{"id":2439,"date":"2026-09-01T12:47:09","date_gmt":"2026-09-01T09:47:09","guid":{"rendered":"https:\/\/grandlocus.com\/?post_type=resources&p=2439"},"modified":"2026-09-01T12:56:11","modified_gmt":"2026-09-01T09:56:11","slug":"government-of-the-russian-federation-resolution-of-may-31-2023-no-894","status":"publish","type":"resources","link":"https:\/\/grandlocus.com\/en\/resources\/government-of-the-russian-federation-resolution-of-may-31-2023-no-894\/","title":{"rendered":"Government of the Russian Federation resolution of May 31, 2023 No. 894"},"content":{"rendered":"

 <\/p>\n

GOVERNMENT OF THE RUSSIAN FEDERATION<\/strong><\/h4>\n

RESOLUTION<\/strong>
\nof May 31, 2023 No. 894<\/strong><\/h4>\n

ON APPROVAL OF THE RULES FOR LABELING CERTAIN TYPES OF MEDICAL DEVICES WITH IDENTIFICATION MEANS AND THE SPECIFICS OF IMPLEMENTATION OF THE STATE INFORMATION SYSTEM FOR MONITORING THE CIRCULATION OF GOODS SUBJECT TO MANDATORY LABELING WITH IDENTIFICATION MEANS IN RESPECT OF CERTAIN TYPES OF MEDICAL DEVICES<\/strong><\/h4>\n

(as amended by Resolutions of the Government of the Russian Federation dated March 29, 2024 No. 392, dated May 31, 2024 No. 743, dated June 26, 2024 No. 860, dated November 26, 2024 No. 1630, dated September 12, 2025 No. 1409)<\/em><\/p>\n

 <\/p>\n

 <\/p>\n

The Government of the Russian Federation resolves:<\/p>\n

    \n
  1. To approve the annexed Rules for labeling certain types of medical devices by means of identification.<\/li>\n
  2. To establish that participants in the circulation of certain types of medical devices, in accordance with the Rules approved by this Resolution:<\/li>\n
  3. a) shall submit to the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Labeling by Means of Identification (hereinafter \u2014 the information monitoring system) an application for their registration in the information monitoring system starting from September\u00a01, 2023, but no later than 7\u00a0calendar days from the date of emergence of the necessity for a participant in the circulation of certain types of medical devices to carry out activities related to the introduction into circulation, and\/or circulation, and\/or withdrawal from circulation of certain types of medical devices in respect of which a prohibition on the introduction into circulation, and\/or circulation, and\/or withdrawal from circulation of certain types of medical devices without labeling by means of identification has been established (with the exception of participants in the circulation of certain types of medical devices falling under the provisions of paragraphs\u00a03 and\u00a07 of Article\u00a02 of the Federal Law \u201cOn the Use of Cash Registers in Settlements in the Russian Federation\u201d (hereinafter \u2014 participants in the circulation of certain types of medical devices in remote or hard\u2011to\u2011reach areas).<\/li>\n<\/ol>\n

    At the same time, participants in the circulation of certain types of medical devices in remote or hard\u2011to\u2011reach areas shall carry out registration in the information monitoring system within 30\u00a0calendar days from the date of emergence of the necessity for them to carry out activities related to the introduction into circulation, and\/or circulation, and\/or withdrawal from circulation of certain types of medical devices;<\/p>\n

      \n
    1. b) shall ensure, no later than 15\u00a0calendar days from the date of registration in the information monitoring system, the readiness of their own hardware and software for information interaction with the information monitoring system and shall submit to the operator of the information monitoring system an application for passing the testing of information interaction in electronic form;<\/li>\n
    2. c) for the purpose of carrying out work to ensure the readiness of their own hardware and software for information interaction with the information monitoring system and for passing the testing of information interaction in electronic form after registration in the information monitoring system, shall submit in electronic form to the operator of the information monitoring system an application for the provision of remote access to the emission registration device located in the infrastructure of the information monitoring system;<\/li>\n
    3. d) shall pass the testing of information interaction between their own hardware and software and the information monitoring system in accordance with the procedure posted on the official website of the operator of the information monitoring system on the information and telecommunication network \u201cInternet\u201d, in respect of operations related to the labeling of certain types of medical devices, their introduction into circulation, circulation and withdrawal from circulation, in accordance with the Rules approved by this Resolution, no later than 15\u00a0calendar days from the date of readiness of their own hardware and software for information interaction with the information monitoring system and the submission of the application in accordance with subparagraph\u00a0\u201cb\u201d of this paragraph.<\/li>\n
    4. To establish that:<\/li>\n
    5. a) participants in the circulation of certain types of medical devices having a valid registration certificate for a medical device, who carry out the introduction into circulation of certain types of medical devices, shall apply means of identification to the consumer packaging, including by applying to such consumer packaging a label containing the means of identification, to the said certain types of medical devices and shall submit to the information monitoring system information on the application of means of identification and the introduction into circulation of the said certain types of medical devices in accordance with the Rules approved by this Resolution:<\/li>\n<\/ol>\n

      in respect of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), orthopedic footwear and insert corrective elements for orthopedic footwear (including insoles, half\u2011insoles) (codes of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union 8421 39 200 8, 8421 39 800 6, 8539 49 000 0, 9018 20 000 0, 9021 10 100 0, codes of the All\u2011Russian Classifier of Products by Types of Economic Activity 28.25.14.110, 32.50.22.150, 32.50.22.151, 32.50.22.152, 32.50.22.155, 32.50.22.156, 32.50.22.157, 32.50.50.190, codes of the type of medical device in accordance with the nomenclature classification of medical devices 131980, 152690, 152700, 182750, 209360, 250220, 250230, 250250, 250260, 292620, 320560, 336330, 343610, 375930) \u2014 from October 1, 2023;<\/p>\n

      in respect of hearing aids, other than parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence (codes of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union 9021 40 000 0, 9021 90 900 1, 9022 12 000 0, 9022 13 000 0, 9022 14 000 0, 9022 19 000 0, 9619 00 890, codes of the All\u2011Russian Classifier of Products by Types of Economic Activity 17.22.12.130, 26.60.11.111, 26.60.11.113, 26.60.11.119, 26.60.14.120, 32.50.22.190, 32.50.22.195, codes of the type of medical device in accordance with the nomenclature classification of medical devices 113850, 126750, 135190, 135820, 142570, 155760, 155800, 155820, 173110, 202800, 202810, 204370, 210000, 218190, 228560, 233730, 233860, 233900, 273880, 280360, 280730, 282030, 302870, 320550, 331320, 331330, 331830, 343410, 343540, 343580, 356150) \u2014 from March 1, 2024.<\/p>\n

      At the same time, participants in the circulation of certain types of medical devices who carry out the introduction into circulation of the said certain types of medical devices, from the date of entry into force of this Resolution, shall have the right to apply means of identification to the consumer packaging, including by applying to such consumer packaging a label containing the means of identification, to the certain types of medical devices specified in the second and third paragraphs of this subparagraph, subject to submission to the information monitoring system of information on the application of means of identification and the introduction into circulation of the said certain types of medical devices in accordance with the Rules approved by this Resolution, and shall also have the right to submit to the information monitoring system information on the circulation and withdrawal from circulation of certain types of medical devices in accordance with the Rules approved by this Resolution, taking into account the requirements of paragraph 9 of this Resolution;<\/p>\n

      ) participants in the circulation of certain types of medical devices shall submit to the information monitoring system, in accordance with the Rules approved by this Resolution, information on the withdrawal from circulation of certain types of medical devices from September 1, 2024, information on the circulation of certain types of medical devices (with the exception of sanitary and hygienic products used for incontinence) in accordance with the Rules approved by this Resolution, from September 1, 2025, information on the circulation of sanitary and hygienic products used for incontinence in accordance with the Rules approved by this Resolution, from March 1, 2026 (as amended by Resolution of the Government of the Russian Federation of September 12, 2025 No. 1409).<\/p>\n

      At the same time, participants in the circulation of certain types of medical devices shall have the right to submit to the information monitoring system information on the circulation and withdrawal from circulation of certain types of medical devices in accordance with the Rules approved by this Resolution, from the date of entry into force of this Resolution;<\/p>\n

        \n
      1. c) participants in the circulation of certain types of medical devices in remote or hard\u2011to\u2011reach areas shall have the right to submit the information specified in Section VIII of the Rules approved by this Resolution within 30 calendar days:<\/li>\n<\/ol>\n

        from the date of shipment (transfer or acceptance) of certain types of medical devices upon the transfer (acceptance) of certain types of medical devices within the framework of transactions providing for the transfer of ownership rights to the said goods, as well as within the framework of commission agreements, and\/or agency agreements, and\/or contractor agreements, and\/or mandate agreements;<\/p>\n

        from the date of withdrawal of certain types of medical devices from circulation upon the withdrawal of certain types of medical devices from circulation;<\/p>\n

        from the date of return of certain types of medical devices into circulation in the event of such return;<\/p>\n

        from the date of modification of the information provided for by Sections III, IV, VIII and IX of the Rules approved by this Resolution, in the event of modification of such information;<\/p>\n

          \n
        1. d) participants in the circulation of certain types of medical devices shall carry out the labeling of certain types of medical devices imported (brought in) and placed under the customs procedures of release for domestic consumption or re\u2011import, prior to the offering of these certain types of medical devices for sale (retail) and shall enter into the information monitoring system information on the labeling of such certain types of medical devices by means of identification in accordance with the Rules approved by this Resolution:<\/li>\n<\/ol>\n

          in respect of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), orthopedic footwear and insert corrective elements for orthopedic footwear (including insoles, half\u2011insoles), purchased through September 30, 2023 (inclusive) and released by customs authorities starting from October 1, 2023 through October 31, 2023 (inclusive);<\/p>\n

          in respect of hearing aids, other than parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, purchased through February 29, 2024 (inclusive) and released by customs authorities starting from March 1, 2024 through March 31, 2024 (inclusive);<\/p>\n

            \n
          1. e) participants in the circulation of certain types of medical devices, in the presence on the territory of the Russian Federation of unsold certain types of medical devices, shall have the right to carry out the sale of such medical devices without labeling by means of identification until the expiration of their shelf life (with the exception of certain types of medical devices having a service life) or to carry out labeling by means of identification of such medical devices and to submit information on the labeling of certain types of medical devices by means of identification to the information monitoring system in accordance with the Rules approved by this Resolution, through August 31, 2024 (inclusive):<\/li>\n<\/ol>\n

            in respect of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), orthopedic footwear and insert corrective elements for orthopedic footwear (including insoles, half\u2011insoles), introduced into circulation through September 30, 2023 (inclusive) and not sold as of October 1, 2023;<\/p>\n

            in respect of hearing aids, other than parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, introduced into circulation through February 29, 2024 (inclusive) and not sold as of March 1, 2024.<\/p>\n

            Participants in the circulation of certain types of medical devices having a service life, in the presence on the territory of the Russian Federation of such unsold certain types of medical devices, shall have the right to carry out the sale of such medical devices without labeling by means of identification or to carry out their labeling by means of identification and to submit information on the labeling of such certain types of medical devices by means of identification to the information monitoring system in accordance with the Rules approved by this Resolution, through August 31, 2024 (inclusive): (as amended by Resolution of the Government of the Russian Federation of March 29, 2024 No. 392)<\/p>\n

            in respect of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), orthopedic footwear and insert corrective elements for orthopedic footwear (including insoles, half\u2011insoles), introduced into circulation through September 30, 2023 (inclusive) and not sold as of October 1, 2023;<\/p>\n

            in respect of hearing aids, other than parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, introduced into circulation through February 29, 2024 (inclusive) and not sold as of March 1, 2024.<\/p>\n

            At the same time, participants in the circulation of certain types of medical devices having a service life, who acquired such medical devices for the purpose of carrying out activities in the field of healthcare and the provision of social and medical services, shall have the right to carry out storage, transportation and gratuitous transfer of such medical devices provided for by the fifth and sixth paragraphs of this subparagraph, without labeling by means of identification, and the sale (retail) of such medical devices in accordance with the fourth paragraph of this paragraph. (as amended by Resolution of the Government of the Russian Federation of March 29, 2024 No. 392)<\/p>\n

            In the cases specified in the first and\/or fourth paragraphs of this subparagraph, a participant in the circulation of certain types of medical devices shall register such medical devices in the subsystem of the national catalog of labeled goods of the information monitoring system and shall specify the information provided for by paragraphs 37\u201341 of the Rules approved by this Resolution, shall ensure their labeling, and shall also submit information on their labeling by means of identification to the information monitoring system in accordance with the Rules approved by this Resolution.<\/p>\n

            Payment for the labeling codes necessary for the formation of means of identification of certain types of medical devices specified in the first and fourth paragraphs of this subparagraph shall be carried out in accordance with the Rules approved by this Resolution.<\/p>\n

              \n
            1. Registration in the information system used for the purpose of ensuring the conduct of the experiment in accordance with the Resolution of the Government of the Russian Federation of February 9, 2022 No. 137 “On the Conduct on the Territory of the Russian Federation of an Experiment on Labeling Certain Types of Medical Devices by Means of Identification” (hereinafter \u2014 the experiment), of legal entities and individual entrepreneurs who as of August 31, 2023 were participants in the experiment, shall be equated to registration in the information monitoring system in accordance with subparagraph “a” of paragraph 2 of this Resolution.<\/li>\n<\/ol>\n

              In the event that the information submitted within the framework of the experiment by participants in the circulation of certain types of medical devices to the information system in which the information support of the conduct of the experiment is carried out does not meet the requirements of the Rules approved by this Resolution, participants in the circulation of certain types of medical devices shall submit to the information monitoring system the missing and\/or updated information through September 30, 2023 (inclusive).<\/p>\n

                \n
              1. To establish that the operator of the information monitoring system ensures:<\/li>\n
              2. a) the organization of testing of information interaction between the hardware and software of participants in the circulation of certain types of medical devices and the information monitoring system no later than 15 calendar days from the date of receipt from participants in the circulation of certain types of medical devices registered in the information monitoring system of a notification of readiness for information interaction with the information monitoring system;<\/li>\n
              3. b) the provision to participants in the circulation of certain types of medical devices of remote access to emission registration devices located in the infrastructure of the information monitoring system, under the conditions provided for by the Rules approved by this Resolution, no later than 30 calendar days from the date of receipt from participants in the circulation of certain types of medical devices registered in the information monitoring system of an application in electronic form for the provision of remote access to the emission registration device.<\/li>\n
              4. To establish that on the territory of the Russian Federation the introduction into circulation of certain types of medical devices without application to the consumer packaging, including by applying to such consumer packaging a label containing the means of identification, of certain types of medical devices and without submission to the information monitoring system of information on the labeling of certain types of medical devices by means of identification is permitted until the dates established by subparagraphs “a” and “e” of paragraph 3 of this Resolution, from which the application of means of identification to the consumer packaging, including by applying to such consumer packaging a label containing the means of identification, of such certain types of medical devices and the submission to the information monitoring system of information become mandatory, with the exception of the cases specified in the first paragraph of subparagraph “d” and the first paragraph of subparagraph “i” of paragraph 3 of this Resolution. (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n<\/ol>\n

                The circulation and withdrawal from circulation of unlabeled certain types of medical devices manufactured in the Russian Federation or imported (brought in) into the Russian Federation in the event of importation from the territory of the Eurasian Economic Union within the framework of cross-border trade or release by customs authorities upon their placement under the customs procedures of release for domestic consumption or re-import of unlabeled certain types of medical devices (in the event of their manufacture outside the Russian Federation), are permitted until the expiration of the shelf life of certain types of medical devices (with the exception of certain types of medical devices which have a service life, which are labeled in accordance with the requirements of the fourth paragraph of subparagraph “d” and the first paragraph of subparagraph “i” of paragraph 3 of this Resolution). (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/p>\n

                The release by customs authorities of imported (brought in) unlabeled certain types of medical devices placed under the customs procedures of release for domestic consumption or re-import, specified in subparagraphs “g” and “z” of paragraph 3 of this Resolution, is permitted: (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/p>\n

                in respect of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), orthopedic footwear and insert corrective elements for orthopedic footwear (including insoles, half-insoles) \u2014 through October 31, 2023 (inclusive);<\/p>\n

                in respect of hearing aids, other than parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence \u2014 through March 31, 2024 (inclusive);<\/p>\n

                in respect of medical gloves \u2014 through March 31, 2025 (inclusive). (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/p>\n

                  \n
                1. This Resolution shall not apply to certain types of medical devices in respect of which, in accordance with the Rules approved by this Resolution and international treaties of the Russian Federation, the requirements for mandatory labeling by means of identification do not apply.<\/li>\n
                2. To establish that from October 1, 2023 the provision to a participant in the circulation of certain types of medical devices of labeling codes necessary for the formation of means of identification shall be carried out by the operator of the information monitoring system on a paid basis in accordance with the Rules approved by this Resolution.<\/li>\n
                3. From the date of entry into force of this Resolution, at the decision of a participant in the circulation of certain types of medical devices, the provision to such participant of labeling codes necessary for the formation of means of identification may be carried out by the operator of the information monitoring system prior to the corresponding date established by paragraph 3 of this Resolution, from which the application of means of identification to the consumer packaging of certain types of medical devices becomes mandatory. Such labeling codes shall be provided by the operator of the information monitoring system on a gratuitous basis. At the same time, a participant in the circulation of certain types of medical devices that has received labeling codes on a gratuitous basis shall ensure their conversion into means of identification and shall submit to the information monitoring system a report on the application of means of identification and information on the introduction into circulation of certain types of medical devices through September 30, 2023 (inclusive).<\/li>\n<\/ol>\n

                  The service for the provision of a labeling code in the case provided for by the first paragraph of this paragraph shall be deemed to have been rendered by the operator of the information monitoring system at the moment of entry by the operator of the information monitoring system into the information monitoring system of information on the introduction of certain types of medical devices into circulation, as specified by the participant in the circulation of certain types of medical devices in the notification on the introduction of the corresponding certain types of medical devices into circulation.<\/p>\n

                  At the same time, the operator of the information monitoring system shall enter into the information monitoring system information on the introduction into circulation of certain types of medical devices after receipt from the participant in the circulation of certain types of medical devices of a report on the application of means of identification.<\/p>\n

                  In the event that a participant in the circulation of certain types of medical devices that has received labeling codes on a gratuitous basis has not ensured their conversion into means of identification and has not submitted to the information monitoring system a report on the application of means of identification and information on the introduction into circulation of certain types of medical devices through September 30, 2023 (inclusive), such labeling codes shall be paid for by the participant in the circulation of certain types of medical devices or cancelled in accordance with the Rules approved by this Resolution.<\/p>\n

                    \n
                  1. The application of means of identification to the consumer packaging of certain types of medical devices, including by applying to such consumer packaging a label containing the means of identification, does not require the introduction of amendments to the documents contained in the registration dossier for the medical device, in the procedure established by paragraphs 37\u201351 of the Rules for State Registration of Medical Devices approved by the Resolution of the Government of the Russian Federation of December 27, 2012 No. 1416 “On Approval of the Rules for State Registration of Medical Devices”.<\/li>\n
                  2. This Resolution shall enter into force on September 1, 2023.<\/li>\n<\/ol>\n

                     <\/p>\n

                     <\/p>\n

                    Chairman of the Government<\/em><\/p>\n

                    of the Russian Federation<\/em><\/p>\n

                      \n
                    1. Mishustin<\/em><\/li>\n<\/ol>\n

                      \u00a0<\/em><\/p>\n

                      \u00a0<\/em><\/p>\n

                      APPROVED by Resolution No. 894 of the Government<\/em><\/p>\n

                      of the Russian Federation dated May 31, 2023<\/em><\/p>\n

                      RULES FOR LABELING CERTAIN TYPES OF MEDICAL DEVICES BY MEANS OF IDENTIFICATION<\/strong><\/p>\n

                      (as amended by Resolutions of the Government of the Russian Federation of May 31, 2024 No. 743, of June 26, 2024 No. 860, of November 26, 2024 No. 1630, of September 12, 2025 No. 1409)<\/em><\/p>\n

                        \n
                      1. General Provisions<\/strong><\/li>\n
                      2. These Rules determine the procedure for labeling certain types of medical devices subject to mandatory labeling by means of identification, the requirements for participants in the circulation of certain types of medical devices, the procedure for information exchange between participants in the circulation of certain types of medical devices and the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Labeling by Means of Identification (hereinafter \u2014 the information monitoring system), the characteristics of the means of identification, as well as the procedure for submission by participants in the circulation of certain types of medical devices of information to the information monitoring system on the introduction into circulation, circulation and withdrawal from circulation of certain types of medical devices.<\/li>\n
                      3. The concepts used in these Rules mean the following:<\/li>\n<\/ol>\n

                        “aggregation” \u2014 the process of combining goods in consumer packaging into group packaging, or into a set, or into transport packaging, or group packaging into transport packaging or sets into transport packaging, or transport packaging into transport packaging of a higher nesting level, with preservation of information on the relationship of the identification codes of each nested unit of goods in consumer packaging with the identification code of the group packaging being created and\/or transport packaging or with the identification code of the set being created and\/or transport packaging, on the relationship of the identification codes of each nested group packaging with the identification code of the transport packaging being created or the identification codes of each nested set with the identification code of the transport packaging being created, as well as on the relationship of the identification codes of each nested transport packaging with the identification code of the transport packaging of a higher nesting level being created, and the application of the corresponding means of identification to the group packaging or set or the identification code of transport packaging for the purpose of ensuring the traceability of the movement of goods along the distribution chain without the need to open the group and\/or transport packaging being created or the set and\/or transport packaging being created;<\/p>\n

                        “aggregated customs code” \u2014 a unique sequence of characters for each separate set of goods, representing a combination of identification codes, including identification codes of packaging combining goods in the process of aggregation, generated by the operator of the information monitoring system for the purpose of identification of goods in accordance with these Rules, used by a participant in the circulation of goods in the customs declaration of goods. At the same time, the combination of identification codes of goods, a part of which is already included in the identification code of group or transport packaging or in another aggregated customs code, is not permitted;<\/p>\n

                        “validation of a means of identification” \u2014 assessment of the quality of the conversion of a labeling code into a means of identification and its application to the subject of compliance of its structure with the requirements of these Rules;<\/p>\n

                        “introduction of goods into circulation”:<\/p>\n

                        in the manufacture of goods on the territory of the Russian Federation (including in cases of contract manufacturing), including cases of manufacture of goods from foreign raw materials and\/or components placed under the customs procedure of a free customs zone or under the customs procedure of a free warehouse \u2014 the submission by a participant in the circulation of goods to the information monitoring system of a notification of the primary paid or gratuitous transfer of goods from the manufacturer to a new owner or to another person for the purpose of alienation to such person or subsequent sale (retail, including retail), which makes the goods available for distribution and\/or use, or the submission to the information monitoring system of a notification of the introduction of goods into circulation by the manufacturer or a third-party manufacturer of goods with the submission to the information monitoring system of information in accordance with paragraph 77 of these Rules;<\/p>\n

                        in the manufacture of goods outside the territory of the Russian Federation (with the exception of goods imported from member states of the Eurasian Economic Union) \u2014 the release by customs authorities of goods imported (brought in) into the Russian Federation in accordance with the customs procedures of release for domestic consumption or re-import and the submission by a participant in the circulation of goods to the information monitoring system of a notification of the introduction of goods into circulation in accordance with paragraph 78 of these Rules;<\/p>\n

                        in the manufacture of goods outside the territory of the Russian Federation in respect of goods imported from member states of the Eurasian Economic Union within the framework of cross-border trade on the customs territory of the Eurasian Economic Union \u2014 the importation into the Russian Federation by a participant in the circulation of goods and the submission to the information monitoring system by a participant in the circulation of goods of a notification of the introduction of goods into circulation with the submission to the information monitoring system of information in accordance with paragraph 81 of these Rules;<\/p>\n

                        paid or gratuitous transfer to a new owner of goods acquired by participants in the circulation of goods in the established manner upon the sale of property, as a result of the conduct of auctions within the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in the manner of administrative or criminal proceedings, as well as as a result of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation, the submission to the information monitoring system by a participant in the circulation of goods of a notification of the introduction of goods into circulation in accordance with paragraph 86 of these Rules;<\/p>\n

                        sale (retail) of goods by a participant in the circulation of goods under a transaction not containing information constituting a state secret, of goods previously acquired under a transaction, information about which constitutes a state secret, and the submission to the information monitoring system by a participant in the circulation of goods of a notification of the introduction of goods into circulation in accordance with paragraph 113 of these Rules;<\/p>\n

                        paid or gratuitous transfer by participants in the circulation of goods to a new owner of goods previously acquired by them for purposes not related to their subsequent sale (retail) (for their own needs, production purposes, use within the framework of marketing campaigns on the territory of the Russian Federation, use within the framework of charitable activities) (hereinafter \u2014 purposes not related to their subsequent sale (retail), and the submission to the information monitoring system by a participant in the circulation of goods of a notification of the introduction of goods into circulation in accordance with paragraph 116 of these Rules;<\/p>\n

                        sale (retail) of unsold as of October 1, 2023 residual goods by a participant in the circulation of goods within the framework of transactions providing for the transfer of ownership rights to the said goods, as well as within the framework of commission agreements, and\/or agency agreements, and\/or contractor agreements, and\/or mandate agreements, and the submission to the information monitoring system by a participant in the circulation of goods of a notification of the introduction of goods into circulation in accordance with paragraph 117 of these Rules;<\/p>\n

                        “withdrawal of goods from circulation”:<\/p>\n

                        sale (retail) or other transfer of labeled goods to an individual for personal consumption on the basis of contracts providing for the transfer of ownership rights to goods, including retail sale, gratuitous transfer, assignment of rights, set-off or novation;<\/p>\n

                        sale (retail) of goods to legal entities, accredited branches of foreign legal entities in the Russian Federation (hereinafter \u2014 branches of foreign legal entities) and individuals registered as individual entrepreneurs (hereinafter \u2014 individual entrepreneur), for purposes not related to the subsequent sale (retail) of such goods;<\/p>\n

                        seizure (confiscation), write-off (disposal) (including in connection with the availability of information letters from the Federal Service for Surveillance in Healthcare on the detection in circulation of a poor-quality, unregistered, falsified medical device), destruction or irretrievable loss of goods;<\/p>\n

                        sale (retail) of labeled goods outside the Russian Federation;<\/p>\n

                        sale (retail) of goods under a transaction, information about which constitutes a state secret;<\/p>\n

                        sale (retail) of goods by selling them by sample or remotely upon shipment of goods from the storage warehouse for delivery to the consumer;<\/p>\n

                        use of goods for purposes not related to their subsequent sale (retail);<\/p>\n

                        offering for sale (retail) of goods by means of a vending machine or parcel locker upon shipment of goods from the storage warehouse for delivery to the vending machine or parcel locker;<\/p>\n

                        supply of labeled goods within the framework of the execution of contracts concluded in accordance with the Federal Law “On the Contract System in the Sphere of Procurement of Goods, Works, Services for the Provision of State and Municipal Needs” (hereinafter \u2014 the Federal Law on the Contract System), with the exception of the supply of labeled goods to participants in the circulation of goods acquiring such goods not for retail sale, but for the purpose of carrying out activities in the field of healthcare and the provision of social and medical services;<\/p>\n

                        “group packaging” \u2014 packaging labeled with a means of identification, combining a certain quantity of goods in consumer packaging with the same product code, labeled with means of identification, which can be broken down or sold to the consumer in unchanged form;<\/p>\n

                        “importer” \u2014 a legal entity, a branch of a foreign legal entity or an individual entrepreneur carrying out the importation of goods into the Russian Federation, with the exception of cases of transit movement of such goods through the territory of the Russian Federation;<\/p>\n

                        “individual serial number” \u2014 a sequence of characters uniquely identifying a unit of goods (goods in consumer packaging, or group packaging, or a set) on the basis of the product code;<\/p>\n

                        “electronic interaction interface” \u2014 a set of means and rules ensuring the interaction of hardware and software of participants in the circulation of goods and the information monitoring system;<\/p>\n

                        “corrected universal transfer document” \u2014 an electronic primary document on the shipment of goods (on the performance of works, on the provision of services), on the transfer of property rights, created by participants in the circulation of goods when correcting a previously drawn up document by participants in the circulation of goods that contained errors;<\/p>\n

                        “identification code of group packaging” \u2014 a sequence of characters representing a unique number of group packaging, generated for the purpose of identification of goods in group packaging in accordance with the requirements provided for by Section V of these Rules;<\/p>\n

                        “identification code of a set” \u2014 a sequence of characters representing a unique number of an instance of a set, generated for the purpose of identification of a set in accordance with Section V of these Rules;<\/p>\n

                        “identification code of transport packaging” \u2014 a sequence of characters representing a unique number of transport packaging, generated in accordance with Section V of these Rules;<\/p>\n

                        “contract manufacturing” \u2014 the manufacture of goods by a third-party manufacturer of goods on the basis of a contract with a participant in the circulation of goods using a trademark registered in the name of such participant in the circulation of goods (the trademark rights holder) or a trademark of a third party in respect of which the participant in the circulation of goods has the right of use;<\/p>\n

                        “labeled goods” \u2014 goods on the consumer packaging of which, including by applying to such consumer packaging a label containing the means of identification, means of identification have been applied in compliance with the requirements of these Rules and reliable information about which (including information on the means of identification applied to the consumer packaging, including by applying to such consumer packaging a label containing the means of identification, of the said goods) is contained in the information monitoring system;<\/p>\n

                        “labeling of goods” \u2014 the application in accordance with these Rules of means of identification to the consumer packaging of goods, including by applying to such consumer packaging a label containing the means of identification;<\/p>\n

                        “set” \u2014 a combination of goods with different product codes in consumer packaging, each of which is subject to mandatory labeling by means of identification, has an identification code, generated by participants in the circulation of goods at any stage, having an identification code of a set and subject to sale (retail) to the consumer;<\/p>\n

                        “operator of the information monitoring system” \u2014 a legal entity registered on the territory of the Russian Federation, carrying out the creation, development, modernization and operation of the information monitoring system, ensuring its uninterrupted functioning, as well as the receipt, storage and processing of information;<\/p>\n

                        “operator of the national information system for labeling” \u2014 competent (authorized) bodies of the member states of the Eurasian Economic Union, which include the executive bodies of the member states of the Eurasian Economic Union, authorized in accordance with the legislation of a member state of the Eurasian Economic Union to ensure control over the circulation of goods, and\/or interdepartmental coordination of the activities of the executive bodies of the member states of the Eurasian Economic Union on control over the circulation of goods, and\/or the functioning of the national component of the information system for labeling goods by means of identification, and\/or coordination of activities to ensure its functioning, as well as private operators authorized by the said competent (authorized) bodies of the member states of the Eurasian Economic Union;<\/p>\n

                        “relabeling” \u2014 repeated application of means of identification to consumer packaging, including by applying to such consumer packaging a label containing the means of identification, in connection with the loss or damage of previously applied means of identification;<\/p>\n

                        “subsystem of the national catalog of labeled goods” \u2014 a subsystem of the information monitoring system used for cataloging and storing information about labeled goods and being a single source of the product code;<\/p>\n

                        “consumer packaging” \u2014 packaging intended for sale or primary packaging of goods sold to the end consumer;<\/p>\n

                        “offering of goods for sale (retail)” \u2014 the provision by the seller to the buyer of goods (samples of goods) for direct familiarization, including by displaying them at the place of sale (retail). The provision by the seller to the buyer of a description of the goods upon remote sale, which is contained in catalogs, prospectuses, booklets or is presented in photographs, or using postal communication networks, telecommunication networks, including the information and telecommunication network “Internet” (hereinafter \u2014 the “Internet” network), as well as communication networks for broadcasting television channels and\/or radio channels, or by other methods precluding the possibility of direct familiarization of the buyer with the goods or a sample of goods upon the conclusion of a purchase and sale contract, is not an offer for sale (retail);<\/p>\n

                        “manufacturer” \u2014 a legal entity, or a branch of a foreign legal entity, or an individual entrepreneur, being tax residents of the Russian Federation, who carry out the manufacture and sale (retail) of goods on the territory of the Russian Federation;<\/p>\n

                        “data transfer protocol” \u2014 a formalized set of requirements for the structure of information packets and the algorithm for the exchange of information packets between devices of a data transmission network;<\/p>\n

                        “service provider” \u2014 a legal entity carrying out, on behalf of a participant in the circulation of goods, the conversion of a labeling code into a means of identification and\/or the application of a means of identification to consumer packaging, and\/or group packaging, and\/or a set, and\/or a label;<\/p>\n

                        “means of identification” \u2014 a labeling code in machine-readable form, represented as a barcode, generated in accordance with Sections V and VI of these Rules, for application to consumer packaging, and\/or group packaging, and\/or a set, and\/or a label;<\/p>\n

                        “status of the identification code, identification code of group packaging, identification code of a set, identification code of transport packaging, aggregated customs code” \u2014 the state of the identification code, identification code of group packaging, identification code of a set, identification code of transport packaging, aggregated customs code, as determined in the information monitoring system, which changes within the framework of the processes provided for by these Rules, the possible statuses of which are provided for by paragraph 5 of these Rules;<\/p>\n

                        “third-party manufacturer of goods” \u2014 a legal entity, or a branch of a foreign legal entity, or an individual entrepreneur, being tax residents of the Russian Federation, who carry out the manufacture and transfer of goods to the manufacturer within the framework of contract manufacturing;<\/p>\n

                        “goods” \u2014 certain types of medical devices having a valid registration certificate, in respect of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), orthopedic footwear and insert corrective elements for orthopedic footwear (including insoles, half-insoles), hearing aids, other than parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, medical gloves, corresponding to the codes of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (hereinafter \u2014 the commodity nomenclature) 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, 8421 39 200 8, 8421 39 800 6, 8539 49 000 0, 9018 20 000 0, 9021 10 100 0, 9021 40 000 0, 9021 90 900 1, 9022 12 000 0, 9022 13 000 0, 9022 14 000 0, 9022 19 000 0, 9619 00 890, codes of the All-Russian Classifier of Products by Types of Economic Activity 14.12.30.160, 17.22.12.130, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 26.60.11.111, 26.60.11.113, 26.60.11.119, 26.60.14.120, 28.25.14.110, 32.50.13.190, 32.50.22.150, 32.50.22.151, 32.50.22.152, 32.50.22.155, 32.50.22.156, 32.50.22.157, 32.50.22.190, 32.50.22.195, 32.50.50.190 and codes of the type of medical device in accordance with the nomenclature classification of medical devices 113850, 122540, 122560, 122610, 122630, 122640, 126750, 129800, 129900, 130220, 131980, 135190, 135820, 139310, 139350, 139360, 142570, 152690, 152700, 155760, 155800, 155820, 156530, 169840, 173110, 182750, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 202800, 202810, 204370, 205280, 205290, 209360, 210000, 218190, 228560, 233730, 233860, 233900, 250220, 250230, 250250, 250260, 257300, 273880, 280360, 280730, 282030, 292620, 298450, 302870, 311720, 316120, 318420, 320550, 320560, 320790, 321530, 322780, 323740, 326340, 329770, 331320, 331330, 331830, 336330, 343410, 343540, 343580, 343610, 349230, 351490, 356150, 375930, 388560; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/p>\n

                        “transport packaging” \u2014 transport packaging combining goods in consumer packaging, and\/or group packaging, and\/or sets, used for the storage and transportation of goods for the purpose of protecting them from damage during movement and forming an independent transport unit. Transport packaging may include transport packaging of a smaller size (volume). At the same time, packaging combining only goods in consumer packaging, and\/or group packaging, and\/or sets is recognized as transport packaging of the first level, and subsequent transport packaging of various degrees of nesting, starting from packaging containing exclusively transport packaging of the first level, is recognized as transport packaging of the subsequent (second, third, etc.) level;<\/p>\n

                        “notification of the introduction of goods into circulation” \u2014 an electronic document generated by a participant in the circulation of goods in the information monitoring system and containing the information specified in paragraphs 77, 78, 81, 86, 113, 116 and 117 of these Rules;<\/p>\n

                        “universal correction document” \u2014 an electronic document confirming the consent (fact of notification) of the buyer to a change in the value of shipped goods (performed works, provided services), transferred property rights, the format of which is approved by the federal executive body authorized for control and supervision in the field of taxes and fees;<\/p>\n

                        “universal transfer document” \u2014 an electronic primary document on the shipment of goods (on the performance of works, on the provision of services), on the transfer of property rights, the format of which is approved by the federal executive body authorized for control and supervision in the field of taxes and fees;<\/p>\n

                        “participants in the circulation of goods” \u2014 legal entities and individual entrepreneurs, as well as branches of foreign legal entities, being tax residents of the Russian Federation, carrying out the introduction of goods into circulation, circulation and\/or withdrawal from circulation of goods, with the exception of legal entities, individual entrepreneurs and branches of foreign legal entities:<\/p>\n

                        acquiring goods for use for purposes not related to their subsequent sale (retail) (except in cases of importation of goods by importers into the Russian Federation, as well as the acquisition of goods for the purpose of use for carrying out activities in the field of healthcare and the provision of social and medical services);<\/p>\n

                        providing, upon the sale of goods by sample or remotely, postal communication services in respect of postal items with cash on delivery, or goods delivery services to consumers, or acting as payment agents not carrying out the circulation of labeled goods (the exception does not apply to legal entities, branches of foreign legal entities and individual entrepreneurs, including those who are owners of aggregators of information about goods (services), when they provide in respect of a single unit of goods a complex of services for warehouse storage, assembling and\/or packaging, including with the involvement of third parties);<\/p>\n

                        acquiring or selling (retailing) goods under a transaction, information about which constitutes a state secret (except for persons carrying out the withdrawal of goods from circulation under such transactions);<\/p>\n

                        “label” \u2014 an information carrier intended for the application of information about goods, and\/or means of identification, attached directly to consumer packaging, and\/or group packaging, and\/or set packaging, including by gluing.<\/p>\n

                        Other concepts used in these Rules are applied in the meanings defined by the legislation of the Russian Federation in the sphere of mandatory labeling of goods by means of identification.<\/p>\n

                          \n
                        1. The provisions of these Rules, in addition to the cases provided for by paragraph 3 of the Rules for Labeling Goods Subject to Mandatory Labeling by Means of Identification, approved by the Resolution of the Government of the Russian Federation of April 26, 2019 No. 515 “On the System for Labeling Goods by Means of Identification and Traceability of the Movement of Goods” (hereinafter \u2014 the Rules for Labeling of Goods), do not apply to:<\/li>\n
                        2. a) goods placed under customs procedures for the purpose of their export beyond the customs territory of the Eurasian Economic Union;<\/li>\n
                        3. b) goods imported into the Russian Federation or manufactured on the territory of the Russian Federation by participants in the circulation of goods as promotional, marketing samples not intended for sale (retail);<\/li>\n
                        4. c) goods acquired under a transaction, information about which constitutes a state secret, during their transportation by a participant in such transaction through the territory of the Russian Federation;<\/li>\n
                        5. d) goods not subject to state registration on the basis of Part 5 of Article 38 of the Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”.<\/li>\n
                        6. The operator of the information monitoring system shall have the right to provide labeling codes to operators of national information systems for labeling. The labeling codes must be used by participants in the circulation of goods of the member states of the Eurasian Economic Union for labeling by means of identification of goods imported into the Russian Federation.<\/li>\n<\/ol>\n

                          The receipt of labeling codes by operators of national information systems for labeling is carried out by means of the exchange of information with the operator of the information monitoring system in the procedure established by the Resolution of the Board of the Eurasian Economic Commission of July 13, 2022 No. 100.<\/p>\n

                          For the purpose of receiving labeling codes, operators of national information systems for labeling shall conclude with the operator of the information monitoring system a contract for the provision of services for the provision of labeling codes.<\/p>\n

                            \n
                          1. The following statuses of the identification code, identification code of group packaging, identification code of a set, identification code of transport packaging, aggregated customs code are possible in the information monitoring system:<\/li>\n
                          2. a) for the identification code, identification code of group packaging, identification code of a set:<\/li>\n<\/ol>\n

                            “issued” \u2014 the identification code as part of the labeling code has been provided by the operator of the information monitoring system to a participant in the circulation of goods for the purpose of labeling goods by means of identification, the corresponding goods have not been introduced into circulation;<\/p>\n

                            “in circulation” \u2014 the identification code as part of the labeling code has been provided by the operator of the information monitoring system to a participant in the circulation of goods, the corresponding goods have been labeled by means of identification, introduced into circulation and are in circulation.<\/p>\n

                            For the identification code of goods manufactured outside the territory of the Russian Federation (with the exception of goods imported from member states of the Eurasian Economic Union), the status “in circulation” is established after the release by customs authorities of goods imported (brought in) into the Russian Federation and placed under customs procedures of release for domestic consumption or re-import, and the submission by a participant in the circulation of goods to the information monitoring system of information in accordance with paragraph 78 of these Rules;<\/p>\n

                            “disposed of” \u2014 the identification code as part of the labeling code has been disposed of from circulation, the corresponding goods have been withdrawn from circulation;<\/p>\n

                              \n
                            1. b) for the identification code of transport packaging, aggregated customs code:<\/li>\n<\/ol>\n

                              “formed” \u2014 is assigned automatically after the submission of information by a participant in the circulation of goods with a described composition of the identification code of transport packaging, aggregated customs code;<\/p>\n

                              “disbanded” \u2014 is assigned automatically in the process of complete disbandment of the composition of transport packaging, aggregated customs code.<\/p>\n

                                \n
                              1. Labeling of goods by means of identification is carried out taking into account the safety requirements for goods.<\/li>\n<\/ol>\n

                                 <\/p>\n

                                  \n
                                1. Requirements for Participants in the Circulation of Goods, the Procedure for Their Registration in the Information Monitoring System. Requirements for Service Providers<\/strong><\/li>\n
                                2. Participants in the circulation of goods shall: (as amended by Resolution of the Government of the Russian Federation of May 31, 2024 No. 743)<\/li>\n
                                3. a) possess a qualified certificate of the electronic signature verification key corresponding to the electronic signature key enabling the creation of a qualified enhanced electronic signature (hereinafter \u2014 enhanced electronic signature); (as amended by Resolution of the Government of the Russian Federation of May 31, 2024 No. 743)<\/li>\n
                                4. b) have a hardware and software complex capable of generating and signing electronic documents with an enhanced electronic signature, as well as exchanging the necessary electronic documents with the information monitoring system, including through a personal account; (as amended by Resolution of the Government of the Russian Federation of May 31, 2024 No. 743)<\/li>\n
                                5. c) have remote access to the emission registration device located in the infrastructure of the information monitoring system (for participants in the circulation of goods carrying out the labeling and\/or relabeling of goods in accordance with the requirements of these Rules); (as amended by Resolution of the Government of the Russian Federation of May 31, 2024 No. 743)<\/li>\n
                                6. d) have a contract concluded with an electronic document flow operator (for participants in the circulation of goods carrying out the transmission of the information provided for by these Rules in the procedure provided for by paragraph 23 of these Rules). (as amended by Resolution of the Government of the Russian Federation of May 31, 2024 No. 743)<\/li>\n
                                7. A participant in the circulation of goods carrying out trade using cash register equipment (including commission trade in the cases provided for by the Federal Law “On the Fundamentals of State Regulation of Trade Activities in the Russian Federation”), in addition to the requirements provided for by paragraph 7 of these Rules, shall have:<\/li>\n
                                8. a) software and\/or hardware means for recognition of means of identification integrated with the cash register equipment;<\/li>\n
                                9. b) a contract concluded with an organization established in accordance with the legislation of the Russian Federation, located on the territory of the Russian Federation, having received in accordance with the legislation of the Russian Federation on the use of cash register equipment a permit for the processing of fiscal data (hereinafter \u2014 the fiscal data operator), for the processing and transmission on behalf of the participant in the circulation of goods to the information monitoring system of information on the circulation of goods in the event that the operation is carried out between participants in the circulation of goods registered in the information monitoring system, or on the withdrawal from circulation of labeled goods using cash register equipment for each sold unit of goods (with the exception of the transmission of information on the withdrawal from circulation of labeled goods in cases of the use of cash register equipment in a mode that does not provide for the mandatory transmission of fiscal documents to the tax authorities in electronic form through the fiscal data operator).<\/li>\n
                                10. The provision of remote access to the emission registration device located in the infrastructure of the information monitoring system is carried out by the operator of the information monitoring system on a gratuitous basis.<\/li>\n
                                11. Service providers shall have a complex of printing equipment with a capacity sufficient for the conversion and application of means of identification on behalf of a participant in the circulation of goods, but not less than the regularly placed orders for the production of consumer packaging and labels from the participant in the circulation of goods, and ensuring the printing of labeling code symbols of not lower than class 2.5 (B) in accordance with the requirements of the national standard of the Russian Federation GOST R ISO\/IEC 15415-2012 “Information technologies. Automatic identification and data capture technologies. Bar code symbol print quality test specification. Two-dimensional symbols”, approved by the order of the Federal Agency for Technical Regulation and Metrology of September 18, 2012 No. 357-st and put into effect on July 1, 2013 (hereinafter \u2014 the national standard of the Russian Federation GOST R ISO\/IEC 15415-2012).<\/li>\n
                                12. Service providers ensure compliance with the following rules for the handling of labeling codes, such as:<\/li>\n
                                13. a) storage of labeling codes received from participants in the circulation of goods using the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system;<\/li>\n
                                14. b) use of the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system for the delivery of labeling codes from the participant in the circulation of goods to the service provider;<\/li>\n
                                15. c) delivery of information on the application and\/or validation of the means of identification to the participant in the circulation of goods using the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system;<\/li>\n
                                16. d) use of the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system \u2014 in the event of the need to transfer labeling codes received from the participant in the circulation of goods to another service provider;<\/li>\n
                                17. e) hardware-based (using machine vision means) validation of the means of identification;<\/li>\n
                                18. f) deletion of the verification code after validation of the means of identification and generation of information on the application and validation of the means of identification;<\/li>\n
                                19. g) selection of labeling codes from the repository of the hardware and software complex for the distribution of labeling codes with separate operational storage (in the process of the production cycle of conversion of labeling codes into means of identification) of labeling codes and information on the application and validation of the means of identification of various participants in the circulation of goods;<\/li>\n
                                20. h) ensuring the impossibility of repeated application of labeling codes after their conversion and validation of the means of identification;<\/li>\n
                                21. i) transmission to the participant in the circulation of goods of information on the validation of means of identification.<\/li>\n
                                22. The service provider ensures:<\/li>\n
                                23. a) conversion of labeling codes into means of identification (print management);<\/li>\n
                                24. b) generation of information on the application and\/or validation of the means of identification and its submission to the participant in the circulation of goods;<\/li>\n
                                25. c) compliance with the printing quality standards for means of identification and validation of the means of identification prior to the transfer of consumer packaging, or group packaging, or a set, or a label with the applied means of identification to the participant in the circulation of goods.<\/li>\n
                                26. The provision to the service provider of the hardware and software complex for the distribution of labeling codes is carried out by the operator of the information monitoring system on a gratuitous basis.<\/li>\n
                                27. For the purpose of receiving the said hardware and software complex for the distribution of labeling codes, service providers shall conclude contracts with the operator of the information monitoring system.<\/li>\n
                                28. Registration of a participant in the circulation of goods in the information monitoring system is carried out on the basis of an application of the participant in the circulation of goods submitted to the information monitoring system and signed with the enhanced electronic signature of the participant in the circulation of goods. (as amended by Resolution of the Government of the Russian Federation of May 31, 2024 No. 743)<\/li>\n
                                29. In addition to the information provided for by paragraph 14 of the Rules for Labeling of Goods, the application for registration in the information monitoring system shall contain:<\/li>\n
                                30. a) the surname, first name, patronymic (if any) of the person having the right to act on behalf of the participant in the circulation of goods without a power of attorney;<\/li>\n
                                31. b) the telephone number and email address of the participant in the circulation of goods to which notifications from the information monitoring system will be sent.<\/li>\n
                                32. To an applicant \u2014 a branch of a foreign legal entity, in addition to the grounds provided for by paragraph 17 of the Rules for Labeling of Goods (excluding the ground provided for by subparagraph “d” of the said paragraph), registration in the information monitoring system shall be refused in the event of a discrepancy between the information in respect of the applicant specified in the application for registration and the information specified in the state register of accredited branches and representative offices of foreign legal entities, as well as in the event of the absence in the said register of a record of the applicant or the presence of a record of the termination of its accreditation.<\/li>\n
                                33. Upon the application of the person having the right to act on behalf of the participant in the circulation of goods without a power of attorney, information on persons authorized to sign certain documents on behalf of the participant in the circulation of goods (hereinafter \u2014 the authorized person) may be entered into the information monitoring system. Such application shall contain the following information:<\/li>\n
                                34. a) the electronic signature verification key certificate of the enhanced electronic signature of the authorized person;<\/li>\n
                                35. b) the surname, first name, patronymic (if any) of the authorized person;<\/li>\n
                                36. c) the types of documents submitted to the information monitoring system, the right to sign which has been granted to the authorized person;<\/li>\n
                                37. d) the availability of a document confirming the authority of the authorized person;<\/li>\n
                                38. e) the period of validity of the document confirming the authority of the authorized person.<\/li>\n
                                39. In the event of the termination of the authority of the authorized person, the person having the right to act on behalf of the participant in the circulation of goods without a power of attorney shall enter into the information monitoring system information on the date of termination of the document confirming the authority of the authorized person.<\/li>\n
                                40. In the entry into the information monitoring system of information on the authorized person, in addition to the grounds for refusal provided for by paragraph 29 of these Rules, refusal shall also be made in the event that the authorized person is already registered in the information monitoring system as an authorized person of the given participant in the circulation of goods.<\/li>\n
                                41. A participant in the circulation of goods previously registered in the information monitoring system as a participant in the circulation of other goods subject to mandatory labeling by means of identification, for registration as a participant in the circulation of goods, shall submit to the information monitoring system a corresponding notification containing the following information:<\/li>\n
                                42. a) the taxpayer identification number of the participant in the circulation of goods;<\/li>\n
                                43. b) the name of the product group “Medical devices”;<\/li>\n
                                44. c) the type of participant in the circulation of goods (one participant in the circulation of goods may belong to several types).<\/li>\n<\/ol>\n

                                   <\/p>\n

                                  III. Procedure for Information Exchange between Participants in the Circulation of Goods and the Information Monitoring System<\/strong><\/p>\n

                                    \n
                                  1. The submission of information by participants in the circulation of goods to the Information Monitoring System shall be carried out using standard data transmission protocols and electronic interaction interfaces developed by the operator of the Information Monitoring System, through the exchange of electronic documents (application, notification, receipt, etc.), the format of which is determined by the operator of the Information Monitoring System and posted on the official website of the operator of the Information Monitoring System on the Internet.<\/li>\n
                                  2. The obligation to submit to the Information Monitoring System the information provided for by these Rules, transmitted as part of universal transfer documents, corrected universal transfer documents, and universal adjustment documents, shall be fulfilled by the participant in the circulation of goods through an electronic document flow operator on the basis of an agreement concluded between them, which must provide for the following:<\/li>\n
                                  3. a) the transfer of universal transfer documents, corrected universal transfer documents, and universal adjustment documents signed by both parties to the transaction by the participant in the circulation of goods via the electronic document flow operator to the Information Monitoring System shall be carried out in real time;<\/li>\n
                                  4. b) the transfer by the electronic document flow operator to the participant in the circulation of goods of notifications (receipts) from the Information Monitoring System operator specified in paragraph\u00a030 of these Rules shall be carried out in real time;<\/li>\n
                                  5. c) the date of fulfillment of the participant\u2019s obligation to submit information to the Information Monitoring System shall be deemed the date when the universal transfer document, corrected universal transfer document, or universal adjustment document is received by the operator of the Information Monitoring System;<\/li>\n
                                  6. d) the participant in the circulation of goods shall be responsible for the accuracy of the information contained in the universal transfer documents, corrected universal transfer documents, and universal adjustment documents; the electronic document flow operator shall be responsible for the integrity and timeliness of the transfer to the Information Monitoring System of the universal transfer documents, corrected universal transfer documents, and universal adjustment documents submitted by the participant in the circulation of goods.<\/li>\n
                                  7. The submission by a participant in the circulation of goods of information on a group package or a set shall be equated to the submission of information on consumer packages contained in that group package or set, respectively, based on the data of the Information Monitoring System. The participant in the circulation of goods shall independently aggregate labeled goods in consumer packages into a group package and\/or a set and submit to the Information Monitoring System information on the identification codes included in the identification code of the group package and\/or the identification code of the set, respectively. Aggregation of labeled goods in consumer packages into a group package and\/or a set is not allowed if they are already included in another group package and\/or set.<\/li>\n
                                  8. The submission by a participant in the circulation of goods of information on transport packaging shall be equated to the submission of information on all (consumer, group, transport) packages or sets contained in that transport packaging, based on the data of the Information Monitoring System. The participant in the circulation of goods shall independently aggregate labeled goods in consumer packages, and\/or group packages, and\/or transport packages, and\/or sets into transport packaging and submit to the Information Monitoring System information on the identification codes, and\/or identification codes of group packages, and\/or identification codes of sets, and\/or identification codes of transport packages included in the identification code of the transport package. Aggregation of labeled goods in consumer packages, and\/or group packages, and\/or transport packages, and\/or sets into transport packaging is not allowed if they are already included in another transport package.<\/li>\n
                                  9. The submission by a participant in the circulation of goods of information on the inclusion of consumer packages in a group package or a set, or on the inclusion in transport packaging of consumer packages, or group packages, or transport packages, or sets which, according to the Information Monitoring System data, were previously included in another group package, or set, or transport package, shall be the basis for recording in the Information Monitoring System the fact of disbanding the previously created group packages, or sets, and\/or transport packages that included those packages.<\/li>\n
                                  10. The submission by a participant in the circulation of goods of information on aggregated customs codes shall be equated to the submission of information on identification codes, identification codes of sets, identification codes of group packages of goods imported (brought) into the customs territory of the Eurasian Economic Union contained in the aggregated customs code, based on the data of the Information Monitoring System..<\/li>\n
                                  11. Starting from October\u00a01, 2023, participants in the circulation of goods shall submit to the Information Monitoring System information on identification codes, and\/or identification codes of group packages, and\/or identification codes of sets, and\/or identification codes of transport packages when putting into circulation air disinfectants\u2011purifiers (including equipment, bactericidal units, and recirculators used for filtering and purifying air in rooms), orthopedic footwear, and orthopedic shoe correction inserts (including insoles, half\u2011insoles).<\/li>\n<\/ol>\n

                                    Starting from March\u00a01, 2024, participants in the circulation of goods shall submit to the Information Monitoring System information on identification codes, and\/or identification codes of group packages, and\/or identification codes of sets, and\/or identification codes of transport packages when putting into circulation hearing aids (except for parts and accessories), coronary stents, computed tomography scanners, and sanitary\u2011hygienic products used for incontinence.<\/p>\n

                                    At the same time, information within transactions involving the transfer of ownership of these goods (except for sanitary\u2011hygienic products used for incontinence), as well as within commission agreements, and\/or agency agreements, and\/or contract agreements, and\/or mandate agreements, shall not be transmitted to the Information Monitoring System until August\u00a031, 2025 (inclusive). For sanitary\u2011hygienic products used for incontinence, information within transactions involving the transfer of ownership of these goods, as well as within commission agreements, and\/or agency agreements, and\/or contract agreements, and\/or mandate agreements, shall not be transmitted to the Information Monitoring System until February\u00a028, 2026 (inclusive). (as amended by Resolution of the Government of the Russian Federation of September\u00a012, 2025 No.\u00a01409)<\/p>\n

                                    Starting from September\u00a01, 2024, in addition to the information provided in the first and second paragraphs of this clause, participants in the circulation of goods shall submit to the Information Monitoring System information on identification codes, and\/or identification codes of group packages, and\/or identification codes of sets when withdrawing them from circulation.<\/p>\n

                                    Starting from March\u00a01, 2025, participants in the circulation of goods shall submit to the Information Monitoring System information on identification codes, and\/or identification codes of group packages, and\/or identification codes of sets, and\/or identification codes of transport packages when putting medical gloves into circulation and when withdrawing them from circulation. For medical gloves, information within transactions involving the transfer of ownership of these goods, as well as within commission agreements, and\/or agency agreements, and\/or contract agreements, and\/or mandate agreements, shall not be transmitted to the Information Monitoring System until February\u00a028, 2026 (inclusive). (as amended by Resolutions of the Government of the Russian Federation of June\u00a026, 2024 No.\u00a0860, of September\u00a012, 2025 No.\u00a01409)<\/p>\n

                                    Starting from September\u00a01, 2025, participants in the circulation of goods shall submit to the Information Monitoring System information on identification codes, and\/or identification codes of group packages, and\/or identification codes of sets, and\/or identification codes of transport packages for goods put into circulation from September\u00a01, 2025, both when putting goods into circulation and withdrawing goods from circulation, as well as within transactions involving the transfer of ownership of these goods, and within commission agreements, and\/or agency agreements, and\/or contract agreements, and\/or mandate agreements. (as amended by Resolution of the Government of the Russian Federation of September\u00a012, 2025 No.\u00a01409)<\/p>\n

                                    Paragraph\u00a07 of clause\u00a028 of the Rules applies to legal relations arising from September\u00a01, 2025 (clause\u00a02 of Resolution of the Government of the Russian Federation of September\u00a012, 2025 No.\u00a01409).<\/p>\n

                                    Starting from March\u00a01, 2026, participants in the circulation of goods, with respect to sanitary\u2011hygienic products used for incontinence and medical gloves put into circulation from March\u00a01, 2026, shall submit to the Information Monitoring System information on identification codes, and\/or identification codes of group packages, and\/or identification codes of sets, and\/or identification codes of transport packages both when putting the goods into circulation and withdrawing the goods from circulation, as well as within transactions involving the transfer of ownership of such goods, and within commission agreements, and\/or agency agreements, and\/or contract agreements, and\/or mandate agreements. (as amended by Resolution of the Government of the Russian Federation of September\u00a012, 2025 No.\u00a01409)<\/p>\n

                                      \n
                                    1. The operator of the Information Monitoring System shall refuse to accept documents (applications, notifications) or to enter information submitted by participants in the circulation of goods into the Information Monitoring System if any of the following grounds exist:<\/li>\n
                                    2. a) the submitted documents are prepared in violation of the established format, contain incorrect information, or do not contain mandatory information provided for in Sections\u00a0II, VIII, and IX of these Rules;<\/li>\n
                                    3. b) the document is not signed or is signed by a person not authorized by the participant in the circulation of goods to sign the document on behalf of the participant or not entitled to sign this type of document;<\/li>\n
                                    4. c) there is an entry in the Unified State Register of Legal Entities regarding the termination of the legal entity\u2019s activities, or an entry in the Unified State Register of Individual Entrepreneurs regarding the termination of the individual entrepreneur\u2019s activities, or an entry in the State Register of Accredited Branches and Representative Offices of Foreign Legal Entities regarding the termination of accreditation of a branch of a foreign legal entity with respect to the participant in the circulation of goods;<\/li>\n
                                    5. d) the information specified in clause\u00a083 of these Rules, requested in the Unified Automated Information System of Customs Authorities or by customs authorities through another method provided for in the information exchange agreement, has not been received by the Information Monitoring System.<\/li>\n
                                    6. The participant in the circulation of goods shall be notified of the receipt of submitted electronic documents, or of the entry of information into the Information Monitoring System, or of the refusal to accept electronic documents, or of the refusal to enter information into the Information Monitoring System by sending a notification (receipt) regarding the receipt of electronic documents, or the entry of information into the Information Monitoring System, or the refusal to accept electronic documents, or the refusal to enter information into the Information Monitoring System, containing the following information:<\/li>\n
                                    7. a) the registration number of the document received from the participant in the circulation of goods;<\/li>\n
                                    8. b) the notification (receipt) number;<\/li>\n
                                    9. c) the date of the notification (receipt);<\/li>\n
                                    10. d) identification codes, identification codes of group packages, identification codes of sets, identification codes of transport packages, aggregated customs codes (in the case of goods manufactured outside the territory of the Russian Federation and imported (brought) into the customs territory of the Eurasian Economic Union) and their status (status change) in the Information Monitoring System (if the document submitted by the participant in the circulation of goods contains information on operations performed with the goods);<\/li>\n
                                    11. e) a message regarding the receipt or entry of documents (information) into the Information Monitoring System or the reasons for the refusal to enter them.<\/li>\n<\/ol>\n

                                      30.1. Electronic documents automatically generated and submitted by participants in the circulation of goods to the Information Monitoring System in accordance with clause\u00a022 of these Rules (except for the application for registration of a participant in the circulation of goods, the request for testing information interaction, and the request for access to the emission registration device) may be signed with an enhanced electronic signature of that participant in the circulation of goods who performs the functions of the operator of the relevant information system, using electronic signature tools used for the automatic creation of electronic signatures. (as amended by Resolution of the Government of the Russian Federation of May\u00a031, 2024 No.\u00a0743)<\/p>\n

                                        \n
                                      1. Notifications (receipts) specified in clause\u00a030 of these Rules shall be sent by the operator of the Information Monitoring System to the electronic document flow operator, or to the fiscal data operator, or to the participant in the circulation of goods using electronic interaction interfaces via the personal account in the Information Monitoring System or by email within one calendar day from the date the participant in the circulation of goods submits documents or information to the Information Monitoring System.<\/li>\n
                                      2. The fact that the participant in the circulation of goods has fulfilled the obligation to submit electronic documents (information) to the Information Monitoring System shall be confirmed by a notification (receipt) of the entry of electronic documents (information) into the Information Monitoring System.<\/li>\n<\/ol>\n

                                        The date of submission by the participant in the circulation of goods of electronic documents (information) to the Information Monitoring System shall be recognized as the date recorded in the notification (receipt) of the acceptance of electronic documents (receipt of information).<\/p>\n

                                        The said notifications (receipts) shall be automatically generated, signed with an enhanced electronic signature of the operator of the Information Monitoring System using electronic signature tools used for the automatic creation of electronic signatures, and sent to the participant in the circulation of goods via the Information Monitoring System in the form of an electronic document when the submitted documents (information) are placed in the Information Monitoring System.<\/p>\n

                                          \n
                                        1. The obligation to submit to the Information Monitoring System the information provided for by these Rules upon the supply of labeled goods under contracts concluded in accordance with the Federal Law on the Contract System may be fulfilled by participants in the circulation of goods by submitting acceptance documents provided for in Part\u00a013 of Article\u00a094 of the Federal Law on the Contract System (hereinafter \u2014 acceptance documents) to the Unified Information System in the Procurement Sphere (hereinafter \u2014 Procurement Information System).<\/li>\n<\/ol>\n

                                          Information interaction between the Information Monitoring System and the Procurement Information System shall be carried out in accordance with the information exchange agreement. Notifications (receipts) of the Information Monitoring System operator specified in clause\u00a030 of these Rules, in the case of data transmission under this clause, shall be transmitted by the Information Monitoring System operator to the participants in the circulation of goods and to the federal executive body performing the functions of creating, developing, maintaining, and servicing the Procurement Information System (hereinafter \u2014 the Procurement Information System operator).<\/p>\n

                                          The Procurement Information System operator shall ensure:<\/p>\n

                                          the transfer of acceptance documents signed by both parties to the contract to the Information Monitoring System within 2\u00a0hours from the moment the recipient of the goods signs the acceptance document in the Procurement Information System and it is posted in the Procurement Information System, as well as informing the participant in the circulation of goods about the results of the transfer;<\/p>\n

                                          the transfer to participants in the circulation of goods of notifications (receipts) of the Information Monitoring System operator specified in clause\u00a030 of these Rules within 2\u00a0hours from the moment the recipient of the goods signs the acceptance document in the Procurement Information System and it is posted in the Procurement Information System, provided that such notifications (receipts) are received from the Information Monitoring System operator.<\/p>\n

                                          In the case of transferring an acceptance document via the Procurement Information System operator:<\/p>\n

                                          the date of fulfillment of the participant\u2019s obligation to submit information to the Information Monitoring System shall be the date when the acceptance document is received by the operator of the Information Monitoring System;<\/p>\n

                                          the participant in the circulation of goods shall be responsible for the accuracy of the information contained in the acceptance documents and corrected acceptance documents; the Procurement Information System operator shall be responsible for the integrity and timeliness of the transfer to the Information Monitoring System of the acceptance documents and corrected acceptance documents submitted by the participant in the circulation of goods.<\/p>\n

                                            \n
                                          1. The obligation to submit to the Information Monitoring System the information provided for by these Rules in the case of centralized supply and withdrawal from circulation of labeled goods under contracts concluded in accordance with the Federal Law on the Contract System shall be fulfilled by the participant in the circulation of goods engaged in healthcare and social\u2011medical services, who is the actual consignee of such goods, in accordance with the procedure provided for in clause\u00a023 of these Rules.<\/li>\n
                                          2. Participants in the circulation of goods shall submit information to the Information Monitoring System both independently and with the involvement of other legal entities or individual entrepreneurs authorized by the participants in the circulation of goods and acting on their behalf in accordance with the legislation of the Russian Federation.<\/li>\n<\/ol>\n

                                            The operator of the Information Monitoring System shall ensure the placement of documents and information submitted by the participant in the circulation of goods in the Information Monitoring System within one calendar day from the date of receipt of such documents and information, with mandatory sending of a notification (receipt) of amendments entered into the Information Monitoring System to the applicant, as well as to other participants in the circulation of goods who received goods from the applicant or transferred goods to the applicant if such amendments affect their interests.<\/p>\n

                                             <\/p>\n

                                              \n
                                            1. Registration of Goods in the Information Monitoring System<\/strong><\/li>\n
                                            2. Registration of goods shall be carried out by participants in the circulation of goods in the subsystem of the National Catalog of Labeled Goods on the basis of an application for goods registration:<\/li>\n
                                            3. a) in the case of production of goods on the territory of the Russian Federation \u2014 by manufacturers (including in cases of contract manufacturing);<\/li>\n
                                            4. b) in the case of production of goods outside the territory of the Russian Federation, including goods imported from member states of the Eurasian Economic Union within cross\u2011border trade on the customs territory of the Eurasian Economic Union \u2014 by the importer;<\/li>\n
                                            5. c) in the case of sale of goods previously acquired under a transaction the details of which constitute state secrets \u2014 by the participant in the circulation of goods who acquired the goods and decided to further sell (sell) them under a transaction the details of which do not constitute state secrets;<\/li>\n
                                            6. d) in the case of return of goods by the consumer in accordance with the legislation of the Russian Federation on consumer protection on the territory of the Russian Federation \u2014 by the participant in the circulation of goods being a retail trade organization;<\/li>\n
                                            7. e) in the case of returning goods to circulation acquired by participants in the circulation of goods for purposes not related to their subsequent sale (sale) \u2014 by the participant in the circulation of goods returning the goods to circulation;<\/li>\n
                                            8. f) in the case of acquisition for the purpose of further sale (sale) of goods as a result of auctions within enforcement proceedings and bankruptcy procedures, auctions of property confiscated in administrative and criminal proceedings, as well as as a result of the sale of property transferred to the ownership of the Russian Federation in accordance with the legislation of the Russian Federation \u2014 by the participant in the circulation of goods who acquired these goods;<\/li>\n
                                            9. g) in the case of goods not labeled with means of identification that are in circulation as of the date of the commencement of mandatory labeling of goods (residual goods) \u2014 by the participant in the circulation of goods carrying out the circulation of such goods;<\/li>\n
                                            10. h) in the case of the formation of sets \u2014 by the participant in the circulation of goods prior to the sale (sale) of such sets to third parties, including prior to their display at the place of sale (sale), demonstration of their samples.<\/li>\n
                                            11. For the registration of air disinfectants \u2014 air purifiers (including equipment, bactericidal units and recirculators used for filtering and air purification in premises), hearing aids, and computed tomography scanners in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information about the goods being registered:<\/li>\n
                                            12. a) the taxpayer identification number of the applicant;<\/li>\n
                                            13. b) the product code (if available);<\/li>\n
                                            14. c) the full name of the goods;<\/li>\n
                                            15. d) the trademark (if available);<\/li>\n
                                            16. e) the 10-digit code of the commodity nomenclature;<\/li>\n
                                            17. f) the country of manufacture code in accordance with the All-Russian Classifier of Countries of the World;<\/li>\n
                                            18. g) the type of goods;<\/li>\n
                                            19. h) the model (article) of the manufacturer;<\/li>\n
                                            20. i) the registration certificate number for the medical device and the name of the medical device model;<\/li>\n
                                            21. j) the number and date of the declaration of conformity (if available);<\/li>\n
                                            22. k) the shelf life or service life, the number of months (for the service life).<\/li>\n
                                            23. For the registration of orthopedic footwear in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information about the goods being registered:<\/li>\n
                                            24. a) the taxpayer identification number of the applicant;<\/li>\n
                                            25. b) the product code (if available);<\/li>\n
                                            26. c) the full name of the goods;<\/li>\n
                                            27. d) the trademark (if available);<\/li>\n
                                            28. e) the 10-digit code of the commodity nomenclature;<\/li>\n
                                            29. f) the country of manufacture code in accordance with the All-Russian Classifier of Countries of the World;<\/li>\n
                                            30. g) the category of goods;<\/li>\n
                                            31. h) the type of footwear;<\/li>\n
                                            32. i) the size in the Paris point system (stitchmass system);<\/li>\n
                                            33. j) the color;<\/li>\n
                                            34. k) the material of the upper;<\/li>\n
                                            35. l) the material of the lining;<\/li>\n
                                            36. m) the material of the bottom (sole);<\/li>\n
                                            37. n) the model (article) of the manufacturer;<\/li>\n
                                            38. o) the functional purpose;<\/li>\n
                                            39. p) the medical purpose according to the degree of severity of the static-dynamic function impairment;<\/li>\n
                                            40. q) the registration certificate number for the medical device and the name of the medical device model;<\/li>\n
                                            41. r) the number and date of the declaration of conformity (if available);<\/li>\n
                                            42. s) the shelf life or service life, the number of months (for the service life).<\/li>\n
                                            43. For the registration of orthopedic shoe correction inserts (including insoles, half-insoles) in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information about the goods being registered:<\/li>\n
                                            44. a) the taxpayer identification number of the applicant;<\/li>\n
                                            45. b) the product code (if available);<\/li>\n
                                            46. c) the full name of the goods;<\/li>\n
                                            47. d) the trademark (if available);<\/li>\n
                                            48. e) the 10-digit code of the commodity nomenclature;<\/li>\n
                                            49. f) the country of manufacture code in accordance with the All-Russian Classifier of Countries of the World;<\/li>\n
                                            50. g) the category of goods;<\/li>\n
                                            51. h) the type of goods;<\/li>\n
                                            52. i) the functional purpose;<\/li>\n
                                            53. j) the method of use;<\/li>\n
                                            54. k) the composition;<\/li>\n
                                            55. l) the registration certificate number for the medical device and the name of the medical device model;<\/li>\n
                                            56. m) the number and date of the declaration of conformity (if available);<\/li>\n
                                            57. n) the shelf life or service life, the number of months (for the service life).<\/li>\n
                                            58. For the registration of coronary stents in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information about the goods being registered:<\/li>\n
                                            59. a) the taxpayer identification number of the applicant;<\/li>\n
                                            60. b) the product code (if available);<\/li>\n
                                            61. c) the full name of the goods;<\/li>\n
                                            62. d) the trademark (if available);<\/li>\n
                                            63. e) the 10-digit code of the commodity nomenclature;<\/li>\n
                                            64. f) the country of manufacture code in accordance with the All-Russian Classifier of Countries of the World;<\/li>\n
                                            65. g) the type of goods;<\/li>\n
                                            66. h) the model (article) of the manufacturer;<\/li>\n
                                            67. i) the stent length;<\/li>\n
                                            68. j) the free outer diameter of the stent;<\/li>\n
                                            69. k) the stent design type;<\/li>\n
                                            70. l) the material of the stent frame;<\/li>\n
                                            71. m) the registration certificate number for the medical device and the name of the medical device model;<\/li>\n
                                            72. n) the number and date of the declaration of conformity (if available);<\/li>\n
                                            73. o) the shelf life or service life, the number of months (for the service life).<\/li>\n
                                            74. For the registration of sanitary-hygienic products used for incontinence in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information about the goods being registered:<\/li>\n
                                            75. a) the taxpayer identification number of the applicant;<\/li>\n
                                            76. b) the product code (if available);<\/li>\n
                                            77. c) the full name of the goods;<\/li>\n
                                            78. d) the trademark (if available);<\/li>\n
                                            79. e) the 10-digit code of the commodity nomenclature;<\/li>\n
                                            80. f) the country of manufacture code in accordance with the All-Russian Classifier of Countries of the World;<\/li>\n
                                            81. g) the category of goods;<\/li>\n
                                            82. h) the type of goods;<\/li>\n
                                            83. i) the number of units of use in the consumer package;<\/li>\n
                                            84. j) the absorption capacity (moisture absorption);<\/li>\n
                                            85. k) the composition;<\/li>\n
                                            86. l) the waist (hip) circumference (in respect of adult diapers);<\/li>\n
                                            87. m) the size of the product (in respect of diapers and absorbent products for adults);<\/li>\n
                                            88. n) the target gender (in respect of urological pads and inserts);<\/li>\n
                                            89. o) the registration certificate number for the medical device and the name of the medical device model;<\/li>\n
                                            90. p) the number and date of the state registration certificate and\/or declaration of conformity (if available);<\/li>\n
                                            91. q) the shelf life or service life, the number of months (for the service life).<\/li>\n<\/ol>\n

                                              41(1). For the registration of medical gloves in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information about the goods being registered: (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/p>\n

                                                \n
                                              1. a) the taxpayer identification number of the applicant; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              2. b) the product code (if available); (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              3. c) the full name of the goods; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              4. d) the trademark (if available); (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              5. e) the 10-digit code of the commodity nomenclature; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              6. f) the country of manufacture code in accordance with the All-Russian Classifier of Countries of the World; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              7. g) the category of goods; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              8. h) the type of goods; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              9. i) the number of units of use in the consumer package; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              10. j) the size of the product; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              11. k) the composition; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              12. l) the registration certificate number for the medical device and the name of the medical device model; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              13. m) the number and date of the declaration of conformity (if available); (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              14. n) the shelf life or service life, the number of months (for the service life). (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              15. For the registration of a set in the subsystem of the national catalog of labeled goods, the participant in the circulation of goods shall submit the following information:<\/li>\n
                                              16. a) the taxpayer identification number of the applicant;<\/li>\n
                                              17. b) the product code for the set (if available);<\/li>\n
                                              18. c) the full name of the set;<\/li>\n
                                              19. d) the trademark (if available);<\/li>\n
                                              20. e) the 10-digit code of the commodity nomenclature (if available);<\/li>\n
                                              21. f) the product codes of the labeled goods included in the set;<\/li>\n
                                              22. g) the number of units of goods for each product code of the labeled goods included in the set;<\/li>\n
                                              23. h) the composition of the set (optional).<\/li>\n
                                              24. In addition to the information specified in paragraphs 37 \u2014 41.1 of these Rules, the participant in the circulation of goods, when registering goods, shall have the right to submit photographs of the goods from various angles. (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/li>\n
                                              25. In the event of a positive result of the review of the application for the registration of goods, the operator of the information monitoring system shall, no later than 3 working days from the date of receipt of such application, carry out the registration of goods in the subsystem of the national catalog of labeled goods and send the applicant a notification of the registration of goods in the subsystem of the national catalog of labeled goods.<\/li>\n<\/ol>\n

                                                In addition to the grounds provided for by paragraph 29 of these Rules, the ground for refusal to accept documents or to enter information into the subsystem of the national catalog of labeled goods submitted by participants in the circulation of goods to the subsystem of the national catalog of labeled goods is the existence of one of the following grounds:<\/p>\n

                                                the information provided for by paragraphs 37, and\/or 38, and\/or 39, and\/or 40, and\/or 41, and\/or 41(1), and\/or 42 of these Rules has not been submitted; (as amended by Resolution of the Government of the Russian Federation of June 26, 2024 No. 860)<\/p>\n

                                                the submitted information is not contained in or does not correspond to the information in the state register of medical devices and organizations (individual entrepreneurs) carrying out the production and manufacture of medical devices.<\/p>\n

                                                 <\/p>\n

                                                  \n
                                                1. Characteristics of the Means of Identification, Including the Structure and Format of Labeling Codes, Identification Codes and Verification Codes<\/strong><\/li>\n
                                                2. The means of identification shall be applied in the form of a two-dimensional bar code in Data Matrix format in accordance with the requirements of the national standard of the Russian Federation GOST R ISO\/IEC 16022-2008 “Automatic identification. Bar coding. Data Matrix symbology specification”, approved by the order of the Federal Agency for Technical Regulation and Metrology of December 18, 2008 No. 509-st and put into effect on January 1, 2010 (hereinafter \u2014 the national standard of the Russian Federation GOST R ISO\/IEC 16022-2008), using ECC 200 symbology and using FNC1 as a symbology indicator (having code 232 in the ASCII character table) and data conformity to the standard format of application identifiers (AI) of GS1 in accordance with paragraph 5.2.4.6 of the national standard of the Russian Federation GOST R ISO\/IEC 16022-2008.<\/li>\n
                                                3. The following requirements shall apply to the conversion and quality of application of means of identification:<\/li>\n
                                                4. a) the conversion of a labeling code into a means of identification shall be carried out using the ECC 200 error correction method and the ASCII character set in accordance with the requirements of the national standard of the Russian Federation GOST R ISO\/IEC 16022-2008;<\/li>\n
                                                5. b) the print quality of the means of identification shall comply with the requirements of the national standard of the Russian Federation GOST R ISO\/IEC 15415-2012, and, when applied by a participant in the circulation of goods, shall be not lower than class 1.5 (C) in accordance with such national standard;<\/li>\n
                                                6. c) the recommended range of sizes of Data Matrix elements constituting the two-dimensional bar code is from 0.255 to 0.680 millimeters. The size of the means of identification shall comply with the requirements of the national standard of the Russian Federation GOST R ISO\/IEC 16022-2008.<\/li>\n
                                                7. When converting labeling codes into means of identification and labeling goods, service providers and participants in the circulation of goods shall ensure compliance with the print quality standards of the means of identification specified in paragraphs 10 and 46 of these Rules.<\/li>\n
                                                8. When a participant in the circulation of goods engages a service provider, the participant in the circulation of goods shall transfer the labeling codes to the service provider for conversion and application by means of the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system to the service provider. After the conversion of the labeling code into a means of identification and the labeling of the goods by the service provider, validation of the means of identification shall be carried out prior to the transfer to the participant in the circulation of goods of the consumer package, or group package, or set, or label with the applied means of identification. Information on the application and validation of means of identification shall be submitted by service providers to the participant in the circulation of goods by means of the hardware and software complex for the distribution of labeling codes.<\/li>\n
                                                9. The printing equipment on which the conversion of the means of identification is carried out shall ensure the necessary printing resolution, where the Data Matrix code element shall be from 0.255 to 0.680 millimeters, with the physical size of the Data Matrix code being determined by the amount of encoded data and the size of a single element, shall comply with the requirements of the national standard of the Russian Federation GOST R ISO\/IEC 16022-2008 and shall ensure the print quality of the applied labeling code symbols not lower than class 1.5 (C) at the final stage of the technological process of validation of the applied means of identification immediately prior to the shipment of the manufactured consumer package, or group package, or manufactured set, or label with the means of identification applied to it to the participant in the circulation of goods carrying out the packaging of goods.<\/li>\n
                                                10. The service provider shall use certified materials satisfying the sanitary-hygienic requirements of the technical regulation of the Customs Union “On the Safety of Packaging” (TR CU 005\/2011), approved by the Resolution of the Commission of the Customs Union of August 16, 2011 No. 769.<\/li>\n
                                                11. The method of application of the means of identification shall ensure the preservation (durability) of the means of identification throughout the entire shelf life or service life of the goods, provided that the storage and transportation conditions established by the manufacturer are observed.<\/li>\n
                                                12. A service provider shall have the right to transfer labeling codes received from a participant in the circulation of goods only to another service provider. The transfer of labeling codes shall be carried out for the purpose of fulfilling its obligations to such participant in the circulation of goods in accordance with these Rules, exclusively using the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system.<\/li>\n
                                                13. The means of identification contains a labeling code comprising 4 groups of data identified by attributes (application identifiers \u2014 AI) provided for by the GS1 Data Matrix standard, of which the first and second groups of data form the identification code, or the identification code of the group package, or the identification code of the set, the third group forms the identifier (individual serial number) of the verification key, the fourth group forms the verification code:<\/li>\n
                                                14. a) the first group is identified by the application identifier AI = ’01’, consists of 14 digits and contains the product code;<\/li>\n
                                                15. b) the second group is identified by the application identifier AI = ’21’, consists of 13 characters (digits, lowercase and uppercase letters of the Latin alphabet, as well as special characters), contains the identifier of the member state of the Eurasian Economic Union in which the given code was issued (1 \u2014 Republic of Armenia, 2 \u2014 Republic of Belarus, 3 \u2014 Republic of Kazakhstan, 4 \u2014 Kyrgyz Republic, 5 \u2014 Russian Federation) (1, the first digit), and the individual serial number of the goods package (12 digits, lowercase and uppercase letters of the Latin alphabet, as well as special characters) and is terminated by the FNC1 separator character (ASCII 29);<\/li>\n
                                                16. c) the third group is identified by the application identifier AI = ’91’, consists of 4 characters, contains the identifier (individual serial number) of the verification key, which is generated by the operator of the information monitoring system, and is terminated by the FNC1 separator character (ASCII 29);<\/li>\n
                                                17. d) the fourth group is identified by the application identifier AI = ’92’, consists of 44 characters (digits, lowercase and uppercase letters of the Latin alphabet, as well as special characters) and contains the value of the verification code, which is generated by the operator of the information monitoring system.<\/li>\n
                                                18. The identification code of transport packaging shall be presented in the form of a bar code complying with the requirements of the interstate standard GOST ISO 15394-2013 “Packaging. Linear bar code symbols and two-dimensional symbols on shipping, transport and receiving labels. General requirements”, put into effect on January 1, 2014 by the order of the Federal Agency for Technical Regulation and Metrology of May 15, 2013 No. 106-st. The composition of the identification code of transport packaging shall be determined independently by the participant in the circulation of goods carrying out the aggregation of goods into transport packaging.<\/li>\n<\/ol>\n

                                                  The information monitoring system shall reflect information on the relationship of the identification codes of each nested goods in consumer packaging, and\/or group packaging, and\/or a set, and\/or transport packaging with the identification code of the transport packaging being created.<\/p>\n

                                                    \n
                                                  1. The aggregated customs code is generated by the operator of the information monitoring system, consists of a continuous sequence of 25 characters (digits, lowercase and uppercase letters of the Latin alphabet), comprising 2 groups of data, and is formed as follows:<\/li>\n<\/ol>\n

                                                     <\/p>\n

                                                     <\/p>\n

                                                    \u0425\u0425\u0425\u0425\u0425\u0425\u0425\u0425\u0425\u0425\u0425\u0425\u0414\u0414\u041c\u041c\u0413\u0413\u0425\u0425\u0425\u0425\u0425\u0425\u0425,<\/p>\n

                                                     <\/p>\n

                                                     <\/p>\n

                                                    where:<\/p>\n

                                                    the first group of data consists of 12 digits and contains the taxpayer identification number of the applicant, which is assigned automatically by the operator of the information monitoring system on the basis of the applicant’s registration data. In the event that the taxpayer identification number of the applicant consists of fewer digits, it shall be preceded by zeros (00);<\/p>\n

                                                    the second group of data consists of 13 characters (digits, lowercase and uppercase letters of the Latin alphabet). The first 6 characters of the second group of data represent the date of formation by the operator of the information monitoring system of the aggregated customs code (DDMMYY), the subsequent 7 characters of the second group of data (digits, lowercase and uppercase letters of the Latin alphabet) are generated automatically by the operator of the information monitoring system in an arbitrary (as a rule, sequential) order of assignment and ensure the uniqueness of the aggregated customs code for a period of 5 years.<\/p>\n

                                                    The aggregated customs code is generated taking into account the requirements for the customs declaration of goods as a single goods, provided for by the Procedure for Filling Out the Goods Declaration, approved by the Resolution of the Commission of the Customs Union of May 20, 2010 No. 257 (when performing customs operations and releasing goods prior to the submission of the goods declaration, taking into account the requirements for the declaration of information about goods, provided for by the Procedure for Filling Out the Application for the Release of Goods Prior to the Submission of the Goods Declaration, approved by the Resolution of the Board of the Eurasian Economic Commission of December 13, 2017 No. 171). (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/p>\n

                                                      \n
                                                    1. Means of identification in the form of a bar code shall meet the following requirements:<\/li>\n
                                                    2. a) the probability of guessing the means of identification shall be negligibly small and in any case less than 1 in 10,000;<\/li>\n
                                                    3. b) the error recognition and correction function shall be equivalent to or higher than that of Data Matrix ECC 200;<\/li>\n
                                                    4. c) it is recommended to use a module size of not less than 0.255 millimeters.<\/li>\n
                                                    5. The information monitoring system shall not permit the repeated formation (generation) of a labeling code contained in a means of identification.<\/li>\n<\/ol>\n

                                                       <\/p>\n

                                                        \n
                                                      1. Procedure for the Formation of Means of Identification<\/strong><\/li>\n
                                                      2. Within the framework of the processes specified in paragraphs 59 and 63 of these Rules, the participant in the circulation of goods shall exchange electronic documents and information with the information monitoring system by means of the emission registration device.<\/li>\n
                                                      3. For the purpose of ensuring the labeling of goods, the participant in the circulation of goods shall submit to the operator of the information monitoring system a request for the receipt of labeling codes (hereinafter \u2014 the request). The form and format of the request shall be approved by the operator of the information monitoring system.<\/li>\n
                                                      4. For the formation of the request, the participant in the circulation of goods shall submit the following information to the information monitoring system:<\/li>\n
                                                      5. a) the taxpayer identification number of the participant in the circulation of goods;<\/li>\n
                                                      6. b) the method of introduction of goods into circulation:<\/li>\n<\/ol>\n

                                                        manufactured on the territory of the Russian Federation;<\/p>\n

                                                        imported into the Russian Federation;<\/p>\n

                                                        relabeling;<\/p>\n

                                                        sale (sale) of goods previously withdrawn from circulation under a transaction, information about which constitutes a state secret;<\/p>\n

                                                        sale (sale) of goods previously acquired for purposes not related to their subsequent sale (sale);<\/p>\n

                                                        sale (sale) of goods acquired for the purpose of further sale (sale) as a result of auctions within the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in the manner of administrative or criminal proceedings, as well as as a result of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation;<\/p>\n

                                                        labeling of goods that are in circulation as of the date of the commencement of mandatory labeling of goods (labeling of residual goods);<\/p>\n

                                                          \n
                                                        1. c) the number of labeling codes requested;<\/li>\n
                                                        2. d) the product code for which it is necessary to generate a labeling code;<\/li>\n
                                                        3. e) the individual serial number of each unit of goods in the event that it is generated by the participant in the circulation of goods independently;<\/li>\n
                                                        4. f) the type of labeling code (consumer packaging, group packaging, set);<\/li>\n
                                                        5. g) the taxpayer identification number of the service provider, if the labeling of goods is to be carried out using the services of a service provider.<\/li>\n
                                                        6. The operator of the information monitoring system shall refuse to issue labeling codes in the event of a violation of one of the following requirements:<\/li>\n
                                                        7. a) the request does not comply with the requirements of paragraph 60 of these Rules;<\/li>\n
                                                        8. b) the participant in the circulation of goods is not registered in the information monitoring system;<\/li>\n
                                                        9. c) the information monitoring system does not contain information about the emission registration device used to submit the request;<\/li>\n
                                                        10. d) the identification codes, or identification codes of group packaging, or identification codes of the set specified in the request have been previously registered in the information monitoring system;<\/li>\n
                                                        11. e) the product code is not registered in the information monitoring system.<\/li>\n
                                                        12. Within 4 hours from the moment of registration of the request in the information monitoring system, the operator of the information monitoring system, using the means of the information monitoring system, shall generate the number of labeling codes specified in the request and enter the corresponding identification codes, or identification codes of group packaging, or identification codes of sets into the information monitoring system.<\/li>\n
                                                        13. After the entry of the identification codes, or identification codes of group packaging, or identification codes of sets specified in the request into the information monitoring system, the operator of the information monitoring system, by means of the information monitoring system, shall send to the emission registration device of the applicant information on the labeling codes provided pursuant to the request.<\/li>\n
                                                        14. In the case of independent labeling of goods, the participant in the circulation of goods, after receiving the labeling code, shall convert it into a means of identification, ensure the labeling of the goods, and within 30 calendar days from the date of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request, shall submit to the information monitoring system a report on the application of means of identification in the following composition:<\/li>\n<\/ol>\n

                                                          the taxpayer identification number of the participant in the circulation of goods;<\/p>\n

                                                          the labeling code converted into a means of identification applied to the consumer packaging, or group packaging, or set, or label placed on such consumer packaging, group packaging or set;<\/p>\n

                                                          the date of manufacture;<\/p>\n

                                                          the expiration date;<\/p>\n

                                                          the series (batch) number and\/or the individual factory serial number.<\/p>\n

                                                          The conversion of labeling codes paid by the participant in the circulation of goods prior to their provision by the operator of the information monitoring system, and the application of means of identification converted from such labeling codes, shall be carried out by the participant in the circulation of goods at its discretion, regardless of the period established by the first paragraph of this paragraph.<\/p>\n

                                                            \n
                                                          1. In the case of application of means of identification by a service provider, the labeling codes shall be converted by it into means of identification for application to the consumer packaging, group packaging, set, or label, with subsequent validation of the means of identification and transmission of information on the application and validation of the means of identification to the participant in the circulation of goods by means of the hardware and software complex for the distribution of labeling codes. For the transmission by the service provider of labeling codes and information on the application and validation of means of identification, the hardware and software complex for the distribution of labeling codes provided by the operator of the information monitoring system shall be used.<\/li>\n
                                                          2. After the manufacture of goods the labeling of which has been carried out by a service provider, the participant in the circulation of goods, within 365 calendar days from the date of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request, shall submit to the information monitoring system a report on the application of the means of identification in the following composition:<\/li>\n<\/ol>\n

                                                            the taxpayer identification number of the participant in the circulation of goods;<\/p>\n

                                                            the labeling code converted into a means of identification applied to the consumer packaging, or group packaging, or set, or label placed on such consumer packaging, group packaging or set;<\/p>\n

                                                            the date of manufacture;<\/p>\n

                                                            the expiration date;<\/p>\n

                                                            the series (batch) number and\/or the individual factory serial number.<\/p>\n

                                                            The conversion of labeling codes paid by the participant in the circulation of goods prior to their provision by the operator of the information monitoring system, and the application of means of identification converted from such labeling codes, shall be carried out by the participant in the circulation of goods at its discretion, regardless of the period established by the first paragraph of this paragraph.<\/p>\n

                                                              \n
                                                            1. Payment for the service of providing a labeling code, provided for by the Resolution of the Government of the Russian Federation of May 8, 2019 No. 577 “On Approval of the Amount of Fee for the Provision of Services for the Provision of Labeling Codes Necessary for the Formation of Means of Identification and Ensuring the Monitoring of the Movement of Goods Subject to Mandatory Labeling by Means of Identification, as well as on the Procedure for Its Collection”, shall be made:<\/li>\n<\/ol>\n

                                                              in the case of labeling of goods by the participant in the circulation of goods independently \u2014 prior to the date of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request, or within 30 calendar days from the said date, but no later than the date of introduction into circulation of the labeled goods, the means of identification of which has been converted from the corresponding labeling code;<\/p>\n

                                                              in the case of labeling of goods by a service provider \u2014 prior to the date of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request, or within 365 calendar days from the said date, but no later than the date of introduction into circulation of the labeled goods, the means of identification of which has been converted from the corresponding labeling code.<\/p>\n

                                                              At the same time, the operator of the information monitoring system shall enter into the information monitoring system information on the application of the means of identification specified by the participant in the circulation of goods in the report on the application of the means of identification only after receipt of payment for the service of providing the labeling code converted into the corresponding means of identification.<\/p>\n

                                                              The decision on the choice of the method of payment for the service of providing a labeling code shall be made by the participant in the circulation of goods.<\/p>\n

                                                              In the event that payment for the service of providing a labeling code is made by the participant in the circulation of goods prior to the date of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request, such service shall be deemed to be rendered by the operator of the information monitoring system at the moment of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request.<\/p>\n

                                                              In the event that payment for the service of providing a labeling code is made by the participant in the circulation of goods after the date of provision by the operator of the information monitoring system to the participant in the circulation of goods of information on the labeling codes provided pursuant to the request, such service shall be deemed to be rendered by the operator of the information monitoring system at the moment of entry by the operator of the information monitoring system into the information monitoring system of information on the labeling of goods specified by the participant in the circulation of goods in the report on the application of the means of identification.<\/p>\n

                                                                \n
                                                              1. In the event that a participant in the circulation of goods that has received labeling codes on a gratuitous basis has not, as of September 30, 2023 (inclusive), ensured their conversion into means of identification and has not submitted to the information monitoring system a report on the application of means of identification and information on the introduction of goods into circulation by the said date, then, from October 1, 2023, the participant in the circulation of goods shall have the right to introduce into circulation goods labeled with means of identification converted from such labeling codes, subject to compliance with the period for submission to the information monitoring system of the report on the application of means of identification established by paragraphs 64 and\/or 66 of these Rules, and payment for the said labeling codes in accordance with this paragraph.<\/li>\n<\/ol>\n

                                                                The service of providing a labeling code in the case provided for by the first paragraph of this paragraph shall be deemed to be rendered by the operator of the information monitoring system at the moment of entry by the operator of the information monitoring system into the information monitoring system of information on the introduction of goods into circulation specified by the participant in the circulation of goods in the notification of the introduction of the corresponding goods into circulation.<\/p>\n

                                                                At the same time, the operator of the information monitoring system shall enter into the information monitoring system information on the introduction of goods into circulation after receipt of payment for the service of providing the labeling code.<\/p>\n

                                                                Payment for the said service, provided for by the Resolution of the Government of the Russian Federation of May 8, 2019 No. 577 “On Approval of the Amount of Fee for the Provision of Services for the Provision of Labeling Codes Necessary for the Formation of Means of Identification and Ensuring the Monitoring of the Movement of Goods Subject to Mandatory Labeling by Means of Identification, as well as on the Procedure for Its Collection”, shall be made:<\/p>\n

                                                                in the case of labeling of goods by the participant in the circulation of goods independently \u2014 within 30 calendar days, starting from October 1, 2023, but no later than the date of introduction into circulation of the labeled goods, the means of identification of which have been converted from the corresponding labeling codes received as of September 30, 2023 (inclusive);<\/p>\n

                                                                in the case of labeling of goods by a service provider \u2014 subject to payment for the said labeling codes within 365 calendar days, starting from October 1, 2023, but no later than the date of introduction into circulation of the labeled goods, the means of identification of which have been converted from the corresponding labeling codes.<\/p>\n

                                                                  \n
                                                                1. Labeling codes shall be cancelled in the following cases:<\/li>\n
                                                                2. a) the participant in the circulation of goods has not made payment for the services of providing these labeling codes within the periods established by paragraphs 67 or 68 of these Rules;<\/li>\n
                                                                3. b) the participant in the circulation of goods has not submitted to the information monitoring system a report on the application of means of identification converted from these labeling codes within the periods established by paragraphs 64 and\/or 66 of these Rules.<\/li>\n
                                                                4. Refusal to enter by the operator of the information monitoring system into the information monitoring system of information on the application of means of identification shall be made for the following reasons:<\/li>\n
                                                                5. a) the absence in the information monitoring system of the identification codes specified in the report on the application of means of identification;<\/li>\n
                                                                6. b) the submission by the participant in the circulation of goods of the report on the application of means of identification after the expiration of the period established by paragraphs 64 and\/or 66 of these Rules;<\/li>\n
                                                                7. c) the absence in the information monitoring system of information about the emission registration device used by the participant in the circulation of goods to submit the report on the application of means of identification;<\/li>\n
                                                                8. d) the absence, on the part of the operator of the information monitoring system, of confirmation of payment for the labeling codes converted into means of identification, the report on the application of which is to be submitted to the information monitoring system in accordance with paragraphs 64 and\/or 66 of these Rules.<\/li>\n<\/ol>\n

                                                                   <\/p>\n

                                                                  VII. Procedure for the Application of Means of Identification<\/strong><\/p>\n

                                                                    \n
                                                                  1. The labeling of goods shall be carried out by the manufacturer or the importer, including with the use of the services of a service provider:<\/li>\n
                                                                  2. a) in the case of production of goods on the territory of the Russian Federation, including from foreign raw materials and\/or components previously placed under the customs procedure of a free customs zone or under the customs procedure of a free warehouse, at the places of production or storage of goods \u2014 prior to the introduction of goods into circulation;<\/li>\n
                                                                  3. b) in the cases of importation of goods into the Russian Federation:<\/li>\n<\/ol>\n

                                                                    from the territory of states that are not members of the Eurasian Economic Union, as well as in the case of importation into the remaining part of the territory of the Russian Federation of goods produced in the territories of special (free) economic zones or territories equivalent thereto from foreign raw materials and\/or components placed under the customs procedure of a free customs zone, as well as goods produced in the territory of a free warehouse from foreign raw materials and\/or components placed under the customs procedure of a free warehouse \u2014 prior to their placement under the customs procedures of release for domestic consumption or re-import;<\/p>\n

                                                                    from the territory of member states of the Eurasian Economic Union within the framework of cross-border trade \u2014 prior to movement across the state border of the Russian Federation.<\/p>\n

                                                                      \n
                                                                    1. Participants in the circulation of goods that have made a decision to sell goods acquired for purposes not related to their subsequent sale (sale), or to sell (sell) goods acquired from a party to a transaction, information about which constitutes a state secret, or acquired as a result of auctions within the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in the manner of administrative and criminal proceedings, as well as as a result of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation, shall ensure the labeling of unlabeled goods prior to their sale (sale) to third parties, including prior to their display at the place of sale (sale), demonstration of their samples.<\/li>\n
                                                                    2. Participants in the circulation of goods shall ensure the relabeling of goods supplied (sold) within the framework of purchase and sale transactions, as well as commission agreements, including those offered for sale (sale) after their return by the buyer, in the event of loss or damage to the means of identification precluding the possibility of its reading (recognition).<\/li>\n
                                                                    3. In the case of the formation of a set, the means of identification shall be applied to the set or a label placed on such set, as well as to the consumer packaging of the goods included in the composition of such set, or a label placed on such consumer packaging.<\/li>\n
                                                                    4. The means of identification shall be applied to the consumer packaging, or group packaging, or set, or a label placed on such consumer or group packaging, or set, by a method that does not allow the separation of the means of identification without damage to the means of identification.<\/li>\n<\/ol>\n

                                                                      The means of identification may not be applied to structurally separable parts of the consumer packaging that can be separated without damage, and shall not be printed on transparent wrapping film or on any other external wrapping material.<\/p>\n

                                                                        \n
                                                                      1. The location of the means of identification applied to the consumer packaging, or group packaging, or set, shall ensure unobstructed reading by technical means intended for reading codes in Data Matrix and EAN-128 format.<\/li>\n<\/ol>\n

                                                                        At the same time, the means of identification shall be located in such a way as not to violate the integrity of the information applied to the consumer packaging, or group packaging, or set in accordance with the requirements of the legislation on technical regulation.<\/p>\n

                                                                         <\/p>\n

                                                                        VIII. <\/strong>Procedure and Timeframes for the Submission by Participants in the Circulation of Goods to the Information Monitoring System of Information on the Introduction into Circulation, Circulation, and Withdrawal from Circulation of Goods for Their Inclusion in the Information Monitoring System<\/strong><\/p>\n

                                                                          \n
                                                                        1. Manufacturers (including within the framework of contract manufacturing), prior to offering goods for wholesale or retail sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples (with the exception of the submission of information on goods when they are sold by remote method), or third-party manufacturers of goods prior to the transfer of goods to the manufacturer, shall form a notification of the introduction of goods into circulation and submit the following information to the information monitoring system:<\/li>\n<\/ol>\n

                                                                          the taxpayer identification number of the manufacturer;<\/p>\n

                                                                          the 10-digit code of the commodity nomenclature;<\/p>\n

                                                                          the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging;<\/p>\n

                                                                          the type of production order (own production, contract manufacturing);<\/p>\n

                                                                          the taxpayer identification number of the owner of the goods (in the case of contract manufacturing);<\/p>\n

                                                                          the registration number and date of issuance (registration) of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/p>\n

                                                                          the date and number of the registration certificate for the medical device.<\/p>\n

                                                                          The submission of information on the transfer of goods manufactured within the framework of contract manufacturing from the third-party manufacturer of goods to the manufacturer shall be carried out in accordance with paragraph 94 of these Rules.<\/p>\n

                                                                            \n
                                                                          1. Importers, after the release by customs authorities of goods imported (brought) and placed under the customs procedures of release for domestic consumption or re-import, prior to the offering of these goods for sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples, or prior to the recording of goods imported into the Russian Federation for purposes not related to their subsequent sale (sale), shall form a notification of the introduction of goods into circulation and submit the following information to the information monitoring system:<\/li>\n
                                                                          2. a) the taxpayer identification number of the importer;<\/li>\n
                                                                          3. b) the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code;<\/li>\n
                                                                          4. c) the date of registration of the goods declaration or other document used as a goods declaration, on the basis of which the release of goods was carried out in accordance with the customs procedures of release for domestic consumption or re-import (hereinafter \u2014 the customs document); (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                          5. d) the registration number of the customs document; (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                          6. e) the registration number and date of issuance (registration) of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/li>\n
                                                                          7. f) the date and number of the registration certificate for the medical device.<\/li>\n
                                                                          8. For the purposes of customs declaration of goods and submission to the information monitoring system of a notification of the introduction of goods into circulation taking into account the requirements provided for by paragraph 78 of these Rules, the identification codes, and\/or identification codes of group packaging, and\/or identification codes of sets, and\/or identification codes of transport packaging, and\/or the aggregated customs code shall be indicated in customs documents in accordance with the Procedure for Filling Out the Goods Declaration, approved by the Resolution of the Commission of the Customs Union of May 20, 2010 No. 257, or the Procedure for Filling Out the Application for the Release of Goods Prior to the Submission of the Goods Declaration, approved by the Resolution of the Board of the Eurasian Economic Commission of December 13, 2017 No. 171. (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n<\/ol>\n

                                                                            At the same time, it is not permitted to indicate in customs documents identification codes, and\/or identification codes of group packaging, and\/or identification codes of sets, and\/or identification codes of transport packaging, and\/or the aggregated customs code already contained in another customs document or in the same customs document, with the exception of cases where a decision is made to refuse release, recall, or cancel the customs document, as well as the indication in the goods declaration submitted in respect of goods the release of which was carried out on the basis of the application for the release of goods prior to the submission of the goods declaration. (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/p>\n

                                                                            In the customs declaration of goods in accordance with the customs procedures of release for domestic consumption or re-import upon completion of the customs procedures of a free customs zone and a free warehouse for the purposes of export of a manufactured and introduced into circulation goods from the territories of special (free) economic zones, territories equivalent thereto, and territories of free warehouses to the remaining part of the territory of the Russian Federation, the identification codes, and\/or identification codes of group packaging, and\/or identification codes of sets, or identification codes of transport packaging, or the aggregated customs code shall not be indicated in the goods declaration. (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/p>\n

                                                                              \n
                                                                            1. The aggregated customs code shall be generated by the operator of the information monitoring system on the basis of a request submitted by the importer to the information monitoring system and containing the following information:<\/li>\n
                                                                            2. a) the taxpayer identification number of the importer;<\/li>\n
                                                                            3. b) the list of identification codes, and\/or identification codes of group packaging, and\/or identification codes of sets to be included in the aggregated customs code.<\/li>\n
                                                                            4. Participants in the circulation of goods carrying out, within the framework of cross-border trade, the import of goods into the Russian Federation from the customs territory of member states of the Eurasian Economic Union, prior to their display at the place of sale (sale), demonstration of their samples or the submission of information about them at the place of sale (sale) of goods, shall form a notification of the introduction of goods into circulation and submit the following information to the information monitoring system:<\/li>\n
                                                                            5. a) the taxpayer identification number of the participant in the circulation of goods carrying out the import of goods within the framework of cross-border trade;<\/li>\n
                                                                            6. b) the 10-digit code of the commodity nomenclature;<\/li>\n
                                                                            7. c) the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging;<\/li>\n
                                                                            8. d) the name of the member state of the Eurasian Economic Union from whose territory the import of goods is carried out (in accordance with the All-Russian Classifier of Countries of the World);<\/li>\n
                                                                            9. e) the value of labeled goods (including value-added tax, if the transaction is subject to such tax) according to primary documents;<\/li>\n
                                                                            10. f) the name of the supplier organization;<\/li>\n
                                                                            11. g) the taxpayer identification number of the sender (or its equivalent in the sender’s country);<\/li>\n
                                                                            12. h) the details of the accompanying document confirming the import of goods into the Russian Federation from the territory of another member state of the Eurasian Economic Union;<\/li>\n
                                                                            13. i) the registration number and date of issuance (registration) of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/li>\n
                                                                            14. j) the date and number of the registration certificate for the medical device.<\/li>\n
                                                                            15. The information monitoring system shall transmit to the Unified Automated Information System of Customs Authorities, upon request of the Unified Automated Information System of Customs Authorities, the following information on labeled goods:<\/li>\n
                                                                            16. a) the name of the owner of the identification codes, or identification codes of group packaging, or identification codes of sets, or identification codes of transport packaging, or the aggregated customs code;<\/li>\n
                                                                            17. b) the taxpayer identification number, the name of the taxpayer of the owner of the identification codes, or identification codes of group packaging, or identification codes of sets, or identification codes of transport packaging, or the aggregated customs code;<\/li>\n
                                                                            18. c) the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or the aggregated customs code;<\/li>\n
                                                                            19. d) the status of the identification code, or the status of the identification code of group packaging, or the status of the identification code of a set, or the status of the identification code of transport packaging, or the status of the aggregated customs code;<\/li>\n
                                                                            20. e) the number of units of goods declared under the identification code of group packaging, or under the identification code of a set, or under the identification code of transport packaging, or under the aggregated customs code;<\/li>\n
                                                                            21. f) the date of the last change in the status of the identification code, or the status of the identification code of group packaging, or the status of the identification code of a set, or the status of the identification code of transport packaging, or the status of the aggregated customs code;<\/li>\n
                                                                            22. g) the date of acceptance of the identification code, identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code at the warehouse;<\/li>\n
                                                                            23. h) the 10-digit code of the commodity nomenclature;<\/li>\n
                                                                            24. i) the code of the reason for registration of the participant in the circulation of goods (if available);<\/li>\n
                                                                            25. j) the registration number of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/li>\n
                                                                            26. k) the date of issuance (registration) of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/li>\n
                                                                            27. l) the date of the registration certificate for the medical device;<\/li>\n
                                                                            28. m) the number of the registration certificate for the medical device;<\/li>\n
                                                                            29. n) the trademark (if available).<\/li>\n
                                                                            30. The Unified Automated Information System of Customs Authorities shall transmit to the information monitoring system, upon request of the information monitoring system, the following information on the results of customs control of labeled goods:<\/li>\n
                                                                            31. a) the type of customs document; (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n<\/ol>\n

                                                                              a.1) the code of the customs authority that made the decision on the customs document; (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/p>\n

                                                                                \n
                                                                              1. b) the registration number and date of issuance (registration) of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/li>\n
                                                                              2. c) the date and number of the registration certificate for the medical device;<\/li>\n
                                                                              3. d) the registration number of the customs document; (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                              4. e) the date of registration of the customs document; (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                              5. f) the code of the customs procedure;<\/li>\n
                                                                              6. g) the code of the declaration feature;<\/li>\n
                                                                              7. h) the name of the sending organization;<\/li>\n
                                                                              8. i) the code of the sender’s country;<\/li>\n
                                                                              9. j) the name of the sender’s country;<\/li>\n
                                                                              10. k) the name of the receiving organization;<\/li>\n
                                                                              11. l) the taxpayer identification number of the recipient;<\/li>\n
                                                                              12. m) the name of the organization (individual entrepreneur) of the declarant of the goods;<\/li>\n
                                                                              13. n) the taxpayer identification number of the declarant of the goods;<\/li>\n
                                                                              14. o) the 10-digit code of the commodity nomenclature;<\/li>\n
                                                                              15. p) the 3-digit alphabetic code of the currency of the contract price;<\/li>\n
                                                                              16. q) the customs value of the goods;<\/li>\n
                                                                              17. r) the price of the goods (invoice value); (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                              18. s) the code of the country of origin in accordance with the All-Russian Classifier of Countries of the World;<\/li>\n
                                                                              19. t) the quantity of goods in the supplementary unit of measurement;<\/li>\n
                                                                              20. u) the name of the supplementary unit of measurement;<\/li>\n
                                                                              21. v) the code of the supplementary unit of measurement;<\/li>\n
                                                                              22. w) the name of the goods; (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                              23. x) the serial number of the goods (goods); (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/li>\n
                                                                              24. y) the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code;<\/li>\n
                                                                              25. z) the amount of value-added tax paid to the budget of the Russian Federation in respect of the imported goods;<\/li>\n
                                                                              26. aa) the gross weight, the net weight;<\/li>\n
                                                                              27. bb) the code of the decision on the goods in accordance with the classifier of decisions made by the customs authority;<\/li>\n
                                                                              28. cc) the date and time of the adopted decision on the goods in accordance with the classifier of decisions.<\/li>\n<\/ol>\n

                                                                                84 n the event of amendments (additions) to the information declared in the goods declaration after the release of the goods, the Unified Automated Information System of Customs Authorities shall transmit, upon request, to the information monitoring system the adjusted data on the goods, as well as information on the goods declaration submitted in respect of goods the release of which was carried out on the basis of the application for the release of goods prior to the submission of the goods declaration. (as amended by Resolution of the Government of the Russian Federation of November 26, 2024 No. 1630)<\/p>\n

                                                                                  \n
                                                                                1. Information on the decision of the customs authority in respect of labeled goods, obtained from the Unified Automated Information System of Customs Authorities, shall be reflected in the information monitoring system.<\/li>\n
                                                                                2. Participants in the circulation of goods that have made a decision to sell goods acquired as a result of auctions within the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in the manner of administrative or criminal proceedings, as well as as a result of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation, shall form a notification of the introduction of goods into circulation and enter the following information into the information monitoring system prior to the offering of these goods for sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples:<\/li>\n
                                                                                3. a) the taxpayer identification number of the participant in the circulation of goods carrying out the said circulation;<\/li>\n
                                                                                4. b) the identification code, or identification code of group packaging, or identification code of a set;<\/li>\n
                                                                                5. c) the details of the primary accounting document confirming the acceptance of goods acquired as a result of auctions within the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in the manner of administrative or criminal proceedings, as well as as a result of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation.<\/li>\n
                                                                                6. Participants in the circulation of goods shall have the right, prior to the introduction of goods into circulation, to post information about such goods, including the description of the goods, their image and value, on the Internet when selling goods by remote method, in catalogs, prospectuses, booklets, photographs, communication means (television, postal, radio communication, and others), or by other methods excluding the possibility of the consumer’s direct acquaintance with the goods or their samples for the purpose of selling (selling) goods by remote method, as well as to conclude retail purchase and sale contracts for goods by remote method with consumers with the acceptance of advance payments or prepayment for the said goods. Delivery of goods to consumers on the basis of a retail purchase and sale contract by remote method concluded prior to the introduction of goods into circulation shall be permitted only after the introduction of goods into circulation.<\/li>\n
                                                                                7. Participants in the circulation of goods shall, if necessary, carry out the operation of formation of a set and submit to the information monitoring system, prior to the offering of this set for sale (sale), including prior to its display at the place of sale (sale), demonstration of its samples (with the exception of the submission of information about it when selling goods by remote method), the following information:<\/li>\n
                                                                                8. a) the taxpayer identification number of the participant in the circulation of goods;<\/li>\n
                                                                                9. b) the identification code of the set;<\/li>\n
                                                                                10. c) the list of identification codes of the goods included in the set.<\/li>\n
                                                                                11. When aggregating consumer packages into group packaging, prior to the transfer of the group packaging to the next participant in the circulation of goods, the participant in the circulation of goods that has carried out the aggregation shall submit the following information to the information monitoring system:<\/li>\n<\/ol>\n

                                                                                  the identification code of the group packaging;<\/p>\n

                                                                                  the list of identification codes of the aggregated consumer packages;<\/p>\n

                                                                                  the date of aggregation.<\/p>\n

                                                                                  Information on the aggregation of goods in consumer packages into group packaging may be transmitted simultaneously with information on the aggregation of group packages into transport packaging prior to the transfer of the transport packaging to the next participant in the circulation of goods.<\/p>\n

                                                                                    \n
                                                                                  1. Participants in the circulation of goods carrying out the operation of aggregation of goods into transport packaging shall submit the following information to the information monitoring system:<\/li>\n
                                                                                  2. a) the result of the performance of the first-level aggregation operation by submitting the following information:<\/li>\n<\/ol>\n

                                                                                    the taxpayer identification number of the participant in the circulation of goods that carried out the aggregation of goods into the first-level transport packaging;<\/p>\n

                                                                                    the identification code of the transport packaging being created, as well as the list of identification codes, and\/or identification codes of group packaging, and\/or identification codes of sets to be included in the identification code of the transport packaging being created;<\/p>\n

                                                                                      \n
                                                                                    1. b) the result of the performance of the subsequent-level aggregation operation by submitting the following information:<\/li>\n<\/ol>\n

                                                                                      the taxpayer identification number of the participant in the circulation of goods that carried out the aggregation of goods into the subsequent-level transport packaging;<\/p>\n

                                                                                      the identification code of the higher-level transport packaging being created, as well as the list of identification codes of transport packaging to be included in the identification code of the higher-level transport packaging being created.<\/p>\n

                                                                                        \n
                                                                                      1. Participants in the circulation of goods carrying out the operation of disbanding of transport packaging shall submit the following information to the information monitoring system:<\/li>\n<\/ol>\n

                                                                                        the taxpayer identification number of the participant in the circulation of goods that carried out the disbanding of the transport packaging;<\/p>\n

                                                                                        the identification codes of the transport packaging to be disbanded.<\/p>\n

                                                                                        In the event of submission by participants in the circulation of goods to the information monitoring system of information on the circulation or withdrawal from circulation of part of the goods that are, according to the data of the information monitoring system, in transport packaging, the disbanding of all transport packaging of a higher nesting level that contained the goods removed from the said packaging shall be automatically registered in the information monitoring system.<\/p>\n

                                                                                          \n
                                                                                        1. Participants in the circulation of goods shall, if necessary, carry out the operation of disbanding of group packaging or a set and submit the following information to the information monitoring system:<\/li>\n
                                                                                        2. a) the taxpayer identification number of the participant in the circulation of goods that carried out the operation of disbanding of the group packaging or set;<\/li>\n
                                                                                        3. b) the list of identification codes of group packaging to be disbanded, or identification codes of sets to be disbanded.<\/li>\n
                                                                                        4. Participants in the circulation of goods carrying out operations for the removal or rearrangement of goods within the first-level transport packaging or the first-level transport packaging within the subsequent-level transport packaging shall submit the following information to the information monitoring system:<\/li>\n<\/ol>\n

                                                                                          the taxpayer identification number of the participant in the circulation of goods that carried out the operations for removal or rearrangement;<\/p>\n

                                                                                          the type of transformation operation (rearrangement, removal);<\/p>\n

                                                                                          the list of identification codes, and\/or identification codes of group packaging, and\/or identification codes of sets, and\/or identification codes of transport packaging to be transformed.<\/p>\n

                                                                                          The disbanding of the identification code of the first and subsequent levels of transport packaging shall be carried out only if, as a result of the transformation operation of the packaging, no other first-level transport packaging, or goods in consumer packages, or goods in group packages, or sets in the first-level transport packaging remain.<\/p>\n

                                                                                            \n
                                                                                          1. Upon the transfer (acceptance) of goods within the framework of transactions involving the transfer of ownership of the said goods, as well as within the framework of commission agreements, and\/or agency agreements, and\/or contract agreements, and\/or mandate agreements, the participant in the circulation of goods carrying out the shipment (acceptance) of goods shall form a notification of the transfer (acceptance) of goods (in the format of a universal transfer document indicating the type of transaction within the framework of which the shipment is carried out), sign it with an enhanced electronic signature, and send it to the other party to the transaction in the procedure provided for by paragraph 23 of these Rules, and no later than 3 working days from the date of acceptance of the goods, such notification shall be sent to the information monitoring system by the electronic document flow operator.<\/li>\n<\/ol>\n

                                                                                            The said notification must contain the following mandatory information:<\/p>\n

                                                                                            the taxpayer identification number of the buyer;<\/p>\n

                                                                                            the unit of measurement (code and its corresponding conventional designation (national) in accordance with the All-Russian Classifier of Units of Measurement) (if available);<\/p>\n

                                                                                            the number of supplied (shipped) goods;<\/p>\n

                                                                                            the price of the goods per unit of measurement excluding value-added tax, and in the case of the application of state-regulated prices (tariffs) including value-added tax, including the amount of the tax;<\/p>\n

                                                                                            the value of the entire quantity of supplied (shipped) goods excluding value-added tax (in cases provided for by the Tax Code of the Russian Federation, the tax base shall be indicated);<\/p>\n

                                                                                            the tax rate;<\/p>\n

                                                                                            the value of the entire quantity of supplied (shipped) goods including the amount of value-added tax;<\/p>\n

                                                                                            the amount of value-added tax presented to the buyer of the goods;<\/p>\n

                                                                                            the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging.<\/p>\n

                                                                                              \n
                                                                                            1. The operator of the information monitoring system, after receipt of a notification from the electronic document flow operator or an acceptance document in the procedure provided for by paragraph 33 of these Rules, shall reflect in the information monitoring system the fact of the transfer of goods between participants in the circulation of goods.<\/li>\n
                                                                                            2. Participants in the circulation of goods carrying out the sale of labeled goods using cash register equipment shall send to the information monitoring system information on the circulation of goods, if the operation is carried out between participants in the circulation of goods registered in the information monitoring system, or on the withdrawal from circulation of goods by means of cash register equipment, and when carrying out operations to adjust the initially submitted information on the price of the goods per unit including discounts, markups, fees, and taxes, the value of the goods including discounts, markups, fees, and taxes, the rate of value-added tax included in the value of the goods, on the withdrawal from circulation of labeled goods by means of cash register equipment, shall send to the information monitoring system information on the adjustment of the withdrawal from circulation of goods by means of cash register equipment.<\/li>\n
                                                                                            3. A participant in the circulation of goods carrying out the sale of goods using cash register equipment shall identify and recognize, by means of software and\/or hardware integrated with the cash register equipment installed and registered by it, the means of identification applied to the goods.<\/li>\n
                                                                                            4. In the presence of a contract with a participant in the circulation of goods carrying out settlements for goods or the acceptance of returned goods with an undamaged means of identification in accordance with the Federal Law “On the Use of Cash Register Equipment When Making Settlements in the Russian Federation”, the fiscal data operator, on behalf of such participant in the circulation of goods, shall carry out on its behalf a daily real-time transmission of the information received from it to the operator of the information monitoring system for each sold unit of labeled goods in accordance with the information exchange protocol between the fiscal data operator and the information monitoring system, including the following mandatory information:<\/li>\n
                                                                                            5. a) the taxpayer identification number of the user of the cash register equipment (except in cases established by the Federal Law “On the Use of Cash Register Equipment When Making Settlements in the Russian Federation”);<\/li>\n
                                                                                            6. b) the code of the document form;<\/li>\n
                                                                                            7. c) the serial number of the document;<\/li>\n
                                                                                            8. d) the date and time of generation of the document;<\/li>\n
                                                                                            9. e) the sign of settlement \u2014 receipt (receipt of funds from the buyer), return of receipt (return of funds received from the buyer to the buyer), expense (issuance of funds to the buyer), return of expense (receipt of funds issued to the buyer from the buyer);<\/li>\n
                                                                                            10. f) the labeling code, or identification code, or identification code of group packaging, or identification code of a set as part of the “goods code” attribute;<\/li>\n
                                                                                            11. g) data on each unit of goods (the status of the goods (if available), the price per unit of the settlement item including discounts and markups, fees and taxes, the number of units of goods, the value of the settlement item including discounts and markups, fees and taxes, with an indication of the rate of value-added tax included in the value of the goods);<\/li>\n
                                                                                            12. h) the registration number of the cash register equipment;<\/li>\n
                                                                                            13. i) the factory number of the fiscal storage;<\/li>\n
                                                                                            14. j) the address and place of settlement (except in cases established by the Federal Law “On the Use of Cash Register Equipment When Making Settlements in the Russian Federation”);<\/li>\n
                                                                                            15. k) the taxation system applied by the user when making settlements for labeled goods;<\/li>\n
                                                                                            16. l) the taxpayer identification number of the buyer (client) (when making settlements using cash register equipment between organizations and\/or individual entrepreneurs);<\/li>\n
                                                                                            17. m) data on the sale of a disassembled consumer package (the number of sold unlabeled parts and the total number of parts in the consumer package).<\/li>\n
                                                                                            18. Information on the making of settlements using cash register equipment between participants in the circulation of goods shall be equated to the notification of the transfer (acceptance) of goods provided for by paragraph 94 of these Rules and shall be the basis for the reflection by the operator of the information monitoring system in the information monitoring system of the fact of the transfer and acceptance of goods.<\/li>\n
                                                                                            19. In the absence of a contract with the fiscal data operator for the carrying out on behalf of and on the instructions of the participant in the circulation of goods of the transmission of information to the operator of the information monitoring system, or in the absence of the technical capability of the fiscal data operator to carry out on behalf of and on the instructions of the participant in the circulation of goods the transmission of information on the sale of labeled goods received from the cash register equipment of the participant in the circulation of goods, the transmission of information on the circulation of goods in the event that the operation is carried out between participants in the circulation of goods registered in the information monitoring system, or on the withdrawal from circulation of goods, the obligation to transmit information on the circulation of labeled goods or on the withdrawal of goods from circulation using cash register equipment shall be fulfilled by the participant in the circulation of goods no later than 30 calendar days from the date of sale of the goods through the personal account of the participant in the circulation of goods or by means of information electronic services using standard data transmission protocols and electronic interaction interfaces of the information monitoring system.<\/li>\n
                                                                                            20. A notification of the registration in the information monitoring system of information on the circulation of labeled goods, in the event that the operation is carried out between participants in the circulation of goods registered in the information monitoring system, or on the withdrawal of goods from circulation, or of the refusal to register such information, shall be sent to the fiscal data operator and\/or to the participant in the circulation of goods that carried out the sale of goods using cash register equipment, and\/or to the participants in the circulation that carried out the receipt and transfer of goods using cash register equipment.<\/li>\n
                                                                                            21. In the case of the use of cash register equipment in a mode that does not provide for the mandatory transmission of fiscal documents to the tax authorities and the information monitoring system in electronic form through the fiscal data operator, as well as in the event that the participant in the circulation of goods falls under the provisions of paragraphs 2 and 3 of Article 2 of the Federal Law “On the Use of Cash Register Equipment When Making Settlements in the Russian Federation”, participants in the circulation of goods shall independently, no later than 30 calendar days from the date of sale of the goods, send to the information monitoring system information on the withdrawal of goods from circulation or on the circulation of labeled goods, in the event that the operation is carried out between participants in the circulation of goods registered in the information monitoring system, containing the information provided for by paragraph 98 of these Rules, through the personal account of the participant in the circulation of goods or by means of information electronic services using standard data transmission protocols and electronic interaction interfaces of the information monitoring system.<\/li>\n
                                                                                            22. In the event of the return of labeled goods by the consumer in accordance with the legislation of the Russian Federation on consumer protection, the participant in the circulation of goods shall submit to the information monitoring system, prior to the offering of such goods for sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples, information by one of the following methods:<\/li>\n<\/ol>\n

                                                                                              using cash register equipment through the fiscal data operator in accordance with the procedures provided for by paragraphs 96 \u2014 101 of these Rules, independently or with the involvement of other legal entities or individual entrepreneurs authorized by the participant in the circulation of goods and acting on its behalf in accordance with the legislation of the Russian Federation;<\/p>\n

                                                                                              independently enters the following information into the information monitoring system:<\/p>\n

                                                                                              the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                              the identification code, or identification code of group packaging, or identification code of a set, returned to circulation (in the case of the return of goods with an undamaged means of identification);<\/p>\n

                                                                                              a new identification code, or a new identification code of group packaging, or a new identification code of a set (in the case of the return of goods with a damaged means of identification or without a means of identification);<\/p>\n

                                                                                              the details of the documents confirming the return of labeled goods.<\/p>\n

                                                                                              When returning goods with a damaged means of identification or without a means of identification (the possibility of identifying the goods is absent), the participant in the circulation of goods shall, prior to the submission to the information monitoring system of the information provided for by the fourth to seventh paragraphs of this paragraph, carry out the relabeling of such goods in accordance with paragraphs 73 and 118 of these Rules.<\/p>\n

                                                                                                \n
                                                                                              1. Upon the withdrawal of goods from circulation on grounds that are not retail sale, with the exception of the cases provided for by paragraphs 106, 108, 109, 111, and 114 of these Rules, the participant in the circulation of goods carrying out their withdrawal from circulation shall, within 3 working days, submit the following information on the withdrawal of goods from circulation to the information monitoring system:<\/li>\n
                                                                                              2. a) the taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;<\/li>\n
                                                                                              3. b) the reason for the withdrawal of goods from circulation (destruction, expiration of shelf life, loss, use for medical application, and other);<\/li>\n
                                                                                              4. c) the name, date, and number of the primary document on the disposal of goods from circulation;<\/li>\n
                                                                                              5. d) the identification code, and\/or identification code of group packaging, and\/or identification code of a set, withdrawn from circulation.<\/li>\n
                                                                                              6. In the event of the return of goods previously withdrawn from circulation on the grounds of the use of the goods for medical application, such participant in the circulation of goods shall independently submit the following information to the information monitoring system:<\/li>\n
                                                                                              7. a) the taxpayer identification number of the participant in the circulation of goods carrying out the return of goods to circulation;<\/li>\n
                                                                                              8. b) the reason for the return of goods to circulation (return of goods withdrawn from circulation for medical application);<\/li>\n
                                                                                              9. c) the identification code, or identification code of group packaging, or identification code of a set, returned to circulation.<\/li>\n
                                                                                              10. Upon the withdrawal of goods from circulation by their sale by sample or by remote method, including using a vending machine or a parcel locker, the participant in the circulation of goods shall transmit to the information monitoring system by one of the following methods:<\/li>\n<\/ol>\n

                                                                                                using cash register equipment through the fiscal data operator, information in accordance with paragraphs 96 \u2014 101 of these Rules, independently or with the involvement of other legal entities or individual entrepreneurs authorized by the participant in the circulation of goods and acting on its behalf in accordance with the legislation of the Russian Federation;<\/p>\n

                                                                                                independently, no later than 3 working days following the day of shipment of the goods from the storage warehouse for delivery to a vending machine or parcel locker, or no later than the date of actual delivery of the goods to the consumer:<\/p>\n

                                                                                                the taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;<\/p>\n

                                                                                                the reason for the withdrawal of goods from circulation (sale of goods by sample, remote method of sale of goods, sale of goods using a vending machine or parcel locker);<\/p>\n

                                                                                                the name, date, and number (if available) of the primary document on the disposal of goods from circulation;<\/p>\n

                                                                                                the identification code, and\/or identification code of group packaging, and\/or identification code of a set, withdrawn from circulation;<\/p>\n

                                                                                                the value of the goods withdrawn from circulation (according to the accounting data of the participant in the circulation of goods).<\/p>\n

                                                                                                  \n
                                                                                                1. In the event of the return of goods previously withdrawn from circulation by sale by sample or by remote method, including using a vending machine or parcel locker, to the storage warehouse of the participant in the circulation of goods, such participant in the circulation of goods shall, prior to the offering of these goods for sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples (with the exception of the submission of information about them when selling goods by remote method), submit information to the information monitoring system by one of the following methods:<\/li>\n<\/ol>\n

                                                                                                  using cash register equipment through the fiscal data operator, information in accordance with the procedures provided for by paragraphs 96 \u2014 101 of these Rules, independently or with the involvement of other legal entities or individual entrepreneurs authorized by the participant in the circulation of goods and acting on its behalf in accordance with the legislation of the Russian Federation;<\/p>\n

                                                                                                  independently enters the following information into the information monitoring system:<\/p>\n

                                                                                                  the taxpayer identification number of the participant in the circulation of goods carrying out the return of goods to circulation;<\/p>\n

                                                                                                  the reason for the return of goods to circulation (return of goods sold by remote method, return of goods sold using a vending machine or parcel locker);<\/p>\n

                                                                                                  the identification code, or identification code of group packaging, or identification code of a set, returned to circulation (in the case of the return of goods with an undamaged means of identification);<\/p>\n

                                                                                                  a new identification code, or a new identification code of group packaging, or a new identification code of a set (in the case of the return of goods with a damaged means of identification or without a means of identification).<\/p>\n

                                                                                                  When returning goods with a damaged means of identification or without a means of identification (the possibility of identifying the goods is absent), the participant in the circulation of goods shall, prior to the submission to the information monitoring system of the information provided for by the fourth to seventh paragraphs of this paragraph, carry out the relabeling of such goods in accordance with paragraphs 73 and 118 of these Rules.<\/p>\n

                                                                                                    \n
                                                                                                  1. Upon the withdrawal of goods from circulation on the grounds of placing labeled goods under the customs procedure of export, the participant in the circulation of goods carrying out the withdrawal from circulation of such goods shall submit to the information monitoring system a notification of the withdrawal of goods from circulation containing the following information:<\/li>\n
                                                                                                  2. a) the taxpayer identification number of the exporter;<\/li>\n
                                                                                                  3. b) the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code, withdrawn from circulation;<\/li>\n
                                                                                                  4. c) the date of registration of the goods declaration;<\/li>\n
                                                                                                  5. d) the registration number of the goods declaration.<\/li>\n
                                                                                                  6. Upon the withdrawal of goods from circulation on the grounds of their export to member states of the Eurasian Economic Union within the framework of cross-border trade on the customs territory of the Eurasian Economic Union, the participant in the circulation of goods carrying out the withdrawal from circulation of such goods shall submit to the information monitoring system a notification of the withdrawal of goods from circulation containing the following information:<\/li>\n
                                                                                                  7. a) the taxpayer identification number of the participant in the circulation of goods selling (realizing) the goods;<\/li>\n
                                                                                                  8. b) the identification code, and\/or identification code of group packaging, and\/or identification code of a set, and\/or identification code of transport packaging, withdrawn from circulation.<\/li>\n
                                                                                                  9. In the event of the return of goods withdrawn from circulation on the basis of paragraphs 108 or 109 of these Rules, the participant in the circulation of goods shall, within 3 working days from the date of return of the goods, submit the corresponding information to the information monitoring system.<\/li>\n<\/ol>\n

                                                                                                    When returning goods with an undamaged means of identification, the goods shall not be relabeled, and the participant in the circulation of goods shall submit the following information to the information monitoring system:<\/p>\n

                                                                                                    the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                                    the identification code, and\/or identification code of group packaging, and\/or identification code of a set.<\/p>\n

                                                                                                    When returning goods with a damaged means of identification or without a means of identification (the possibility of identifying the goods is absent), the participant in the circulation of goods shall carry out their relabeling in accordance with paragraphs 73 and 118 of these Rules and submit the following information to the information monitoring system:<\/p>\n

                                                                                                    the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                                    a new identification code, and\/or a new identification code of group packaging, and\/or a new identification code of a set.<\/p>\n

                                                                                                      \n
                                                                                                    1. A participant in the circulation of goods selling (realizing) goods under a transaction, information about which constitutes a state secret, shall, no later than 3 working days from the date of shipment (transfer or acceptance) of the goods, submit the following information to the information monitoring system:<\/li>\n
                                                                                                    2. a) the taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;<\/li>\n
                                                                                                    3. b) the identification code, and\/or identification code of group packaging, and\/or identification code of a set, and\/or identification code of transport packaging, withdrawn from circulation;<\/li>\n
                                                                                                    4. c) the method of withdrawal of goods from circulation (sale of goods under a transaction, information about which constitutes a state secret);<\/li>\n
                                                                                                    5. d) the date of withdrawal of goods from circulation;<\/li>\n
                                                                                                    6. e) the identifier of the state contract for the state defense order, assigned in accordance with Article 6.1 of the Federal Law “On the State Defense Order”, on the basis of which such transaction is carried out (if available).<\/li>\n
                                                                                                    7. In the event of the return of goods withdrawn from circulation on the basis of paragraph 111 of these Rules, the participant in the circulation of goods shall, within 3 working days from the date of return of the goods, submit the corresponding information to the information monitoring system.<\/li>\n<\/ol>\n

                                                                                                      When returning goods with an undamaged means of identification, the goods shall not be relabeled, and the participant in the circulation of goods shall submit the following information to the information monitoring system:<\/p>\n

                                                                                                      the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                                      the identification code, and\/or identification code of group packaging, and\/or identification code of a set.<\/p>\n

                                                                                                      When returning goods with a damaged means of identification or without a means of identification (the possibility of identifying the goods is absent), the participant in the circulation of goods shall carry out their relabeling in accordance with paragraphs 73 and 118 of these Rules and submit the following information to the information monitoring system:<\/p>\n

                                                                                                      the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                                      a new identification code, and\/or a new identification code of group packaging, and\/or a new identification code of a set.<\/p>\n

                                                                                                        \n
                                                                                                      1. Participants in the circulation of goods, in the event of a decision to sell (sell) goods previously acquired under a transaction, information about which constitutes a state secret, under a transaction, information about which does not constitute a state secret, shall carry out the introduction of goods into circulation in the following procedure:<\/li>\n
                                                                                                      2. a) shall carry out the labeling of goods, if the goods have not been previously labeled, in the procedure provided for by these Rules;<\/li>\n
                                                                                                      3. b) prior to the display of the goods at the place of sale (sale), demonstration of their samples (with the exception of the submission of information about it when selling goods by remote method), shall form a notification of the introduction of goods into circulation and submit the following information to the information monitoring system:<\/li>\n<\/ol>\n

                                                                                                        the taxpayer identification number of the participant in the circulation of goods;<\/p>\n

                                                                                                        the identification code, and\/or identification code of group packaging, and\/or identification code of a set;<\/p>\n

                                                                                                        the identifier of the state contract for the state defense order, assigned in accordance with Article 6.1 of the Federal Law “On the State Defense Order”, on the basis of which the goods were withdrawn from circulation in the procedure established by paragraph 111 of these Rules.<\/p>\n

                                                                                                          \n
                                                                                                        1. Participants in the circulation of goods acquiring goods for use for purposes not related to their subsequent sale (sale), with the exception of participants in the circulation of goods acquiring goods not for retail sale, as well as for the purpose of use for carrying out activities in the field of healthcare and the provision of social-medical services, shall sign a notification confirming the transfer of ownership from the seller to the buyer, in the format of a universal transfer document. In the event that legal entities, branches of foreign legal entities, and individual entrepreneurs acquiring goods for use for purposes not related to their subsequent sale (sale) are not registered in the information monitoring system, the transmission to the information monitoring system of information on the withdrawal of goods from circulation may be carried out by the participant in the circulation of goods carrying out their sale (sale). Participants in the circulation of goods selling goods for use for purposes not related to their subsequent sale (sale), on the basis of the notification confirmed by the buyer confirming the transfer of ownership, shall, no later than 3 working days from the date of shipment (transfer or acceptance) of the goods, submit the following information to the information monitoring system:<\/li>\n
                                                                                                        2. a) the taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;<\/li>\n
                                                                                                        3. b) the taxpayer identification number of the legal entity, branch of a foreign legal entity, and individual entrepreneur acquiring goods for use for purposes not related to their subsequent sale (sale) (if such legal entities, branches of foreign legal entities, and individual entrepreneurs are not registered in the information monitoring system);<\/li>\n
                                                                                                        4. c) the identification code, and\/or identification code of group packaging, and\/or identification code of a set, and\/or identification code of transport packaging;<\/li>\n
                                                                                                        5. d) the method of withdrawal of goods from circulation (sale for the use of the goods by the buyer for purposes not related to their subsequent sale (sale));<\/li>\n
                                                                                                        6. e) the date of withdrawal of goods from circulation;<\/li>\n
                                                                                                        7. f) the price at which the goods are sold (including value-added tax) according to primary documents (in the case of sale (sale));<\/li>\n
                                                                                                        8. g) the name, number, and date of the document confirming the fact of sale (sale).<\/li>\n
                                                                                                        9. Participants in the circulation of goods returning to the seller goods withdrawn from circulation by sale for use for purposes not related to their subsequent sale (sale) shall form a notification in the format of a universal adjustment document signed with the enhanced electronic signature of both participants in the circulation of goods, confirming the transfer of ownership from the buyer to the seller.<\/li>\n<\/ol>\n

                                                                                                          When returning goods with an undamaged means of identification, the participant in the circulation of goods shall submit the following information to the information monitoring system:<\/p>\n

                                                                                                          the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                                          the identification code, and\/or identification code of group packaging, and\/or identification code of a set;<\/p>\n

                                                                                                          the details of the documents confirming the return of the goods.<\/p>\n

                                                                                                          When returning goods with a damaged means of identification or without a means of identification (the possibility of identifying the goods is absent), the participant in the circulation of goods shall carry out their relabeling in accordance with paragraphs 73 and 118 of these Rules and submit the following information to the information monitoring system:<\/p>\n

                                                                                                          the taxpayer identification number of the participant in the circulation of goods accepting the goods;<\/p>\n

                                                                                                          a new identification code, and\/or a new identification code of group packaging, and\/or a new identification code of a set;<\/p>\n

                                                                                                          the details of the documents confirming the return of the goods.<\/p>\n

                                                                                                            \n
                                                                                                          1. Participants in the circulation of goods that have made a decision to sell (sell) goods previously acquired by them for purposes not related to their subsequent sale (sale) shall, if necessary, carry out the relabeling of goods and, prior to the offering of these goods for sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples (with the exception of the submission of information about them when selling goods by remote method), submit to the information monitoring system a notification of the introduction into circulation containing the following information:<\/li>\n
                                                                                                          2. a) the taxpayer identification number of the participant in the circulation of goods;<\/li>\n
                                                                                                          3. b) the identification code, or identification code of group packaging, or identification code of a set, returned to circulation (if the means of identification is not damaged and not lost);<\/li>\n
                                                                                                          4. c) a new identification code, or identification code of group packaging, or identification code of a set (if necessary, if the means of identification is lost or damaged).<\/li>\n
                                                                                                          5. Participants in the circulation of goods, when carrying out the introduction into circulation of goods not sold as of the date of the introduction of mandatory labeling of goods, prior to the offering of these goods for sale (sale), shall submit to the information monitoring system a notification of the introduction into circulation containing the following information:<\/li>\n
                                                                                                          6. a) the taxpayer identification number of the participant in the circulation of goods;<\/li>\n
                                                                                                          7. b) the identification code, or identification code of group packaging, or identification code of a set;<\/li>\n
                                                                                                          8. c) the registration number and date of issuance (registration) of the permit document in the presence of requirements for the confirmation of conformity and\/or state registration of the goods;<\/li>\n
                                                                                                          9. d) the date and number of the registration certificate for the medical device.<\/li>\n
                                                                                                          10. n the event of the need to carry out relabeling in the case of damage or loss of the means of identification applied to the consumer packaging, or a label with the applied means of identification, the participant in the circulation of goods carrying out the trade in goods shall, prior to the offering of these goods for sale (sale), including prior to their display at the place of sale (sale), demonstration of their samples (with the exception of the submission of information about them when selling goods by remote method), submit the following information to the information monitoring system:<\/li>\n
                                                                                                          11. a) the identification code, or identification code of group packaging, or identification code of a set of the new means of identification;<\/li>\n
                                                                                                          12. b) the identification code, or identification code of group packaging, or identification code of a set of the damaged or lost means of identification (if available).<\/li>\n<\/ol>\n

                                                                                                             <\/p>\n

                                                                                                              \n
                                                                                                            1. Procedure for Making Amendments to Information Contained in the Information Monitoring System<\/strong><\/li>\n
                                                                                                            2. In the event of a change in the information provided for by Sections II, III, VII, and VIII of these Rules, the participant in the circulation of goods shall, within 3 working days from the date of their change, send a notification of the change of such information to the information monitoring system.<\/li>\n
                                                                                                            3. If, prior to the transmission to the information monitoring system of information on the acceptance of goods by participants in the circulation of goods, it is established that the information specified in the transfer documents requires correction or adjustment, then:<\/li>\n
                                                                                                            4. a) the participant in the circulation of goods that carried out the shipment (transfer) of the goods shall form a notification (in the format of a universal adjustment document or a corrected universal transfer document indicating the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging) on the clarification of information on the transfer (acceptance) of goods, signed with the enhanced electronic signature by both participants in the circulation of goods, and send it to the information monitoring system through the electronic document flow operator;<\/li>\n
                                                                                                            5. b) the operator of the information monitoring system, after receipt of the notification on the clarification of information on the transfer (acceptance) of goods signed with the enhanced electronic signatures by both participants in the circulation of goods, shall reflect in the register of means of identification of the information monitoring system the fact of the transfer of goods by one participant in the circulation of goods to another participant in the circulation of goods taking into account the information contained in such notification.<\/li>\n
                                                                                                            6. If, after the acceptance of the goods and the transmission of information about it to the information monitoring system, the participants in the circulation of goods have established that the information specified in the transfer documents requires correction or adjustment, then:<\/li>\n
                                                                                                            7. a) the participant in the circulation of goods that carried out the shipment (transfer) of the goods shall form a notification (in the format of a universal adjustment document or a corrected universal transfer document indicating the identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging) on the clarification of information on the transfer (acceptance) of goods, signed with the enhanced electronic signature by both participants in the circulation of goods, and send it to the information monitoring system through the electronic document flow operator;<\/li>\n
                                                                                                            8. b) the operator of the information monitoring system, after receipt of the notification on the clarification of information on the transfer (acceptance) of goods signed with the enhanced electronic signatures by both participants in the circulation of goods, shall reflect in the register of means of identification of the information monitoring system the fact of the transfer of goods by one participant in the circulation of goods to another participant in the circulation of goods taking into account the information contained in such notification.<\/li>\n
                                                                                                            9. To cancel or correct information previously submitted to the information monitoring system on the withdrawal of goods from circulation by a method that is not retail sale, the participant in the circulation of goods shall send to the information monitoring system a notification of the cancellation of the previously sent notification indicating its details and, if necessary, submit a new notification containing the information specified in paragraph 104 of these Rules.<\/li>\n
                                                                                                            10. It is not permitted to make amendments to the information monitoring system concerning information previously submitted by the participant in the circulation of goods to the information monitoring system on the introduction of goods into circulation, on the circulation of goods, and on their withdrawal from circulation, during the period of the conduct by the authorized federal executive body of an inspection of the activities of the participant in the circulation of goods that sent the notification of the change of information.<\/li>\n
                                                                                                            11. In the event of the need to make amendments to the information of the information monitoring system submitted in the procedure provided for by paragraph 33 of these Rules, the corrected acceptance document signed by both parties to the contract in the procurement information system in the procedure established by Part 14 of Article 94 of the Federal Law on the Contract System shall be sent to the information monitoring system in the procedure provided for by paragraph 33 of these Rules.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

                                                                                                                GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION of May 31, 2023 No. 894 ON APPROVAL OF THE RULES FOR LABELING CERTAIN TYPES OF MEDICAL DEVICES WITH IDENTIFICATION MEANS AND THE SPECIFICS OF IMPLEMENTATION OF THE STATE INFORMATION SYSTEM FOR MONITORING THE CIRCULATION OF GOODS SUBJECT TO MANDATORY LABELING WITH IDENTIFICATION MEANS IN RESPECT OF CERTAIN […]<\/p>\n","protected":false},"featured_media":2339,"template":"","categories":[25],"class_list":["post-2439","resources","type-resources","status-publish","has-post-thumbnail","hentry","category-regulatory-framework-en"],"_links":{"self":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources\/2439","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/types\/resources"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media\/2339"}],"wp:attachment":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media?parent=2439"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}