;

10) the procedure and amounts of reimbursement of expenses related to the provision of medical care in emergency form to citizens. (as amended by Federal Law of 25.11.2013 N 317-FL)

3. Territorial programmes of state guarantees of the free provision of medical care to citizens, subject to the fulfilment of the financial standards established by the programme of state guarantees of the free provision of medical care to citizens, may contain additional types and conditions of the provision of medical care, and also additional volumes of medical care, including those providing for the possibility of exceeding the averaged indicators established by the standards of medical care.
4. In the formation of the territorial programme of state guarantees of the free provision of medical care to citizens, the following are taken into account:

1) the procedures for the provision of medical care and the standards of medical care;

2) the specifics of the sex and age composition of the population;

3) the level and structure of the morbidity of the population of the constituent entity of the Russian Federation, based on the data of medical statistics;

4) the climatic and geographical specifics of the region and the transport accessibility of medical organizations;

5) the balance of the volume of medical care and its financial support, including the payment of insurance contributions for the compulsory medical insurance of the non-working population in the procedure established by the legislation of the Russian Federation on compulsory medical insurance.

5. The authorized federal executive body annually carries out monitoring of the formation, economic justification of the territorial programmes of state guarantees of the free provision of medical care to citizens and makes an assessment of the implementation of such programmes, and jointly with the Federal Compulsory Medical Insurance Fund – of the territorial programmes of compulsory medical insurance.
6. The authorized federal executive body, the Federal Compulsory Medical Insurance Fund and the highest executive bodies of constituent entities of the Russian Federation conclude agreements on the implementation of the territorial programmes of state guarantees of the free provision of medical care to citizens, including the territorial programmes of compulsory medical insurance, in the procedure established by the Government of the Russian Federation. The agreements specified in this Part are concluded in the form approved by the authorized federal executive body. (as amended by Federal Laws of 01.12.2014 N 418-FL, of 08.08.2024 N 232-FL)

 

Chapter 11. FINANCIAL SUPPORT IN THE SPHERE OF HEALTH PROTECTION

 

Article 82. Sources of Financial Support in the Sphere of Health Protection

The sources of financial support in the sphere of health protection are the funds of the federal budget, the budgets of constituent entities of the Russian Federation, local budgets, the funds of compulsory medical insurance, the funds of organizations and citizens, funds received from natural and legal persons, including voluntary donations, and other sources not prohibited by the legislation of the Russian Federation.

 

Article 83. Financial Support of the Provision of Medical Care and Sanatorium and Resort Treatment to Citizens

1. The financial support of the provision of primary health care to citizens is carried out at the expense of:

1) the funds of compulsory medical insurance;

2) the budget allocations of the federal budget, the budgets of constituent entities of the Russian Federation, allocated for the financial support of the implementation of the territorial programmes of state guarantees of the free provision of medical care to citizens (in the part of medical care not included in compulsory medical insurance programmes, and also of expenses not included in the structure of the tariffs for the payment of medical care provided for in compulsory medical insurance programmes);

3) other sources in accordance with this Federal Law.

2. The financial support of the provision of specialized, including high-tech, medical care to citizens is carried out at the expense of:

1) the funds of compulsory medical insurance;

2) the budget allocations of the budgets of constituent entities of the Russian Federation allocated within the framework of the territorial programmes of state guarantees of the free provision of medical care to citizens (in the part of medical care not included in the territorial programmes of compulsory medical insurance, and also of expenses not included in the structure of the tariffs for the payment of medical care provided for in the territorial programmes of compulsory medical insurance);

3) the budget allocations of the federal budget allocated to medical organizations subordinate to federal executive bodies (in the part of medical care not included in the basic programme of compulsory medical insurance, and also of expenses not included in the structure of the tariffs for the payment of medical care provided for in the basic programme of compulsory medical insurance); (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL, of 03.07.2016 N 286-FL)

3.1) the budget allocations of the budget of the Federal Compulsory Medical Insurance Fund for the financial support of high-tech medical care not included in the basic programme of compulsory medical insurance, provided to citizens of the Russian Federation by federal state institutions the functions and powers of the founder of which are exercised by federal executive bodies; (as amended by Federal Law of 03.07.2016 N 286-FL)

3.2) the budget allocations of the federal budget for the co-financing of the expenses of constituent entities of the Russian Federation arising in the provision to citizens of the Russian Federation of high-tech medical care not included in the basic programme of compulsory medical insurance. The procedure for the co-financing of the expenses of constituent entities of the Russian Federation specified in this Clause is established by the Government of the Russian Federation; (as amended by Federal Laws of 03.07.2016 N 286-FL, of 02.12.2019 N 399-FL)

4) other sources in accordance with this Federal Law.

3. The financial support of the provision of emergency, including emergency specialized, medical care to citizens is carried out at the expense of:

1) the funds of compulsory medical insurance;

2) the budget allocations of the budgets of constituent entities of the Russian Federation allocated for the financial support of the implementation of the territorial programmes of state guarantees of the free provision of medical care to citizens (in the part of medical care not included in the territorial programmes of compulsory medical insurance, and also of expenses not included in the structure of the tariffs for the payment of medical care provided for in the territorial programmes of compulsory medical insurance);

3) the budget allocations of the federal budget allocated to medical organizations subordinate to federal executive bodies and included in the list approved by the authorized federal executive body (in the part of medical care not included in the basic programme of compulsory medical insurance, and also of expenses not included in the structure of the tariffs for the payment of medical care provided for in the basic programme of compulsory medical insurance). (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL)

4. The financial support of the provision of palliative medical care to citizens is carried out at the expense of:

1) the budget allocations of the budgets of constituent entities of the Russian Federation allocated within the framework of the territorial programmes of state guarantees of the free provision of medical care to citizens;

2) other sources in accordance with this Federal Law.

5. The financial support of the sanatorium and resort treatment of citizens, except for medical rehabilitation, is carried out at the expense of:

1) the budget allocations of the relevant budgets allocated for certain categories of citizens established by the legislation of the Russian Federation, and the budget allocations of the federal budget allocated to federal executive bodies for the provision of state services for sanatorium and resort treatment;

2) other sources in accordance with this Federal Law.

5.1. The financial support of the provision of medical care within the framework of clinical approbation is carried out at the expense of the budget allocations of the federal budget provided for the said purposes. (as amended by Federal Law of 08.03.2015 N 55-FL)

6. The financial support of the provision of medical care to the population of certain territories and to workers of certain organizations specified in Part 1 of Article 42 of this Federal Law is carried out at the expense of: (as amended by Federal Law of 22.10.2014 N 314-FL)

1) the funds of compulsory medical insurance allocated within the framework of the territorial programmes of compulsory medical insurance;

2) the budget allocations of the federal budget (in the part of medical care not included in the basic programme of compulsory medical insurance, and also of expenses not included in the structure of the tariffs for the payment of medical care provided for in the basic programme of compulsory medical insurance).

6.1. The financial support of the provision of medical care to the persons specified in Part 3 of Article 42 of this Federal Law is carried out at the expense of: (as amended by Federal Law of 22.10.2014 N 314-FL)

1) the budget allocations of the federal budget; (as amended by Federal Law of 22.10.2014 N 314-FL)

2) the funds of compulsory medical insurance. (as amended by Federal Law of 22.10.2014 N 314-FL)

6.2. The financial support of the medical and biological support of the persons specified in Part 1 of Article 42.1 of this Federal Law is carried out: (as amended by Federal Law of 05.12.2017 N 373-FL)

1) in respect of athletes of the national sports teams of the Russian Federation – at the expense of the budget allocations provided for in the federal budget to the federal executive body exercising powers for the organization of the medical and biological support of athletes of the national sports teams of the Russian Federation; (as amended by Federal Law of 05.12.2017 N 373-FL)

2) in respect of athletes of the sports teams of constituent entities of the Russian Federation – at the expense of the budget allocations of the budgets of constituent entities of the Russian Federation. (as amended by Federal Law of 05.12.2017 N 373-FL)

7. The financial support of the provision of medical care to military servicemen and persons equated to them is carried out in accordance with the legislation of the Russian Federation.
8. The financial support of the provision of medical care to persons detained, taken into custody, serving a punishment in the form of restriction of liberty, arrest, deprivation of liberty or administrative arrest is carried out in accordance with the legislation of the Russian Federation.

Clause 10 of Part 1 of Article 16 and Part 9 of Article 83 have been recognized as not conforming to the Constitution of the Russian Federation, its Articles 7, 18, 19 (Part 2), 21 (Part 1) and 41 (Part 1), to the extent that they do not provide for a reserve mechanism for the provision with medicines of persons suffering from diseases included in the list of life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of a citizen or to disability, in the case when the corresponding duty imposed on the constituent entity of the Russian Federation cannot be properly performed (Resolution of the Constitutional Court of the RF of 26.09.2024 N 41-П).

9. The provision of citizens with medicinal products registered in the established procedure in the territory of the Russian Federation for the treatment of diseases included in the list of life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens or to their disability (except for the diseases specified in Clause 21 of Part 2 of Article 14 of this Federal Law) is carried out at the expense of the funds of the budgets of constituent entities of the Russian Federation. In the event of the impossibility of the performance by a constituent entity of the Russian Federation of the said powers, upon the confirmation of this fact in the procedure and on the basis of the criteria which are established by the Government of the Russian Federation, as an additional mechanism for the provision of citizens with medicinal products registered in the established procedure in the territory of the Russian Federation for the treatment of diseases included in the list of life-threatening and chronic progressive rare (orphan) diseases leading to a reduction in the life expectancy of citizens or to their disability, inter-budgetary transfers from the federal budget are provided to the budget of the constituent entity of the Russian Federation for the co-financing of the expenditure obligations of the constituent entity of the Russian Federation for the provision of citizens with the said medicinal products. The amount of such inter-budgetary transfers and the procedure for their provision are established by the Government of the Russian Federation. (as amended by Federal Law of 26.04.2016 N 112-FL, of 23.07.2025 N 252-FL)

9.1. The financial support of medical activity related to the donation of human organs, bone marrow and haematopoietic stem cells for the purposes of transplantation (grafting) is carried out at the expense of: (as amended by Federal Laws of 13.07.2015 N 271-FL, of 01.05.2022 N 129-FL)

1) the budget allocations provided for in the federal budget to the authorized federal executive body; (as amended by Federal Law of 13.07.2015 N 271-FL)

2) the budget allocations of the budgets of constituent entities of the Russian Federation provided for allocation to medical organizations subordinate to executive bodies of constituent entities of the Russian Federation. (as amended by Federal Laws of 13.07.2015 N 271-FL, of 08.08.2024 N 232-FL)

Normative legal acts of the RF establishing mandatory requirements and aimed at the implementation of the provisions of Part 9.2 of Article 83 of this document (as worded by Federal Law of 05.12.2022 N 469-FL) enter into force within the terms established by the said normative legal acts (Clause 2 of Article 2 of Federal Law of 05.12.2022 N 469-FL).

9.2. The provision with medicinal products of persons suffering from haemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, haemolytic-uraemic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis of types I, II and VI, aplastic anaemia, unspecified, hereditary deficiency of factors II (fibrinogen), VII (labile), X (Stuart-Prower), of persons after transplantation of organs and (or) tissues is carried out: (as amended by Federal Law of 05.12.2022 N 469-FL)

1) in respect of adults aged 18 years and older – at the expense of the budget allocations provided for in the federal budget to the authorized federal executive body; (as amended by Federal Law of 05.12.2022 N 469-FL)

2) in respect of children aged from 0 to 18 years – at the expense of the budget allocations provided for in the federal budget to the authorized federal executive body for the needs of the Fund for the Support of Children with Severe Life-Threatening and Chronic Diseases, Including Rare (Orphan) Diseases, “Circle of Kindness”, in accordance with the procedure for the acquisition of medicinal products and medical devices for a specific child with a severe life-threatening or chronic disease, including a rare (orphan) disease, or for groups of such children, established by the Government of the Russian Federation. (as amended by Federal Law of 05.12.2022 N 469-FL)

9.3. The provision to persons infected with the human immunodeficiency virus, including in combination with hepatitis B and C viruses, of antiviral medicinal products for medical use included in the list of vital and essential medicinal products is carried out at the expense of the budget allocations provided for in the federal budget for the said purposes. (as amended by Federal Law of 03.07.2016 N 286-FL)

9.4. The provision to persons suffering from tuberculosis with multiple drug resistance of the pathogen of antibacterial and anti-tuberculosis medicinal products for medical use included in the list of vital and essential medicinal products is carried out at the expense of the budget allocations provided for in the federal budget for the said purposes. (as amended by Federal Law of 03.07.2016 N 286-FL)

10. Expenses related to the provision of free medical care in emergency form to citizens by a medical organization, including a medical organization of the private health care system, are subject to reimbursement in the procedure and in the amounts established by the programme of state guarantees of the free provision of medical care to citizens.
11. The sources of financial support of the provision of medical care in cases not directly regulated by this Federal Law or other federal laws are determined taking into account the provisions of the programme of state guarantees of the free provision of medical care to citizens.

 

Article 84. Payment for Medical Services

1. Citizens have the right to receive paid medical services provided at their wish in the provision of medical care, and paid non-medical services (household, service, transport and other services) provided additionally in the provision of medical care.
2. Paid medical services are provided to patients at the expense of the personal funds of citizens, the funds of employers and other funds on the basis of contracts, including voluntary medical insurance contracts.
3. In the provision of paid medical services, the procedures for the provision of medical care must be observed.
4. Paid medical services may be provided in the full scope of the standard of medical care or, at the request of the patient, in the form of the carrying out of individual consultations or medical interventions, including in a scope exceeding the scope of the standard of medical care being performed.
5. Medical organizations participating in the implementation of the programme of state guarantees of the free provision of medical care to citizens and the territorial programme of state guarantees of the free provision of medical care to citizens have the right to provide paid medical services to patients:

1) on conditions other than those provided for by the programme of state guarantees of the free provision of medical care to citizens, the territorial programmes of state guarantees of the free provision of medical care to citizens and (or) targeted programmes;

2) in the anonymous provision of medical services, except for the cases provided for by the legislation of the Russian Federation;

3) to citizens of foreign states, stateless persons, except for persons insured under compulsory medical insurance, and to citizens of the Russian Federation not permanently residing in its territory and not being insured under compulsory medical insurance, unless otherwise provided for by international treaties of the Russian Federation;

4) upon independent application for receiving medical services, except for the cases and procedure provided for by Article 21 of this Federal Law.

6. The refusal of a patient of the paid medical services offered may not be a reason for reducing the types and scope of medical care provided to such patient without charging a fee within the framework of the programme of state guarantees of the free provision of medical care to citizens and the territorial programme of state guarantees of the free provision of medical care to citizens.
7. The procedure and conditions for the provision of paid medical services to patients by medical organizations are established by the Government of the Russian Federation.
8. The provisions of Law of the Russian Federation of 7 February 1992 N 2300-1 “On the Protection of Consumer Rights” apply to relations related to the provision of paid medical services.

 

Chapter 12. ORGANIZATION OF CONTROL IN THE SPHERE OF HEALTH PROTECTION

 

Article 85. Control (Supervision) in the Sphere of Health Protection (as amended by Federal Law of 11.06.2021 N 170-FL)

Control (supervision) in the sphere of health protection is carried out by means of:

1) federal state control (supervision) of the quality and safety of medical activity;

2) state control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of health protection; (as amended by Federal Law of 08.08.2024 N 232-FL)

3) state control (supervision) over the implementation by local self-government bodies of powers in the sphere of health protection;

4) federal state control (supervision) over the circulation of medical devices;

5) federal state control (supervision) in the sphere of the circulation of medicines established by Federal Law of 12 April 2010 N 61-FL “On the Circulation of Medicines”;

6) state control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of the circulation of medicines; (as amended by Federal Law of 08.08.2024 N 232-FL)

7) federal state control (supervision) in the sphere of the circulation of biomedical cellular products established by Federal Law of 23 June 2016 N 180-FL “On Biomedical Cellular Products”;

8) federal state sanitary and epidemiological control (supervision) established by Federal Law of 30 March 1999 N 52-FL “On the Sanitary and Epidemiological Well-Being of the Population”;

9) departmental control of the quality and safety of medical activity in accordance with this Federal Law;

10) internal control of the quality and safety of medical activity in accordance with this Federal Law.

 

Article 86. Powers of the Bodies Exercising State Control (Supervision) in the Sphere of Health Protection (as amended by Federal Law of 11.06.2021 N 170-FL)

1. The authorized federal executive bodies, executive bodies of constituent entities of the Russian Federation exercising state control (supervision) in the sphere of health protection (hereinafter – state control (supervision) bodies): (as amended by Federal Laws of 11.06.2021 N 170-FL, of 08.08.2024 N 232-FL)

1) issue orders mandatory for execution in the event of the identification of violations of the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines;

2) bring to liability for violation of the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines medical organizations and pharmaceutical organizations and their officials, officials of federal executive bodies, executive bodies of constituent entities of the Russian Federation, local self-government bodies, state extra-budgetary funds in the cases and in the procedure which are established by the legislation of the Russian Federation; (as amended by Federal Law of 08.08.2024 N 232-FL)

3) draw up protocols on administrative offences in the sphere of health protection, the circulation of medicines, consider cases of the said administrative offences and take measures for the prevention of such violations;

4) send to the authorized bodies materials related to violations of mandatory requirements for the resolution of matters of the institution of criminal cases on the grounds of crimes;

5) apply to a court with claims, applications on violations of the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines;

6) participate in the consideration by a court of cases related to the application and (or) violation of the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines;

7) place on the official website in the “Internet” network decisions and orders adopted in the process of the exercise of state control (supervision) in the sphere of health protection and affecting the interests of an indefinite range of persons. (as amended by Federal Law of 11.06.2021 N 170-FL)

2. In the consideration of applications on violation of the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines and the conduct of an inspection, workers of a state control (supervision) body, upon presentation of their service identity cards and the decision of the head of the state control (supervision) body, his deputy, on the conduct of an inspection of compliance with the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines, have the right to: (as amended by Federal Law of 11.06.2021 N 170-FL)

1) organize the conduct of the necessary studies, tests, expert examinations, analyses and assessments, including scientific research on matters of the exercise of control (supervision) in the established sphere of activity; (as amended by Federal Law of 11.06.2021 N 170-FL)

2) request and receive the data necessary for taking decisions on matters assigned to the competence of the state control (supervision) body; (as amended by Federal Law of 11.06.2021 N 170-FL)

3) give legal entities and natural persons clarifications on matters assigned to the competence of the state control (supervision) body; (as amended by Federal Law of 11.06.2021 N 170-FL)

4) involve, in the established procedure, scientific and other organizations, scientists and specialists for the elaboration of matters in the sphere of health protection;

5) obtain unimpeded access to the territory of the bodies or organizations being inspected or to the buildings, structures, constructions, premises used by the said bodies or organizations in the carrying out of their activity, to the equipment, similar objects, vehicles and transported cargoes used by them;

6) take samples of the goods produced in the procedure established by the legislation of the Russian Federation;

7) make copies of the documents necessary for the exercise of state control (supervision) in the sphere of health protection in the procedure established by the legislation of the Russian Federation; (as amended by Federal Law of 11.06.2021 N 170-FL)

8) apply measures of a restrictive, warning and preventive nature provided for by the legislation of the Russian Federation, aimed at the prevention and (or) elimination of the consequences of violation of the legislation of the Russian Federation in the sphere of health protection, the legislation of the Russian Federation on the circulation of medicines. (as amended by Federal Law of 27.12.2018 N 511-FL)

3. Part has ceased to be in force. (as amended by Federal Law of 11.06.2021 N 170-FL)

 

Article 87. Federal State Control (Supervision) of the Quality and Safety of Medical Activity (as amended by Federal Law of 11.06.2021 N 170-FL)

1. Federal state control (supervision) of the quality and safety of medical activity is exercised by the federal executive body exercising the functions of control and supervision in the sphere of health protection.
2. The subject matter of federal state control (supervision) of the quality and safety of medical activity is:

1) compliance by medical organizations (including medical workers), pharmaceutical organizations (including pharmaceutical workers), state extra-budgetary funds, individual entrepreneurs carrying out medical activity and individual entrepreneurs carrying out pharmaceutical activity with mandatory requirements in the sphere of health protection, requirements for objects used in the carrying out of activity in the sphere of health protection, including:

а) the rights of citizens in the sphere of health protection;

б) the procedures for the provision of medical care, the regulations on the organization of the provision of medical care by types of medical care, the rules for the conduct of laboratory, instrumental, pathologic-anatomical and other types of diagnostic studies, the procedures for the conduct of medical expert examinations, dispanserization, dispensary observation, medical examinations and medical certifications;

в) subclause has ceased to be in force. (as amended by Federal Law of 11.06.2021 N 170-FL)

г) the procedure and conditions for the provision of paid medical services, except for mandatory requirements assigned to the subject matter of federal state supervision in the field of consumer rights protection;

д) the restrictions imposed on medical workers, heads of medical organizations, pharmaceutical workers and heads of pharmacy organizations in the carrying out of their professional activity in accordance with this Federal Law;

е) the requirements for the organization and conduct of internal control of the quality and safety of medical activity;

ж) the requirements for the provision of the social service provided for by Clause 1 of Part 1 of Article 6.2 of Federal Law of 17 July 1999 N 178-FL “On State Social Assistance”;

з) the requirements for ensuring the accessibility for disabled persons of infrastructure facilities and services provided in the sphere of health protection;

Subclause “и” of Clause 2 of Article 87 is in force from 01.01.2022 (Clause 3 of Article 138 of Federal Law of 11.06.2021 N 170-FL).

и) the conformity of the medical care provided by medical workers to the criteria for the assessment of the quality of medical care;

к) the requirements related to the prescription of biologically active additives; (as amended by Federal Law of 07.06.2025 N 150-FL)

2) compliance with licensing requirements for the carrying out of medical activity.

3. In the exercise of federal state control (supervision) of the quality and safety of medical activity, the following types of control (supervisory) measures are conducted:

1) documentary inspection;

2) on-site inspection;

3) test purchase conducted for the purposes of verifying compliance by a medical organization with the procedure and conditions for the provision of paid medical services;

4) inspection visit.

4. The organization and exercise of federal state control (supervision) of the quality and safety of medical activity are regulated by Federal Law of 31 July 2020 N 248-FL “On State Control (Supervision) and Municipal Control in the Russian Federation”.
5. The regulations on federal state control (supervision) of the quality and safety of medical activity are approved by the Government of the Russian Federation.

 

Article 88. State Control (Supervision) over the Implementation by Executive Bodies of Constituent Entities of the Russian Federation of Powers in the Sphere of Health Protection and State Control (Supervision) over the Implementation by Local Self-Government Bodies of Powers in the Sphere of Health Protection (as amended by Federal Laws of 11.06.2021 N 170-FL, of 08.08.2024 N 232-FL)

1. State control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of health protection and state control (supervision) over the implementation by local self-government bodies of powers in the sphere of health protection are exercised by the federal executive body exercising the functions of control and supervision in the sphere of health protection. (as amended by Federal Law of 08.08.2024 N 232-FL)
2. The subject matter of state control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of health protection is compliance with: (as amended by Federal Law of 08.08.2024 N 232-FL)

1) the rights of citizens in the sphere of health protection;

2) the procedure for the organization and conduct of departmental control of the quality and safety of medical activity of the bodies and organizations subordinate to them;

To normative legal acts of the Russian Federation establishing mandatory requirements and provided for by Article 88 (as worded by Federal Law of 04.08.2023 N 462-FL), the provisions of Parts 1 and 3 of Article 3 and of Article 11 of Federal Law of 31.07.2020 N 247-FL “On Mandatory Requirements in the Russian Federation” do not apply (Clause 2 of Article 2 of Federal Law of 04.08.2023 N 462-FL).

3) the procedure and terms for the submission of the information provided for by Clauses 2 and 3 of Part 3 of Article 91.1 of this Federal Law (including in the part of the completeness, reliability, relevance of the data entered) to the unified state information system in the sphere of health care by the information providers specified in Clause 4 of Part 6 of Article 91.1 of this Federal Law. (as amended by Federal Law of 04.08.2023 N 462-FL)

3. The subject matter of state control (supervision) over the implementation by local self-government bodies of powers in the sphere of health protection is compliance with:

1) the rights of citizens in the sphere of health protection;

2) the procedure for the organization and conduct of departmental control of the quality and safety of medical activity of the bodies and organizations subordinate to them in the event of the transfer by bodies of state power of constituent entities of the Russian Federation in the sphere of health protection of powers for exercise to local self-government bodies in accordance with Part 2 of Article 16 of this Federal Law and Federal Law of 21 December 2021 N 414-FL “On the General Principles of the Organization of Public Power in the Constituent Entities of the Russian Federation”. (as amended by Federal Law of 08.08.2024 N 232-FL)

4. In the exercise of state control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of health protection and state control (supervision) over the implementation by local self-government bodies of powers in the sphere of health protection, the following types of measures are conducted: (as amended by Federal Law of 08.08.2024 N 232-FL)

1) documentary inspections;

2) on-site inspections.

5. The organization and exercise of state control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of health protection are regulated by Federal Law of 21 December 2021 N 414-FL “On the General Principles of the Organization of Public Power in the Constituent Entities of the Russian Federation”. (as amended by Federal Law of 08.08.2024 N 232-FL)
6. The organization and exercise of state control (supervision) over the implementation by local self-government bodies of powers in the sphere of health protection are regulated by Federal Law of 6 October 2003 N 131-FL “On the General Principles of the Organization of Local Self-Government in the Russian Federation”.
7. The regulations on state control (supervision) over the implementation by executive bodies of constituent entities of the Russian Federation of powers in the sphere of health protection and state control (supervision) over the implementation by local self-government bodies of powers in the sphere of health protection are approved by the Government of the Russian Federation. (as amended by Federal Law of 08.08.2024 N 232-FL)

 

Article 89. Departmental Control of the Quality and Safety of Medical Activity

1. Federal executive bodies, executive bodies of constituent entities of the Russian Federation and state extra-budgetary funds exercise departmental control of the quality and safety of medical activity of the bodies and organizations subordinate to them, the subject matter of which is compliance with the mandatory requirements specified in subclauses “а” – “в”, “д”, “е” and “з” of Clause 1 of Part 2 of Article 87 of this Federal Law and in Clause 1 of Part 2 of Article 95 of this Federal Law (in the part of compliance by medical organizations with the requirements for the safe application and operation of medical devices and their recycling (destruction), by means of the exercise of the powers provided for by Clauses 1 and 2 of Part 3 of Article 87 of this Federal Law. (as amended by Federal Laws of 11.06.2021 N 170-FL, of 08.08.2024 N 232-FL)
2. The procedure for the organization and conduct of departmental control of the quality and safety of medical activity is established by the authorized federal executive body.

 

Article 90. Internal Control of the Quality and Safety of Medical Activity

Bodies, organizations of the state, municipal and private health care systems exercise internal control of the quality and safety of medical activity in accordance with the requirements for its organization and conduct approved by the authorized federal executive body. (as amended by Federal Law of 25.12.2018 N 489-FL)

 

Article 91. Information Support in the Sphere of Health Care (as amended by Federal Law of 29.07.2017 N 242-FL)

1. Information support in the sphere of health care is carried out by means of the creation, development and operation of federal state information systems in the sphere of health care, information systems in the sphere of health care of the Federal Compulsory Medical Insurance Fund, including the development and operation of the state information system of compulsory medical insurance, and of territorial compulsory medical insurance funds, state information systems in the sphere of health care of constituent entities of the Russian Federation, medical information systems of medical organizations, information systems of pharmaceutical organizations (hereinafter – information systems in the sphere of health care). (as amended by Federal Law of 22.12.2020 N 438-FL)
2. In information systems in the sphere of health care, the collection, storage, processing and provision of information on bodies, organizations of the state, municipal and private health care systems and on the carrying out of medical and other activity in the sphere of health protection are carried out. The processing of personal data in information systems in the sphere of health care is carried out in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data, and in observance of medical secrecy.
3. The operators of information systems in the sphere of health care are the authorized federal executive body, other federal executive bodies in the sphere of health protection and their territorial bodies, the executive bodies of a constituent entity of the Russian Federation authorized by the highest executive body of the constituent entity of the Russian Federation to create, develop and operate the state information system in the sphere of health care of the constituent entity of the Russian Federation (hereinafter – authorized executive bodies of a constituent entity of the Russian Federation), organizations appointed by the said bodies, the management bodies of the Federal Compulsory Medical Insurance Fund and territorial compulsory medical insurance funds in the part concerning personalized records in the system of compulsory medical insurance, medical organizations and pharmaceutical organizations. (as amended by Federal Law of 08.08.2024 N 232-FL)
4. The requirements for state information systems in the sphere of health care of constituent entities of the Russian Federation, medical information systems of medical organizations and information systems of pharmaceutical organizations are established by the authorized federal executive body.
5. Other information systems intended for the collection, storage, processing and provision of information concerning the activity of medical organizations and the services provided by them (hereinafter – other information systems) may interact with information systems in the sphere of health care and medical organizations in the procedure, on the conditions and in accordance with the requirements established by the Government of the Russian Federation.
6. Other information systems are connected to the unified state system in the sphere of health care by the authorized federal executive body and to the unified identification and authentication system by the federal executive body of state power exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of information technologies.

 

Article 91.1. Unified State Information System in the Sphere of Health Care (as amended by Federal Law of 29.07.2017 N 242-FL)

1. For the purposes of ensuring the access of citizens to services in the sphere of health care in electronic form, and also the interaction of information systems in the sphere of health care, the authorized federal executive body creates, develops and operates the unified state information system in the sphere of health care (hereinafter – the unified system).
2. The regulations on the unified system, including the procedure for access to the information contained in it, the procedure and terms for the submission of information to the unified system, the procedure for the exchange of information with the use of the unified system, are approved by the Government of the Russian Federation.
3. The unified system includes:

1) data contained in federal information systems in the sphere of health care, federal databases, federal registers and federal registries in the sphere of health care, the maintenance of which is carried out by the authorized federal executive body with the use of the unified system; (as amended by Federal Law of 02.07.2021 N 313-FL)

2) data on medical organizations and pharmaceutical organizations (except for medical organizations and pharmaceutical organizations subordinate to federal executive bodies in which federal laws provide for military service or service equated to it, medical and pharmaceutical organizations subordinate to federal executive bodies whose activity is directed by the President of the Russian Federation, unless the said federal executive bodies have taken a different decision); (as amended by Federal Law of 28.12.2024 N 554-FL)

2.1) data on therapeutic and health-improving localities of federal significance, resorts of federal significance, resort regions, therapeutic and health-improving localities of regional significance, resorts of regional significance, natural healing resources, sanatorium and resort organizations (except for sanatorium and resort organizations subordinate to federal executive bodies in which federal laws provide for military service or service equated to it, sanatorium and resort organizations subordinate to federal executive bodies whose activity is directed by the President of the Russian Federation, unless the said federal executive bodies have taken a different decision); (as amended by Federal Laws of 04.08.2023 N 469-FL, of 28.12.2024 N 554-FL)

3) the data specified in Articles 93 and 93.1 of this Federal Law on persons who participate in the carrying out of medical activity and pharmaceutical activity, and also on persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education, except for data on persons who participate in the carrying out of medical activity and pharmaceutical activity in medical and pharmaceutical organizations subordinate to federal executive bodies in which federal laws provide for military service or service equated to it, unless the said federal executive bodies have taken a different decision, on persons studying in educational organizations subordinate to federal executive bodies in which federal laws provide for military service or service equated to it, unless the said federal executive bodies have taken a different decision, and also on persons studying in educational organizations and who have concluded with federal executive bodies in which federal laws provide for military service or service equated to it a contract on targeted training, unless the said federal executive bodies have taken a different decision; (as amended by Federal Law of 14.07.2022 N 275-FL)

4) the data specified in Article 94 of this Federal Law and depersonalized in the procedure established by the authorized federal executive body in agreement with the federal executive body exercising the functions of control and supervision in the sphere of mass media, on persons to whom medical care is provided, and also on persons in respect of whom medical expert examinations, medical examinations and medical certifications are conducted;

5) data on medical documentation, from the composition of which it is impossible to determine the state of health of a citizen, and data on the medical organization in which the medical documentation was created and is stored;

5.1) medical documentation and (or) data on the state of health of a citizen provided with the consent of the citizen (his legal representative) or placed by the citizen (his legal representative), including by means of the unified portal of state and municipal services; (as amended by Federal Law of 02.07.2021 N 358-FL)

6) statistical observation data in the sphere of health care, consolidated analytical information on matters of the carrying out of medical activity and the provision of medical care, and also of the carrying out of pharmaceutical activity; (as amended by Federal Law of 14.07.2022 N 275-FL)

6.1) data on the state registration of birth and on the state registration of death contained in the Unified State Register of Records of Acts of Civil Status, and data on the introduction of corrections or changes into the records of acts of birth and of death contained in the said register, used for the purposes of statistical observation in the sphere of health care, and also for updating the data contained in the federal registers and federal registries specified in Part 4 of this Article; (as amended by Federal Law of 02.07.2021 N 358-FL)

7) data on the organization of the provision of high-tech medical care;

7.1) data on the organization of the provision of specialized, including high-tech, medical care provided by medical organizations in respect of which the functions and powers of founders are exercised by the Government of the Russian Federation or federal executive bodies, in accordance with the uniform requirements of the basic programme of compulsory medical insurance; (as amended by Federal Law of 22.12.2020 N 438-FL)

8) data necessary for the carrying out of monitoring and control in the sphere of procurement of medicinal products for ensuring state and municipal needs;

9) data on the organization of the provision of citizens with medicinal products for medical use, medical devices (medical products) and specialized therapeutic nutrition products in accordance with Article 6.2 of Federal Law of 17 July 1999 N 178-FL “On State Social Assistance”, Clauses 19 and 20 of Part 1 of Article 14, Article 44 and Clause 5 of Part 2 of Article 81 of this Federal Law;

10) classifiers, reference books and other normative reference information in the sphere of health care, the list, procedure for maintenance and use of which are determined by the authorized federal executive body.

4. The unified system ensures the maintenance of the federal registers provided for by Part 2.1 of Article 43, Parts 4 and 8 of Article 44, Part 1 of Article 44.1 of this Federal Law and Article 24.1 of Law of the Russian Federation of 15 May 1991 N 1244-1 “On the Social Protection of Citizens Exposed to Radiation as a Result of the Catastrophe at the Chernobyl NPP”, and of the federal registries provided for by Part 1 of Article 53.1 and Part 1 of Article 68.1 of this Federal Law, of the state register of the resort fund of the Russian Federation provided for by Article 15.1 of Federal Law of 23 February 1995 N 26-FL “On Natural Healing Resources, Therapeutic and Health-Improving Localities and Resorts”. (as amended by Federal Laws of 02.07.2021 N 358-FL, of 04.08.2023 N 469-FL)

Normative legal acts establishing mandatory requirements in accordance with Part 4.1 of Article 91.1 (as worded by Federal Law of 02.07.2021 N 358-FL) enter into force within the terms established by the said normative legal acts (Clause 4 of Article 4 of Federal Law of 02.07.2021 N 358-FL).

4.1. The unified system, in addition to the federal registers specified in Part 4 of this Article, ensures the maintenance of other federal registers of persons with certain diseases or registers of other categories of persons in the cases and in the procedure which are established by the Government of the Russian Federation. (as amended by Federal Law of 02.07.2021 N 358-FL)

5. The unified system ensures the possibility of providing citizens with services in the sphere of health care in electronic form by means of the unified portal of state and municipal services, the list of which is approved by the Government of the Russian Federation.
6. The providers of information to the unified system and the users of the information contained in the unified system are: (as amended by Federal Law of 02.07.2021 N 358-FL)

1) the authorized federal executive body;

2) federal executive bodies in the sphere of health protection and other federal executive bodies in accordance with the powers established by the legislation of the Russian Federation;

3) the Federal Compulsory Medical Insurance Fund and territorial compulsory medical insurance funds, the Pension and Social Insurance Fund of the Russian Federation; (as amended by Federal Law of 28.12.2022 N 569-FL)

4) authorized executive bodies of a constituent entity of the Russian Federation; (as amended by Federal Law of 08.08.2024 N 232-FL)

5) local self-government bodies exercising powers in the sphere of health protection;

6) medical organizations and pharmaceutical organizations;

6.1) organizations carrying out educational activity under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education; (as amended by Federal Law of 14.07.2022 N 275-FL)

7) organizations which are operators of the other information systems specified in Part 5 of Article 91 of this Federal Law;

8) citizens. (as amended by Federal Law of 02.07.2021 N 358-FL)

6.1. The maintenance of the information resources of the unified system containing the data specified in Article 93.1 of this Federal Law on persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education is carried out with the use of the information contained in the information systems in the education system provided for by Article 98 of Federal Law of 29 December 2012 N 273-FL “On Education in the Russian Federation” (hereinafter – information systems in the education system). (as amended by Federal Law of 14.07.2022 N 275-FL)

7. Part has ceased to be in force. (as amended by Federal Law of 02.07.2021 N 358-FL)
8. Access to the information contained in the unified system is provided to the providers of information to the unified system, and also to the bodies and organizations which are users of the unified system, in accordance with their competence established by federal laws and normative legal acts of the President of the Russian Federation and the Government of the Russian Federation adopted in accordance with them. (as amended by Federal Law of 14.07.2022 N 275-FL)
9. On the basis of the information included in the unified system, information not containing personal data or containing depersonalized personal data may be formed. The procedure for the formation of such information and the rules for its provision to third parties are established by the authorized federal executive body. The submission of information constituting a state secret for inclusion in the unified system is not permitted. (as amended by Federal Law of 14.07.2022 N 275-FL)
10. The unified system interacts with the information systems in the education system with the use of the infrastructure ensuring the information and technological interaction of existing and newly created information systems used for the purposes of the provision of state and municipal services and the performance of state and municipal functions in electronic form. If the data specified in Article 93.1 of this Federal Law on persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education are contained in the information systems in the education system, such data are included in the unified system from the information systems in the education system in the procedure provided for by the regulations on the unified system approved by the Government of the Russian Federation in accordance with Part 2 of this Article. (as amended by Federal Law of 14.07.2022 N 275-FL)

To normative legal acts of the Russian Federation establishing mandatory requirements and provided for by Article 91.1 (as worded by Federal Law of 04.08.2023 N 462-FL), the provisions of Parts 1 and 3 of Article 3 and of Article 11 of Federal Law of 31.07.2020 N 247-FL “On Mandatory Requirements in the Russian Federation” do not apply (Clause 2 of Article 2 of Federal Law of 04.08.2023 N 462-FL).

11. For violation of the procedure and terms for the submission of information to the unified system (including in the part of the completeness, reliability, relevance of the data entered), the information providers specified in Clause 4 of Part 6 of this Article bear liability in accordance with the legislation of the Russian Federation. (as amended by Federal Law of 04.08.2023 N 462-FL)

 

Article 92. Maintenance of Personalized Records in the Sphere of Health Care (as amended by Federal Law of 14.07.2022 N 275-FL)

1. In the sphere of health care of the Russian Federation, records are kept of the personal data of persons participating in the carrying out of medical activity and pharmaceutical activity, persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education, persons to whom medical care is provided, and also persons in respect of whom medical expert examinations, medical examinations and medical certifications are conducted (hereinafter – personalized records). (as amended by Federal Law of 14.07.2022 N 275-FL)
2. For the purposes of the maintenance of personalized records, the operators of information systems in the sphere of health care specified in Part 3 of Article 91 of this Federal Law receive information from bodies and organizations of the state, municipal and private health care systems and other organizations within the framework of information interaction in accordance with this Federal Law. (as amended by Federal Law of 29.07.2017 N 242-FL)
3. The procedure for the maintenance of personalized records is determined by the authorized federal executive body, and in the part of personalized records of persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education – by the authorized federal executive body in agreement with the federal executive body exercising the functions of control and supervision in the sphere of education and science, the federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of general education, and the federal executive body exercising the functions of developing and implementing state policy and normative legal regulation in the sphere of higher education. (as amended by Federal Law of 14.07.2022 N 275-FL)
4. In the maintenance of personalized records, the confidentiality of the personal data of persons who participate in the carrying out of medical activity and pharmaceutical activity, persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education, persons to whom medical care is provided, and also persons in respect of whom medical expert examinations, medical examinations and medical certifications are conducted, and the security of the personal data of the said persons must be ensured in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data. (as amended by Federal Law of 14.07.2022 N 275-FL)

 

Article 93. Data on Persons Who Participate in the Carrying Out of Medical Activity and Pharmaceutical Activity (as amended by Federal Laws of 29.07.2017 N 242-FL, of 14.07.2022 N 275-FL)

For the purposes of the maintenance of personalized records, the following personal data on persons who participate in the carrying out of medical activity and pharmaceutical activity are processed: (as amended by Federal Laws of 29.07.2017 N 242-FL, of 14.07.2022 N 275-FL)

1) surname, name, patronymic (the latter – if any);

2) sex;

3) date of birth;

4) place of birth;

5) citizenship;

6) data of the identity document;

7) place of residence;

8) place of registration;

9) date of registration;

10) insurance number of the individual personal account (if any), adopted in accordance with the legislation of the Russian Federation on individual (personalized) records in the system of compulsory pension insurance;

11) data on education, on training or on the period of training, including data on the organizations carrying out educational activity in the implementation of professional educational programmes of medical education and pharmaceutical education, on documents on education and (or) qualification, on a contract on targeted training, and also data on the specialist certificate or on undergoing the accreditation of a specialist, data on the results of passing an examination for obtaining admission to carrying out medical activity or pharmaceutical activity in the positions of specialists with secondary medical or secondary pharmaceutical education; (as amended by Federal Laws of 29.07.2017 N 242-FL, of 02.07.2021 N 312-FL, of 14.07.2022 N 275-FL)

12) the name of the organization carrying out medical activity or the organization carrying out pharmaceutical activity; (as amended by Federal Laws of 29.07.2017 N 242-FL, of 14.07.2022 N 275-FL)

13) the position held in the organization carrying out medical activity or in the organization carrying out pharmaceutical activity; (as amended by Federal Laws of 29.07.2017 N 242-FL, of 14.07.2022 N 275-FL)

14) data on membership in the professional non-commercial organizations specified in Article 76 of this Federal Law (if any). (as amended by Federal Laws of 29.07.2017 N 242-FL, of 14.07.2022 N 275-FL)

 

Article 93.1. Data on Persons Studying under Educational Programmes of Secondary Vocational and Higher Medical Education, Educational Programmes of Secondary Vocational and Higher Pharmaceutical Education (as amended by Federal Law of 14.07.2022 N 275-FL)

For the purposes of the maintenance of personalized records of persons studying under educational programmes of secondary vocational and higher medical education, educational programmes of secondary vocational and higher pharmaceutical education, the following personal data are processed:

1) surname, name, patronymic (the latter – if any);

2) sex;

3) date of birth;

4) place of birth;

5) citizenship;

6) data of the identity document;

7) place of residence;

8) date of registration;

9) place of registration;

10) insurance number of the individual personal account (if any), adopted in accordance with the legislation of the Russian Federation on individual (personalized) records in the system of compulsory pension insurance;

11) data on education:

а) level of professional education;

б) code and name of the specialty of secondary vocational education, code and name of the specialty, field of training of higher education, code and name of the scientific specialty of higher education (under bachelor’s programmes, specialist programmes, master’s programmes, residency programmes, programmes for the training of scientific and scientific-pedagogical personnel in postgraduate studies (adjunct studies);

в) name of the organization carrying out educational activity in the implementation of professional educational programmes of medical education and pharmaceutical education;

г) form of study (full-time, part-time, extramural);

д) source of financing of receiving education (study at the expense of budget allocations or at the expense of the funds of natural and (or) legal persons);

12) period of mastering the educational programme (date of the beginning and date of the end of study), term of mastering the educational programme;

13) data on expulsion from study under the educational programme or on transfer to study under another educational programme, to another organization carrying out educational activity (if any);

14) data on targeted training (if any):

а) customer of targeted training (name of the federal state body, the body of state power of a constituent entity of the Russian Federation, the local self-government body or the legal entity, or the individual entrepreneur);

б) details of the contract on targeted training, name of the organization in which the citizen will be employed in accordance with the contract on targeted training.

 

Article 94. Data on Persons to Whom Medical Care Is Provided, and also on Persons in Respect of Whom Medical Expert Examinations, Medical Examinations and Medical Certifications Are Conducted (as amended by Federal Law of 29.07.2017 N 242-FL)

In the system of personalized records, the following personal data on persons to whom medical care is provided, and also on persons in respect of whom medical expert examinations, medical examinations and medical certifications are conducted, are processed: (as amended by Federal Law of 29.07.2017 N 242-FL)

1) surname, name, patronymic (the latter – if any);

2) sex;

3) date of birth;

4) place of birth;

5) citizenship;

6) data of the identity document;

7) place of residence;

8) place of registration;

9) date of registration;

10) insurance number of the individual personal account (if any), adopted in accordance with the legislation of the Russian Federation on individual (personalized) records in the system of compulsory pension insurance;

11) number of the compulsory medical insurance policy of the insured person (if any);

12) anamnesis;

13) diagnosis;

14) data on the organization carrying out medical activity; (as amended by Federal Law of 29.07.2017 N 242-FL)

15) type of medical care provided;

16) conditions of the provision of medical care;

17) terms of the provision of medical care;

18) scope of the medical care provided, including data on the medical services provided; (as amended by Federal Law of 29.07.2017 N 242-FL)

19) result of the application for medical care;

20) series and number of the certificate of incapacity for work issued (if any);

21) data on the medical expert examinations, medical examinations and medical certifications conducted and their results; (as amended by Federal Law of 29.07.2017 N 242-FL)

22) clinical guidelines applied; (as amended by Federal Law of 25.12.2018 N 489-FL)

23) data on the medical worker or medical workers who provided medical care, conducted medical expert examinations, medical examinations and medical certifications. (as amended by Federal Law of 29.07.2017 N 242-FL)

 

Article 95. Federal State Control (Supervision) over the Circulation of Medical Devices (as amended by Federal Law of 11.06.2021 N 170-FL)

1. Federal state control (supervision) over the circulation of medical devices is exercised by the federal executive body exercising the functions of control and supervision in the sphere of health protection.
2. The subject matter of federal state control (supervision) over the circulation of medical devices is:

1) compliance with mandatory requirements for the circulation of medical devices, including:

а) requirements for technical tests, toxicological studies, clinical trials, production, manufacture, import into the territory of the Russian Federation, confirmation of conformity, storage, transportation, sale, installation, adjustment, application, operation, including technical maintenance, repair, recycling and destruction;

б) requirements for the quality, safety and effectiveness of medical devices in circulation in the territory of the Russian Federation;

2) compliance with licensing requirements for activity in the production and technical maintenance (except for the case where technical maintenance is carried out for ensuring the own needs of a legal entity or an individual entrepreneur) of medical equipment;

3) compliance with the requirements for the provision by subjects of the circulation of medical devices of information on medical devices in accordance with this Federal Law.

3. In the exercise of federal state control (supervision) over the circulation of medical devices, the following types of control (supervisory) measures are conducted:

1) documentary inspection;

2) on-site inspection;

3) sample control;

4) test purchase;

5) inspection visit;

6) observation of compliance with mandatory requirements (safety monitoring).

Part 4 has been supplemented with Clause 1.1 (Clause 4 of Article 1 of Federal Law of 30.04.2021 N 128-FL).

4. The organization and exercise of federal state control (supervision) over the circulation of medical devices are regulated by Federal Law of 31 July 2020 N 248-FL “On State Control (Supervision) and Municipal Control in the Russian Federation”.
5. The regulations on federal state control (supervision) over the circulation of medical devices are approved by the Government of the Russian Federation.

 

Article 96. Monitoring of the Safety of Medical Devices

1. Medical devices in circulation in the territory of the Russian Federation are subject to safety monitoring for the purposes of identifying and preventing adverse events. The classification of adverse events is approved by the authorized federal executive body exercising the functions of control and supervision in the sphere of health protection. (as amended by Federal Law of 30.04.2021 N 128-FL)
2. The monitoring of the safety of medical devices is carried out by the federal executive body authorized by the Government of the Russian Federation at all stages of the circulation of such devices in the territory of the Russian Federation.
3. Subjects of the circulation of medical devices carrying out the types of activity provided for by Part 3 of Article 38 of this Federal Law are obliged to report, in the procedure established by the federal executive body authorized by the Government of the Russian Federation, all cases of the identification of adverse events at all stages of the circulation of the relevant medical device in the territory of the Russian Federation and the territories of other states. (as amended by Federal Law of 30.04.2021 N 128-FL)

3.1. The monitoring of the safety of medical devices is also carried out by means of the analysis of data which are submitted by the manufacturer (maker) of a medical device (its authorized representative) or the person carrying out the import of medical devices into the territory of the Russian Federation to the authorized federal executive body exercising the functions of control and supervision in the sphere of health protection, in the procedure established by it. (as amended by Federal Law of 30.04.2021 N 128-FL)

4. For failure to report or concealment of the cases and data provided for by Part 3 of this Article, persons to whom they became known by virtue of their professional activity bear liability in accordance with the legislation of the Russian Federation.
5. The procedure for the carrying out of the monitoring of the safety of medical devices, except for medical devices registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union, is established by the authorized federal executive body. (as amended by Federal Law of 30.04.2021 N 128-FL)
6. According to the results of the carrying out of the monitoring of the safety of medical devices, upon the receipt and confirmation of information on adverse events, the federal executive body authorized by the Government of the Russian Federation considers the matter of the suspension of the application or the withdrawal from circulation of such medical device and takes the relevant decision. (as amended by Federal Law of 30.04.2021 N 128-FL)
7. If the information specified in Part 6 of this Article is not confirmed, the federal executive body authorized by the Government of the Russian Federation resumes the application and circulation of such medical device.
8. The federal executive body authorized by the Government of the Russian Federation, according to the results of monitoring, places, in the procedure established by it, on its official website in the “Internet” network information on the decisions taken.

 

Article 97. Medical Statistics

1. Medical statistics is a branch of statistics including statistical data on medicine, hygiene, the health of the population, the use of health care resources, the activity of medical organizations.
2. Statistical observation in the sphere of health care is carried out by the authorized federal executive body.
3. The procedure for the carrying out of statistical observation in the sphere of health care, the forms of statistical accounting and reporting in the sphere of health care, the procedure for filling them in and the terms of their submission are established by the authorized federal executive body.
4. Official statistical information in the sphere of health care is publicly available and is placed by the authorized federal executive body in the mass media, including in the “Internet” network.

 

Chapter 13. LIABILITY IN THE SPHERE OF HEALTH PROTECTION

 

Article 98. Liability in the Sphere of Health Protection

1. Bodies of state power and local self-government bodies, officials of organizations bear responsibility for ensuring the realization of the guarantees and the observance of the rights and freedoms in the sphere of health protection established by the legislation of the Russian Federation.
2. Medical organizations, medical workers and pharmaceutical workers bear liability in accordance with the legislation of the Russian Federation for the violation of rights in the sphere of health protection, the causing of harm to life and (or) health in the provision of medical care to citizens.
3. Harm caused to the life and (or) health of citizens in the provision of medical care to them is compensated by medical organizations in the scope and procedure established by the legislation of the Russian Federation.
4. The compensation of harm caused to the life and (or) health of citizens does not release medical workers and pharmaceutical workers from being brought to liability in accordance with the legislation of the Russian Federation.

 

Chapter 14. FINAL PROVISIONS

 

Article 99. Recognition as Not in Effect in the Territory of the Russian Federation of Certain Legislative Acts of the Union of SSR and as Having Ceased to Be in Force of Certain Legislative Acts of the RSFSR and the Russian Federation (Their Individual Provisions)

1. To recognize as not in effect in the territory of the Russian Federation:

1) Law of the USSR of 19 December 1969 N 4589-7 “On the Approval of the Fundamentals of the Legislation of the Union of SSR and the Union Republics on Health Care” (Vedomosti of the Supreme Soviet of the USSR, 1969, N 52, Art. 466);

2) Decree of the Presidium of the Supreme Soviet of the USSR of 1 June 1970 N 5215-7 “On the Procedure for the Entry into Effect of the Fundamentals of the Legislation of the Union of SSR and the Union Republics on Health Care” (Vedomosti of the Supreme Soviet of the USSR, 1970, N 23, Art. 192);

3) Decree of the Presidium of the Supreme Soviet of the USSR of 26 March 1971 N 1364-8 “On the Approval of the Text of the Oath of a Physician of the Soviet Union and the Regulations on the Procedure for Taking the Oath” (Vedomosti of the Supreme Soviet of the USSR, 1971, N 13, Art. 145);

4) Decree of the Presidium of the Supreme Soviet of the USSR of 18 June 1979 N 286-10 “On Introducing Amendments and Additions to the Fundamentals of the Legislation of the Union of SSR and the Union Republics on Health Care” (Vedomosti of the Supreme Soviet of the USSR, 1979, N 25, Art. 438);

5) Decree of the Presidium of the Supreme Soviet of the USSR of 15 November 1983 N 10274-10 “On Supplementing the Text of the Oath of a Physician of the Soviet Union” (Vedomosti of the Supreme Soviet of the USSR, 1983, N 47, Art. 722);

6) Clause 4 of Section I of the Decree of the Presidium of the Supreme Soviet of the USSR of 8 June 1984 N 340-11 “On Introducing Amendments and Additions to Certain Legislative Acts of the Union of SSR” (Vedomosti of the Supreme Soviet of the USSR, 1984, N 24, Art. 422);

7) Article 1 of the Law of the USSR of 27 November 1985 N 3662-11 “On Introducing Amendments to Certain Legislative Acts of the USSR in Connection with the Main Directions of the Reform of the General Education and Vocational School and the Approval of the New Wording of the Fundamentals of the Legislation of the Union of SSR and the Union Republics on Public Education” (Vedomosti of the Supreme Soviet of the USSR, 1985, N 48, Art. 919);

8) Decree of the Presidium of the Supreme Soviet of the USSR of 25 August 1987 N 7612-11 “On Measures for the Prevention of Infection with the AIDS Virus” (Vedomosti of the Supreme Soviet of the USSR, 1987, N 34, Art. 560);

9) Decree of the Presidium of the Supreme Soviet of the USSR of 5 January 1988 N 8282-11 “On the Approval of the Regulations on the Conditions and Procedure for the Provision of Psychiatric Care” (Vedomosti of the Supreme Soviet of the USSR, 1988, N 2, Art. 19);

10) Law of the USSR of 26 May 1988 N 9004-11 “On the Approval of the Decrees of the Presidium of the Supreme Soviet of the USSR on Introducing Amendments and Additions to Legislative Acts of the USSR” in the part of the approval of the Decree of the Presidium of the Supreme Soviet of the USSR of 5 January 1988 “On the Approval of the Regulations on the Conditions and Procedure for the Provision of Psychiatric Care” (Vedomosti of the Supreme Soviet of the USSR, 1988, N 22, Art. 361);

11) Law of the USSR of 23 April 1990 N 1447-1 “On the Prevention of AIDS” (Vedomosti of the Congress of People’s Deputies of the USSR and the Supreme Soviet of the USSR, 1990, N 19, Art. 324);

12) Resolution of the Supreme Soviet of the USSR of 23 April 1990 N 1448-1 “On the Procedure for the Entry into Effect of the Law of the USSR “On the Prevention of AIDS” (Vedomosti of the Congress of People’s Deputies of the USSR and the Supreme Soviet of the USSR, 1990, N 19, Art. 325);

13) Law of the USSR of 23 April 1990 N 1449-1 “On Introducing an Addition to the Fundamentals of the Legislation of the Union of SSR and the Union Republics on Health Care” (Vedomosti of the Congress of People’s Deputies of the USSR and the Supreme Soviet of the USSR, 1990, N 19, Art. 326);

14) Clause 5 of Section I of the Law of the USSR of 22 May 1990 N 1501-1 “On Introducing Amendments and Additions to Certain Legislative Acts of the USSR on Matters Concerning Women, the Family and Childhood” (Vedomosti of the Congress of People’s Deputies of the USSR and the Supreme Soviet of the USSR, 1990, N 23, Art. 422).

2. To recognize as having ceased to be in force:

1) Resolution of the Supreme Soviet of the RSFSR of 29 July 1971 “On the Entry into Effect of the Law of the RSFSR “On Health Care” (Vedomosti of the Supreme Soviet of the RSFSR, 1971, N 31, Art. 657);

2) Decree of the Presidium of the Supreme Soviet of the RSFSR of 20 October 1971 “On the Procedure for the Entry into Effect of the Law of the Russian Soviet Federative Socialist Republic on Health Care” (Vedomosti of the Supreme Soviet of the RSFSR, 1971, N 42, Art. 880);

3) Clause 4 of the Decree of the Presidium of the Supreme Soviet of the RSFSR of 15 July 1974 “On Introducing Amendments and Additions to Certain Legislative Acts of the RSFSR” (Vedomosti of the Supreme Soviet of the RSFSR, 1974, N 29, Art. 782);

4) Decree of the Presidium of the Supreme Soviet of the RSFSR of 11 July 1979 “On Strengthening the Combat against the Spread of Venereal Diseases” (Vedomosti of the Supreme Soviet of the RSFSR, 1979, N 29, Art. 712);

5) Law of the RSFSR of 3 August 1979 “On the Approval of the Decree of the Presidium of the Supreme Soviet of the RSFSR “On Strengthening the Combat against the Spread of Venereal Diseases” (Vedomosti of the Supreme Soviet of the RSFSR, 1979, N 32, Art. 792);

6) Clause 3 of the Decree of the Presidium of the Supreme Soviet of the RSFSR of 18 January 1985 “On Introducing Amendments and Additions to Certain Legislative Acts of the RSFSR” (Vedomosti of the Supreme Soviet of the RSFSR, 1985, N 4, Art. 117);

7) Section IV of the Decree of the Presidium of the Supreme Soviet of the RSFSR of 1 October 1985 N 1524-11 “On Introducing Amendments and Additions to Certain Legislative Acts of the RSFSR” (Vedomosti of the Supreme Soviet of the RSFSR, 1985, N 40, Art. 1398);

8) Clause 4 of Section I of the Decree of the Presidium of the Supreme Soviet of the RSFSR of 29 January 1986 N 2525-11 “On the Amendment and Recognition as Having Ceased to Be in Force of Certain Legislative Acts of the RSFSR on Administrative Offences” (Vedomosti of the Supreme Soviet of the RSFSR, 1986, N 6, Art. 175);

9) Decree of the Presidium of the Supreme Soviet of the RSFSR of 6 August 1986 N 3785-11 “On Introducing Amendments and Additions to Certain Legislative Acts of the RSFSR and the Approval of the Regulations on the Medical and Educational Preventorium for Persons Suffering from Drug Addiction” (Vedomosti of the Supreme Soviet of the RSFSR, 1986, N 33, Art. 919);

10) the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens of 22 July 1993 N 5487-1 (Vedomosti of the Congress of People’s Deputies of the Russian Federation and the Supreme Soviet of the Russian Federation, 1993, N 33, Art. 1318);

11) Clause 3 of Article 1 of Federal Law of 2 March 1998 N 30-FL “On Introducing Amendments and Additions to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law “On Advertising” (Collection of Legislation of the Russian Federation, 1998, N 10, Art. 1143);

12) Federal Law of 20 December 1999 N 214-FL “On Introducing an Amendment to Article 60 of the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens” (Collection of Legislation of the Russian Federation, 1999, N 51, Art. 6289);

13) Federal Law of 2 December 2000 N 139-FL “On Introducing Amendments and an Addition to the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens” (Collection of Legislation of the Russian Federation, 2000, N 49, Art. 4740);

14) Article 11 of Federal Law of 10 January 2003 N 15-FL “On Introducing Amendments and Additions to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law “On the Licensing of Certain Types of Activity” (Collection of Legislation of the Russian Federation, 2003, N 2, Art. 167);

15) Clause 1 of Article 9 of Federal Law of 27 February 2003 N 29-FL “On the Specifics of the Management and Disposal of the Property of Railway Transport” (Collection of Legislation of the Russian Federation, 2003, N 9, Art. 805);

16) Article 5 of Federal Law of 30 June 2003 N 86-FL “On Introducing Amendments and Additions to Certain Legislative Acts of the Russian Federation, the Recognition as Having Ceased to Be in Force of Certain Legislative Acts of the Russian Federation, the Provision of Certain Guarantees to Officers of Internal Affairs Bodies, Bodies for Control over the Turnover of Narcotic Drugs and Psychotropic Substances and the Federal Tax Police Bodies Being Abolished in Connection with the Implementation of Measures for the Improvement of State Administration” (Collection of Legislation of the Russian Federation, 2003, N 27, Art. 2700);

17) Article 22 of Federal Law of 29 June 2004 N 58-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation and the Recognition as Having Ceased to Be in Force of Certain Legislative Acts of the Russian Federation in Connection with the Implementation of Measures for the Improvement of State Administration” (Collection of Legislation of the Russian Federation, 2004, N 27, Art. 2711);

18) Article 35 of Federal Law of 22 August 2004 N 122-FL “On Introducing Amendments to Legislative Acts of the Russian Federation and the Recognition as Having Ceased to Be in Force of Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Laws “On Introducing Amendments and Additions to the Federal Law “On the General Principles of the Organization of Legislative (Representative) and Executive Bodies of State Power of Constituent Entities of the Russian Federation” and “On the General Principles of the Organization of Local Self-Government in the Russian Federation” (Collection of Legislation of the Russian Federation, 2004, N 35, Art. 3607);

19) Federal Law of 1 December 2004 N 151-FL “On Introducing Amendments to the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens” (Collection of Legislation of the Russian Federation, 2004, N 49, Art. 4850);

20) Federal Law of 21 December 2005 N 170-FL “On Introducing an Amendment to Article 61 of the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens” (Collection of Legislation of the Russian Federation, 2005, N 52, Art. 5583);

21) Article 5 of Federal Law of 31 December 2005 N 199-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Improvement of the Delimitation of Powers” (Collection of Legislation of the Russian Federation, 2006, N 1, Art. 10);

22) Federal Law of 2 February 2006 N 23-FL “On Introducing an Amendment to Article 52 of the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens” (Collection of Legislation of the Russian Federation, 2006, N 6, Art. 640);

23) Article 6 of Federal Law of 29 December 2006 N 258-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Improvement of the Delimitation of Powers” (Collection of Legislation of the Russian Federation, 2007, N 1, Art. 21);

24) Article 6 and Clause 2 of Article 33 of Federal Law of 18 October 2007 N 230-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Improvement of the Delimitation of Powers” (Collection of Legislation of the Russian Federation, 2007, N 43, Art. 5084);

25) Article 15 of Federal Law of 23 July 2008 N 160-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Improvement of the Exercise of the Powers of the Government of the Russian Federation” (Collection of Legislation of the Russian Federation, 2008, N 30, Art. 3616);

26) Article 1 of Federal Law of 8 November 2008 N 203-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation on Matters of the Medical and Psychological Rehabilitation of Military Servicemen” (Collection of Legislation of the Russian Federation, 2008, N 45, Art. 5149);

27) Article 6 of Federal Law of 25 December 2008 N 281-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation” (Collection of Legislation of the Russian Federation, 2008, N 52, Art. 6236);

28) Article 7 of Federal Law of 24 July 2009 N 213-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation and the Recognition as Having Ceased to Be in Force of Certain Legislative Acts (Provisions of Legislative Acts) of the Russian Federation in Connection with the Adoption of the Federal Law “On Insurance Contributions to the Pension Fund of the Russian Federation, the Social Insurance Fund of the Russian Federation, the Federal Compulsory Medical Insurance Fund and Territorial Compulsory Medical Insurance Funds” (Collection of Legislation of the Russian Federation, 2009, N 30, Art. 3739);

29) Article 1 of Federal Law of 25 November 2009 N 267-FL “On Introducing Amendments to the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens and Certain Legislative Acts of the Russian Federation” (Collection of Legislation of the Russian Federation, 2009, N 48, Art. 5717);

30) Article 4 of Federal Law of 27 December 2009 N 365-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Improvement of the Activity of Bodies of State Power of Constituent Entities of the Russian Federation and Local Self-Government Bodies” (Collection of Legislation of the Russian Federation, 2009, N 52, Art. 6441);

31) Article 1 of Federal Law of 27 July 2010 N 192-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in the Part of Increasing the Accessibility of the Provision of Medicines to Residents of Rural Settlements” (Collection of Legislation of the Russian Federation, 2010, N 31, Art. 4161);

32) Article 2 of Federal Law of 28 September 2010 N 243-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law “On the Innovation Centre “Skolkovo” (Collection of Legislation of the Russian Federation, 2010, N 40, Art. 4969);

33) Article 6 of Federal Law of 18 July 2011 N 242-FL “On Introducing Amendments to Certain Legislative Acts of the Russian Federation on Matters of the Exercise of State Control (Supervision) and Municipal Control” (Collection of Legislation of the Russian Federation, 2011, N 30, Art. 4590).

 

Article 100. Final Provisions

1. Until 1 January 2026: (as amended by Federal Law of 29.12.2015 N 389-FL)

1) the right to carry out medical activity in the Russian Federation belongs to persons who have received medical or other education in the Russian Federation and have a specialist certificate; (as amended by Federal Law of 02.07.2021 N 312-FL)

2) the right to engage in pharmaceutical activity in the Russian Federation belongs to persons who have received pharmaceutical education in the Russian Federation and have a specialist certificate, and also to persons having the right to engage in medical activity and who have received additional professional education in the part of retail trade in medicinal products, provided that they work in separate subdivisions of medical organizations having a licence to carry out pharmaceutical activity located in rural settlements in which there are no pharmacy organizations; (as amended by Federal Laws of 02.07.2021 N 312-FL, of 08.08.2024 N 323-FL)

3) persons who have received medical or pharmaceutical education who have not worked in their specialty for more than five years may be admitted to medical activity or pharmaceutical activity in accordance with the specialty received after undergoing training under additional professional programmes (professional retraining) and if they have a specialist certificate; (as amended by Federal Law of 02.07.2013 N 185-FL)

4) persons who have received medical or pharmaceutical education in foreign states are admitted to medical activity or pharmaceutical activity after the recognition in the Russian Federation of the education and (or) qualification received in a foreign state in the procedure established by the legislation on education, passing an examination in the specialty in the procedure established by the authorized federal executive body, and receiving a specialist certificate, unless otherwise provided for by international treaties of the Russian Federation. (as amended by Federal Law of 02.07.2013 N 185-FL)

1.1. The transition to the procedure of the accreditation of specialists is carried out in stages from 1 January 2016 to 31 December 2025 inclusive. The terms and stages of the said transition, and also the categories of persons having medical, pharmaceutical or other education and subject to the accreditation of specialists, are determined by the authorized federal executive body. (as amended by Federal Law of 29.12.2015 N 389-FL)

2. Specialist certificates issued to medical and pharmaceutical workers before 1 January 2021 are valid until the expiry of the term specified in them. The form, conditions and procedure for the issuance of a specialist certificate are established by the authorized federal executive body. (as amended by Federal Law of 29.12.2015 N 389-FL)
3. Part has ceased to be in force. (as amended by Federal Law of 02.07.2013 N 185-FL)

The provisions of Part 4 of Article 100 apply until the expiry of the standard terms of mastering the educational programmes by persons admitted to such training. From 01.09.2017, the provisions of Part 4 of Article 100 do not apply (Part 9 of Article 101).

4. Training in internship ensures the acquisition by a specialist of the necessary level of knowledge, abilities and skills, and also of a qualification allowing him to hold the positions of medical workers and pharmaceutical workers. The duration of training in internship may not exceed one year. (as amended by Federal Law of 02.07.2013 N 185-FL)

The provisions of Part 4.1 of Article 100 apply until the expiry of the standard terms of mastering the educational programmes by persons admitted to such training. From 01.09.2017, the provisions of Part 4.1 of Article 100 do not apply (Part 9 of Article 101).

4.1. Persons having higher medical education and (or) higher pharmaceutical education and studying in internship are interns, and the rights, duties, measures of social support and stimulation of residents established by Federal Law of 29 December 2012 N 273-FL “On Education in the Russian Federation” extend to them, and the rules established for the carrying out of educational activity under residency programmes apply to the carrying out of educational activity under internship programmes. (as amended by Federal Law of 02.07.2013 N 185-FL)

5.-6. Parts have ceased to be in force. (as amended by Federal Law of 02.07.2013 N 185-FL)

7. Until 1 January 2015, the financial support of the provision of specialized medical care (except for high-tech medical care) in medical organizations subordinate to federal executive bodies is carried out at the expense of the budget allocations of the federal budget and the funds of compulsory medical insurance within the framework of the territorial programmes of compulsory medical insurance. (as amended by Federal Law of 01.12.2014 N 418-FL)
8. Until 1 January 2015, the financial support of the powers of the Russian Federation and constituent entities of the Russian Federation for the provision of emergency medical care is carried out, respectively, at the expense of the budget allocations of the federal budget and the budget allocations of the budgets of constituent entities of the Russian Federation and the funds of compulsory medical insurance within the framework of the territorial programmes of compulsory medical insurance.
9. In 2015, the financial support of high-tech medical care is carried out at the expense of the budget allocations of the federal budget and the budgets of constituent entities of the Russian Federation, including funds transferred to the budgets of territorial compulsory medical insurance funds, and also the funds of compulsory medical insurance. (as amended by Federal Laws of 25.11.2013 N 317-FL, of 01.12.2014 N 418-FL)
10. The licensing of medical activity providing for the provision of services in high-tech medical care is a power of the Russian Federation. (as amended by Federal Law of 25.11.2013 N 317-FL)
11. Until 1 January 2013, medical organizations may apply the procedures for the provision of medical care and the standards of medical care approved by the authorized federal executive body in accordance with this Federal Law, including within the framework of the implementation of regional programmes of modernization of health care of constituent entities of the Russian Federation.
12. Buildings, structures, equipment, vehicles and other property used by local self-government bodies for the purposes of health protection and in municipal ownership before the day of the entry into force of this Federal Law are transferred to the ownership of the relevant constituent entities of the Russian Federation within the term until 1 January 2013 in the procedure established by the legislation of the Russian Federation.
13. Buildings, structures, equipment, vehicles and other property used by local self-government bodies for the purposes of health protection and in municipal ownership before the transfer of the exercise of the powers to local self-government bodies provided for by Part 2 of Article 16 of this Federal Law may be retained in the ownership of municipal formations provided that they are used for their intended purpose.
14. Medical workers and pharmaceutical workers, for the period of work in medical organizations of the state health care system of constituent entities of the Russian Federation, retain the right to use the service residential premises provided to them during the period of work in medical organizations of the municipal health care system.
15. Licences for the carrying out of certain types of activity granted before 1 January 2012 to medical organizations of the municipal health care system are not subject to re-execution in connection with the transfer of the said medical organizations into the state health care system and are valid until the expiry of the term specified in them. Licences for the carrying out of medical activity granted before 1 January 2012 to medical organizations are not subject to re-execution in connection with the change of the classification of types of medical care and the list of services provided established by the regulations on the licensing of medical activity, and are valid until the expiry of the term specified in them. Licences for the carrying out of medical activity granted to medical organizations before the date of the entry into force of the relevant provisions of Federal Law of 25 July 2002 N 115-FL “On the Legal Status of Foreign Citizens in the Russian Federation” changing the cases and (or) procedure for the submission of documents confirming the absence in a foreign citizen or a stateless person of drug addiction and infectious diseases posing a danger to others provided for by the list approved by the federal executive body authorized by the Government of the Russian Federation, and also of a certificate of the absence in a foreign citizen or a stateless person of the disease caused by the human immunodeficiency virus (HIV infection), are not subject to re-execution and are valid until the expiry of the term specified in them. (as amended by Federal Laws of 28.12.2013 N 386-FL, of 27.12.2019 N 478-FL)
16. To persons having the right to choose a physician and to choose a medical organization in accordance with the provisions of Part 2 of Article 21 of this Federal Law, until the moment of the realization of the said right, primary medical health care is provided in the medical organizations in which the said persons received medical services, by general practitioners (therapists), district general practitioners (therapists), paediatricians, district paediatricians, general practice physicians (family physicians) and feldshers who provided medical services to the said persons.
17. From 1 January to 31 December 2012, the Russian Federation, in the procedure established by Article 15 of this Federal Law, transfers to bodies of state power of constituent entities of the Russian Federation the exercise of the power of licensing the medical activity (except for activity providing for the provision of services in the provision of high-tech medical care):

1) of medical organizations subordinate to a constituent entity of the Russian Federation and in municipal ownership as of 1 January 2011;

2) of medical organizations of the municipal and private health care systems.

18. In 2012, the implementation of the programme of state guarantees of the free provision of medical care to citizens and of the territorial programmes of state guarantees of the free provision of medical care to citizens is carried out in accordance with the normative legal acts adopted in pursuance of Article 20.1 of the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens of 22 July 1993 N 5487-1.

 

Article 101. Procedure for the Entry into Force of this Federal Law

1. This Federal Law enters into force from the day of its official publication, except for the provisions for which this Article establishes other terms of their entry into force.
2. Chapter 1, Articles 4 – 9, Article 10 (except for Clause 4), Articles 11 – 13, Part 1, Clauses 1 – 4, 6 – 17 of Part 2 of Article 14, subclauses “б” and “в” of Clause 1 of Part 1, Part 2, Clause 1 of Part 3, Parts 4 – 11 of Article 15, Articles 16 – 19, Parts 1 – 7 and 9 – 11 of Article 20, Articles 21 – 36, Articles 38 – 57, Parts 1, 2 and 4 of Article 58, Articles 59 – 63, Parts 1, 3 and 4 of Article 64, Articles 65 – 68, Part 5 of Article 69, Articles 70 – 83, Parts 1, 2, 4 – 8 of Article 84, Articles 85 – 100 of this Federal Law enter into force from 1 January 2012.
3. Clause 4 of Article 10, subclause “а” of Clause 1 of Part 1, Part 12 of Article 15, Part 1 of Article 37 and Part 3 of Article 84 of this Federal Law enter into force from 1 January 2013.
4. Part has ceased to be in force. (as amended by Federal Law of 26.04.2016 N 112-FL)
5. Part 3 of Article 58 and Part 2 of Article 64 of this Federal Law enter into force from 1 January 2015.
6. Parts 1 – 4, 6 and 7 of Article 69 of this Federal Law enter into force from 1 January 2016.
7. The provisions of Part 4 of Article 38 of this Federal Law in the part of the approval of the procedure for the state registration of medical devices apply from 1 January 2013. (as amended by Federal Law of 25.06.2012 N 89-FL)
8. The provisions of Part 4 of Article 34 of this Federal Law apply until 1 January 2015. (as amended by Federal Law of 25.11.2013 N 317-FL)

8.1. The provisions of Parts 5 – 7 of Article 34 of this Federal Law apply until 1 January 2017. (as amended by Federal Laws of 01.12.2014 N 418-FL, of 14.12.2015 N 374-FL)

9. The provisions of Parts 4 and 4.1 of Article 100 of this Federal Law apply until the expiry of the standard terms of mastering the educational programmes by persons admitted to such training. From 1 September 2017, the provisions of Parts 4 and 4.1 of Article 100 of this Federal Law do not apply. (as amended by Federal Law of 02.07.2013 N 185-FL)

 

President
of the Russian Federation
MEDVEDEV

Moscow, Kremlin
21 November 2011
N 323-FL