Resolution of the Government of the Russian Federation No. 894 of May 31, 2023

On Approval of the Rules for Marking Certain Types of Medical Devices with Identification Means and on the Specifics of Implementing the State Information System for Monitoring the Circulation of Goods Subject to Mandatory Marking with Identification Means in Respect of Certain Types of Medical Devices

(as amended by Resolutions of the Government of the Russian Federation
No. 392 of March 29, 2024,
No. 743 of May 31, 2024, No. 860 of June 26, 2024, No. 1630 of November 26, 2024,
No. 1409 of September 12, 2025)

The amendments introduced by Resolution of the Government of the Russian Federation No. 1409 of September 12, 2025 shall apply to legal relations arising from September 1, 2025 (with the exception of the seventh paragraph of Clause 28 of the Rules).

 

The Government of the Russian Federation RESOLVES:

1. Approve the annexed Rules for Marking Certain Types of Medical Devices with Identification Means.

2. Establish that participants in the circulation of certain types of medical devices in accordance with the Rules approved by this Resolution shall:

a) submit to the state information system for monitoring the circulation of goods subject to mandatory marking with identification means (hereinafter - the monitoring information system) an application for registration in the monitoring information system starting from September 1, 2023, but no later than 7 calendar days from the date when the participant in the circulation of certain types of medical devices has a need 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 has been established on the introduction into circulation, and (or) circulation, and (or) withdrawal from circulation of certain types of medical devices without marking with identification means (with the exception of participants in the circulation of certain types of medical devices falling under the provisions of Clauses 3 and 7 of Article 2 of the Federal Law "On the Use of Cash Register Equipment in Making Payments in the Russian Federation" (hereinafter - participants in the circulation of certain types of medical devices in remote or hard-to-reach areas).

At the same time, participants in the circulation of certain types of medical devices in remote or hard-to-reach areas shall register in the monitoring information system within 30 calendar days from the date when they have a need to carry out activities related to the introduction into circulation, and (or) circulation, and (or) withdrawal from circulation of certain types of medical devices;

b) ensure, no later than 15 calendar days from the date of registration in the monitoring information system, the readiness of their own software and hardware for information interaction with the monitoring information system and send to the operator of the monitoring information system an application for testing information interaction in electronic form;

c) for the purpose of carrying out work to ensure the readiness of their own software and hardware for information interaction with the monitoring information system and for passing information interaction testing in electronic form after registration in the monitoring information system, send in electronic form to the operator of the monitoring information system an application for providing remote access to the emission registration device located in the infrastructure of the monitoring information system;

d) undergo testing of information interaction of their own software and hardware and the monitoring information system in accordance with the procedure posted on the official website of the operator of the monitoring information system on the information and telecommunications network "Internet", in respect of operations related to the marking 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 calendar days from the date of readiness of their own software and hardware for information interaction with the monitoring information system and the submission of the application in accordance with subclause "b" of this clause.

3. Establish that:

a) participants in the circulation of certain types of medical devices holding a valid registration certificate for a medical device, who introduce certain types of medical devices into circulation, shall apply identification means to consumer packaging, including by affixing to such consumer packaging a label containing an identification means, of the specified certain types of medical devices and shall submit to the monitoring information system information on the application of identification means and the introduction into circulation of the specified certain types of medical devices in accordance with the Rules approved by this Resolution:

• in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles) (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 Russian Classification of Products by 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, medical device type codes in accordance with the nomenclature classification of medical devices 131980, 152690, 152700, 182750, 209360, 250220, 250230, 250250, 250260, 292620, 320560, 336330, 343610, 375930) from October 1, 2023;

• in respect of hearing aids, except for 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 Russian Classification of Products by 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, medical device type codes 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) from March 1, 2024.

At the same time, participants in the circulation of certain types of medical devices who introduce the specified certain types of medical devices into circulation shall, from the date of entry into force of this Resolution, have the right to apply identification means to consumer packaging, including by affixing to such consumer packaging a label containing an identification means, of the certain types of medical devices specified in the second and third paragraphs of this subclause, provided that information on the application of identification means and the introduction into circulation of the specified certain types of medical devices is submitted to the monitoring information system in accordance with the Rules approved by this Resolution, and shall also have the right to submit to the monitoring information 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 Clause 9 of this Resolution;

b) participants in the circulation of certain types of medical devices shall submit to the monitoring information 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, and 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.

At the same time, participants in the circulation of certain types of medical devices shall have the right to submit to the monitoring information 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;

c) participants in the circulation of certain types of medical devices in remote or hard-to-reach areas shall have the right to submit the information specified in Section VIII of the Rules approved by this Resolution within 30 calendar days:

• from the date of shipment (transfer or acceptance) of certain types of medical devices upon transfer (acceptance) of certain types of medical devices within the framework of transactions providing for the transfer of ownership of the specified goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements;

• from the date of withdrawal of certain types of medical devices from circulation in the event of withdrawal of certain types of medical devices from circulation;

• from the date of return of certain types of medical devices into circulation in the event of such return;

• from the date of amendment of the information provided for in Sections III, IV, VIII and IX of the Rules approved by this Resolution, in the event of amendment of such information;

d) participants in the circulation of certain types of medical devices shall mark certain types of medical devices imported (brought in) and placed under customs procedures of release for domestic consumption or reimportation, before offering such certain types of medical devices for sale (retail), and shall enter into the monitoring information system information on the marking of such certain types of medical devices with identification means in accordance with the Rules approved by this Resolution:

• in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles), acquired through September 30, 2023 (inclusive) and released by customs authorities starting from October 1, 2023 through October 31, 2023 (inclusive);

• in respect of hearing aids, except for parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, acquired through February 29, 2024 (inclusive) and released by customs authorities starting from March 1, 2024 through March 31, 2024 (inclusive);

e) participants in the circulation of certain types of medical devices who hold unsold certain types of medical devices on the territory of the Russian Federation shall have the right to sell such medical devices without marking with identification means until the expiry of their shelf life (with the exception of certain types of medical devices having a service life), or to mark such medical devices with identification means and submit information on the marking of certain types of medical devices with identification means to the monitoring information system in accordance with the Rules approved by this Resolution, through August 31, 2024 (inclusive):

• in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles), introduced into circulation through September 30, 2023 (inclusive) and not sold as of October 1, 2023;

• in respect of hearing aids, except for 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.

Participants in the circulation of certain types of medical devices having a service life, who hold such unsold certain types of medical devices on the territory of the Russian Federation, shall have the right to sell such medical devices without marking with identification means or to mark them with identification means and submit information on the marking of such certain types of medical devices with identification means to the monitoring information system in accordance with the Rules approved by this Resolution, through August 31, 2024 (inclusive):

• in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles), introduced into circulation through September 30, 2023 (inclusive) and not sold as of October 1, 2023;

• in respect of hearing aids, except for 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.

At the same time, participants in the circulation of certain types of medical devices having a service life, who acquired such medical devices for carrying out activities in the field of healthcare and providing social and medical services, shall have the right to store, transport and gratuitously transfer such medical devices provided for in the fifth and sixth paragraphs of this subclause without marking with identification means, and to sell (retail) such medical devices in accordance with the fourth paragraph of this clause.
(paragraph introduced by Resolution of the Government of the Russian Federation No. 392 of March 29, 2024)

In the cases specified in the first and (or) fourth paragraphs of this subclause, the participant in the circulation of certain types of medical devices shall register such medical devices in the subsystem of the national catalog of marked goods of the monitoring information system and indicate the information provided for in Clauses 37-41 of the Rules approved by this Resolution, shall ensure their marking, and shall also submit information on their marking with identification means to the monitoring information system in accordance with the Rules approved by this Resolution.

Payment for marking codes necessary for forming identification means of certain types of medical devices specified in the first and fourth paragraphs of this subclause shall be made in accordance with the Rules approved by this Resolution.

f) participants in the circulation of certain types of medical devices holding a valid registration certificate for a medical device, who introduce medical gloves into circulation, shall apply identification means to consumer packaging, including by affixing to such consumer packaging a label containing an identification means, of medical gloves and shall submit to the monitoring information system information on the application of identification means and the introduction into circulation of medical gloves (codes of the unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union 3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, codes of the Russian Classification of Products by Economic Activity 14.12.30.160, 22.19.60.111, 22.19.60.113, 22.19.60.119, 22.19.71.190, 22.29.10.120, 32.50.13.190, 32.50.50.190, medical device type codes in accordance with the nomenclature classification of medical devices 122540, 122560, 122610, 122630, 122640, 129800, 129900, 130220, 139310, 139350, 139360, 156530, 169840, 185700, 185720, 185830, 185850, 201590, 201600, 201610, 205280, 205290, 257300, 298450, 311720, 316120, 318420, 320790, 321530, 322780, 323740, 326340, 329770, 349230, 351490, 388560) in accordance with the Rules approved by this Resolution, from March 1, 2025;
(subclause "f" introduced by Resolution of the Government of the Russian Federation No. 860 of June 26, 2024)

g) participants in the circulation of certain types of medical devices shall submit to the monitoring information system in accordance with the Rules approved by this Resolution information on the withdrawal from circulation of certain types of medical devices specified in subclause "f" of this clause, from March 1, 2025, and information on the circulation of certain types of medical devices in accordance with the Rules approved by this Resolution, from March 1, 2026;

h) through March 31, 2025 (inclusive), participants in the circulation of certain types of medical devices shall mark medical gloves specified in subclause "f" of this clause, acquired through February 28, 2025 (inclusive), imported (brought in) and released by customs authorities from March 1, 2025 in accordance with the customs procedure of release for domestic consumption or reimportation, before offering such medical gloves for sale (retail), shall enter into the monitoring information system information on the marking of such medical gloves with identification means and shall introduce them into circulation in accordance with the Rules approved by this Resolution;
(subclause "h" introduced by Resolution of the Government of the Russian Federation No. 860 of June 26, 2024)

i) participants in the circulation of certain types of medical devices who, as of March 1, 2025, hold unsold medical gloves specified in subclause "f" of this clause, produced on the territory of the Russian Federation or imported into the territory of the Russian Federation through February 28, 2025 (inclusive), shall have the right through August 31, 2025 (inclusive) to sell such medical gloves without marking with identification means or to mark such medical gloves with identification means and submit information on marking with identification means to the monitoring information system in accordance with the Rules approved by this Resolution.

At the same time, participants in the circulation of certain types of medical devices who have acquired such medical gloves for the purpose of carrying out activities in the field of healthcare and providing social and medical services shall have the right to store, transport, and gratuitously transfer the medical gloves provided for in the first paragraph of this subclause without marking with identification means and to sell (retail) such medical gloves in accordance with the first paragraph of this subclause.

When carrying out marking with identification means of medical gloves in the case specified in the first paragraph of this subclause, the participant in the circulation of certain types of medical devices shall register such medical gloves in the subsystem of the national catalog of marked goods of the monitoring information system and indicate the information provided for in Clause 41(1) of the Rules approved by this Resolution, shall ensure their marking with identification means, and shall also submit information on their marking with identification means to the monitoring information system in accordance with the Rules approved by this Resolution.

Payment for marking codes necessary for generating identification means for medical gloves specified in the first paragraph of this subclause shall be made in accordance with the Rules approved by this Resolution.
(subclause "i" introduced by Resolution of the Government of the Russian Federation No. 860 of June 26, 2024)

4. Registration in the information system used for the purposes of ensuring the conduct of the experiment in accordance with Resolution of the Government of the Russian Federation No. 137 of February 9, 2022 "On Conducting on the Territory of the Russian Federation an Experiment on Marking Certain Types of Medical Devices with Identification Means" (hereinafter - 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 monitoring information system in accordance with subclause "a" of Clause 2 of this Resolution.

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 used for information support of the experiment does not meet the requirements of the Rules approved by this Resolution, participants in the circulation of certain types of medical devices shall submit the missing and (or) current information to the monitoring information system through September 30, 2023 (inclusive).

5. Establish that the operator of the monitoring information system shall ensure:

a) the organization of testing of information interaction of software and hardware of participants in the circulation of certain types of medical devices and the monitoring information 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 monitoring information system of a notification of readiness for information interaction with the monitoring information system;

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 monitoring information system, on the terms 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 monitoring information system of an application in electronic form for the provision of remote access to the emission registration device.

6. Establish that on the territory of the Russian Federation, the introduction into circulation of certain types of medical devices without applying identification means to consumer packaging, including by affixing to such consumer packaging a label containing an identification means, of certain types of medical devices and without submitting to the monitoring information system information on the marking of certain types of medical devices with identification means shall be permitted until the dates established by subclauses "a" and "f" of Clause 3 of this Resolution, from which the application of identification means to consumer packaging, including by affixing to such consumer packaging a label containing an identification means, of such certain types of medical devices and the submission of information to the monitoring information system become mandatory, with the exception of the cases specified in the first paragraph of subclause "d" and the first paragraph of subclause "i" of Clause 3 of this Resolution.

The circulation and withdrawal from circulation of unmarked certain types of medical devices produced in the Russian Federation or imported (brought in) into the Russian Federation in the case of import from the territory of the Eurasian Economic Union within the framework of cross-border trade or released by customs authorities upon their placement under customs procedures of release for domestic consumption or reimportation of unmarked certain types of medical devices (in the case of their production outside the Russian Federation) shall be permitted until the expiry of the shelf life of certain types of medical devices (with the exception of certain types of medical devices that have a service life, which are marked in accordance with the requirements of the fourth paragraph of subclause "d" and the first paragraph of subclause "i" of Clause 3 of this Resolution).

The release by customs authorities of imported (brought in) unmarked and placed under customs procedures of release for domestic consumption or reimportation of certain types of medical devices specified in subclauses "d" and "h" of Clause 3 of this Resolution shall be permitted:

• in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles) through October 31, 2023 (inclusive);

• in respect of hearing aids, except for parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, through March 31, 2024 (inclusive);

• in respect of medical gloves through March 31, 2025 (inclusive).
  (paragraph introduced by Resolution of the Government of the Russian Federation No. 860 of June 26, 2024)

7. 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 marking with identification means do not apply.

8. Establish that from October 1, 2023, the provision to a participant in the circulation of certain types of medical devices of marking codes necessary for forming identification means shall be carried out by the operator of the monitoring information system on a paid basis in accordance with the Rules approved by this Resolution.

9. From the date of entry into force of this Resolution, by decision of a participant in the circulation of certain types of medical devices, the provision to them of marking codes necessary for forming identification means may be carried out by the operator of the monitoring information system until the corresponding date established by Clause 3 of this Resolution, from which the application of identification means to consumer packaging of certain types of medical devices becomes mandatory. Such marking codes shall be provided by the operator of the monitoring information system on a gratuitous basis. At the same time, a participant in the circulation of certain types of medical devices who has received marking codes on a gratuitous basis shall ensure their conversion into identification means and submit to the monitoring information system a report on the application of identification means and information on the introduction into circulation of certain types of medical devices through September 30, 2023 (inclusive).

The service for the provision of a marking code in the case provided for by the first paragraph of this clause shall be deemed to have been rendered by the operator of the monitoring information system at the moment when the operator of the monitoring information system enters into the monitoring information system information on the introduction into circulation of certain types of medical devices, specified by the participant in the circulation of certain types of medical devices in the notification of the introduction into circulation of the relevant certain types of medical devices.

At the same time, the operator of the monitoring information system shall enter into the monitoring information system information on the introduction into circulation of certain types of medical devices after receiving from the participant in the circulation of certain types of medical devices a report on the application of identification means.

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

10. The application of identification means to consumer packaging of certain types of medical devices, including by affixing to such consumer packaging a label containing an identification means, shall not require amendments to the documents contained in the registration dossier for the medical device, in accordance with the procedure established by Clauses 37-51 of the Rules for State Registration of Medical Devices, approved by Resolution of the Government of the Russian Federation No. 1416 of December 27, 2012 "On Approval of the Rules for State Registration of Medical Devices."

11. This Resolution shall enter into force on September 1, 2023.

Chairman of the Government
of the Russian Federation
M. MISHUSTIN

 

Approved
by Resolution of the Government
of the Russian Federation
No. 894 of May 31, 2023

RULES
FOR MARKING CERTAIN TYPES OF MEDICAL DEVICES
WITH IDENTIFICATION MEANS

(as amended by Resolutions of the Government of the Russian Federation
No. 743 of May 31, 2024,
No. 860 of June 26, 2024, No. 1630 of November 26, 2024, No. 1409 of September 12, 2025)

I. General Provisions

1. These Rules establish the procedure for marking certain types of medical devices subject to mandatory marking with identification means, 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 marking with identification means (hereinafter - the monitoring information system), characteristics of the identification means, as well as the procedure for participants in the circulation of certain types of medical devices to submit information to the monitoring information system on the introduction into circulation, circulation and withdrawal from circulation of certain types of medical devices.

2. The concepts used in these Rules shall have the following meanings:

"aggregation" - 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 level of nesting, while retaining information on the relationship of 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 identification codes of each nested group packaging with the identification code of the transport packaging being created, or identification codes of each nested set with the identification code of the transport packaging being created, as well as on the relationship of identification codes of each nested transport packaging with the identification code of the transport packaging being created of a higher level of nesting, and by applying the appropriate identification means to the group packaging or set, or the identification code of transport packaging, for the purpose of ensuring traceability of the movement of goods along the supply chain without the need to open the created group and (or) transport packaging, or set and (or) transport packaging;

"aggregated customs code" - a unique sequence of characters for each separate aggregate of goods, representing a combination of identification codes, including identification codes of packaging that combines goods in the process of aggregation, generated by the operator of the monitoring information system for the purpose of identifying goods in accordance with these Rules, used by a participant in the circulation of goods when declaring goods to customs. At the same time, it is not permitted to combine into an aggregated customs code identification codes of goods, part of which has already been included in the identification code of group or transport packaging, or in another aggregated customs code;

"validation of an identification means" - assessment of the quality of converting a marking code into an identification means and its application for compliance of its structure with the requirements of these Rules;

"introduction of goods into circulation":

• in the case of production of goods on the territory of the Russian Federation (including cases of contract manufacturing), including cases of manufacturing 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 - the submission by a participant in the circulation of goods to the monitoring information system of a notification of the initial paid or gratuitous transfer of goods from the manufacturer to a new owner or to another person for the purpose of their 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 monitoring information 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 monitoring information system of information in accordance with Clause 77 of these Rules;

• in the case of production of goods outside the territory of the Russian Federation (with the exception of goods imported from member states of the Eurasian Economic Union) - 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 reimportation and the submission by the participant in the circulation of goods to the monitoring information system of a notification of the introduction of goods into circulation in accordance with Clause 78 of these Rules;

• in the case of production 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 - the import of goods into the Russian Federation by the participant in the circulation of goods and the submission by the participant in the circulation of goods to the monitoring information system of a notification of the introduction of goods into circulation with the submission to the monitoring information system of information in accordance with Clause 81 of these Rules;

• paid or gratuitous transfer to a new owner of goods acquired by participants in the circulation of goods in accordance with the established procedure upon the sale of property, based on the results of tenders within the framework of enforcement proceedings and bankruptcy procedures, sale of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation, and the submission by the participant in the circulation of goods to the monitoring information system of a notification of the introduction of goods into circulation in accordance with Clause 86 of these Rules;

• sale (retail) by the participant in the circulation of goods under a transaction that does not contain information constituting a state secret, of goods previously acquired under a transaction, information about which constitutes a state secret, and the submission by the participant in the circulation of goods to the monitoring information system of a notification of the introduction of goods into circulation in accordance with Clause 113 of these Rules;

• 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 own needs, production purposes, use within the framework of marketing promotions on the territory of the Russian Federation, use within the framework of charitable activities) (hereinafter - purposes not related to their subsequent sale (retail)), and the submission by the participant in the circulation of goods to the monitoring information system of a notification of the introduction of goods into circulation in accordance with Clause 116 of these Rules;

• sale (retail) of unsold remaining goods as of October 1, 2023 by the participant in the circulation of goods within the framework of transactions providing for the transfer of ownership of the specified goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements, and the submission by the participant in the circulation of goods to the monitoring information system of a notification of the introduction of goods into circulation in accordance with Clause 117 of these Rules;

"withdrawal of goods from circulation":

• sale (retail) or other transfer of marked goods to an individual for personal consumption on the basis of contracts providing for the transfer of ownership of goods, including retail sale, gratuitous transfer, assignment of rights, compensation or novation;

• sale (retail) of goods to legal entities, accredited branches of foreign legal entities in the Russian Federation (hereinafter - branches of foreign legal entities) and individuals registered as individual entrepreneurs (hereinafter - individual entrepreneur) for purposes not related to the subsequent sale (retail) of such goods;

• seizure (confiscation), write-off (disposal) (including in connection with information letters from the Federal Service for Surveillance in Healthcare on the identification of substandard, unregistered, counterfeit medical devices in circulation), destruction or irretrievable loss of goods;

• sale (retail) of marked goods outside the Russian Federation;

• sale (retail) of goods under a transaction, information about which constitutes a state secret;

• sale (retail) of goods by selling them by samples or remotely when shipping goods from a storage warehouse for delivery to the consumer;

• use of goods for purposes not related to their subsequent sale (retail);

• offering goods for sale (retail) through a vending machine or parcel terminal when shipping goods from a storage warehouse for delivery to the vending machine or parcel terminal;

• supply of marked goods within the framework of execution of contracts concluded in accordance with the Federal Law "On the Contract System in the Sphere of Procurement of Goods, Works, Services for State and Municipal Needs" (hereinafter - the Federal Law on the Contract System), with the exception of the supply of marked goods to participants in the circulation of goods who acquire such goods not for retail sale, but for carrying out activities in the field of healthcare and the provision of social and medical services;

"group packaging" - packaging marked with an identification means, combining a certain number of goods in consumer packaging with one product code, marked with identification means, which may be unpacked or sold to the consumer unchanged;

"importer" - a legal entity, branch of a foreign legal entity or individual entrepreneur importing goods into the Russian Federation, with the exception of cases of transit movement of such goods through the territory of the Russian Federation;

"individual serial number" - a sequence of characters that uniquely identifies a unit of goods (goods in consumer packaging, or group packaging, or set) on the basis of the product code;

"electronic interaction interface" - a set of means and rules ensuring the interaction of software and hardware of participants in the circulation of goods and the monitoring information system;

"corrected universal transfer document" - an electronic primary document on shipment of goods (on performance of work, on provision of services), on 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;

"identification code of group packaging" - a sequence of characters representing a unique number of group packaging, generated for the purpose of identifying goods in group packaging in accordance with the requirements provided for by Section V of these Rules;

"identification code of a set" - a sequence of characters representing a unique number of a set instance, generated for the purpose of identifying a set in accordance with Section V of these Rules;

"identification code of transport packaging" - a sequence of characters representing a unique number of transport packaging, generated in accordance with Section V of these Rules;

"contract manufacturing" - the production of goods by a third-party manufacturer of goods on the basis of an agreement with a participant in the circulation of goods using a trademark registered for such participant in the circulation of goods (trademark holder), or a trademark of a third party in respect of which the participant in the circulation of goods has the right of use;

"marked goods" - goods to whose consumer packaging identification means have been applied, including by affixing to such consumer packaging a label containing an identification means, in compliance with the requirements of these Rules, and reliable information on which (including information on the identification means applied to the consumer packaging, including by affixing to such consumer packaging a label containing an identification means, of the said goods) is contained in the monitoring information system;

"marking of goods" - the application in accordance with these Rules of identification means to consumer packaging of goods, including by affixing to such consumer packaging a label containing an identification means;

"set" - a set of goods with different product codes in consumer packaging, each of which is subject to mandatory marking with identification means, has an identification code, formed by participants in the circulation of goods at any stage, having an identification code of the set and subject to sale (retail) to the consumer;

"operator of the monitoring information system" - a legal entity registered on the territory of the Russian Federation, carrying out the creation, development, modernization and operation of the monitoring information system, ensuring its uninterrupted functioning, as well as the receipt, storage and processing of information;

"operator of the national marking information system" - the competent (authorized) bodies of the member states of the Eurasian Economic Union, which include executive authorities of the member states of the Eurasian Economic Union authorized in accordance with the legislation of the member state of the Eurasian Economic Union to ensure control over the circulation of goods, and (or) interdepartmental coordination of the activities of executive authorities of the member states of the Eurasian Economic Union for control over the circulation of goods, and (or) the functioning of the national component of the information system for marking goods with identification means, and (or) coordination of activities to ensure its functioning, as well as private operators authorized by such competent (authorized) bodies of the member states of the Eurasian Economic Union;

"re-marking" - the repeated application of identification means to consumer packaging, including by affixing to such consumer packaging a label containing an identification means, in connection with the loss or damage of previously applied identification means;

"subsystem of the national catalog of marked goods" - a subsystem of the monitoring information system used for cataloging and storing information about marked goods and being the single source of the product code;

"consumer packaging" - packaging intended for sale or primary packaging of goods sold to the end consumer;

"offering goods for sale (retail)" - the provision by the seller to the buyer of goods (samples of goods) for direct inspection, including by displaying them at the place of sale (retail). The provision by the seller to the buyer of a description of the goods in distance selling, which is contained in catalogues, prospectuses, booklets or presented in photographs, or using postal networks, telecommunication networks, including the information and telecommunications network "Internet" (hereinafter - the "Internet" network), as well as communication networks for broadcasting television channels and (or) radio channels, or by other means that exclude the possibility of direct inspection by the buyer of the goods or a sample of the goods when concluding a purchase and sale agreement, shall not be considered an offer for sale (retail);

"manufacturer" - a legal entity, or a branch of a foreign legal entity, or an individual entrepreneur who are tax residents of the Russian Federation, carrying out the production and sale (retail) of goods on the territory of the Russian Federation;

"data transfer protocol" - a formalized set of requirements for the structure of information packets and the algorithm for exchanging information packets between devices of the data transmission network;

"service provider" - a legal entity that, on behalf of a participant in the circulation of goods, converts a marking code into an identification means and (or) applies an identification means to consumer packaging, and (or) group packaging, and (or) a set, and (or) a label;

"identification means" - a marking code in machine-readable form, presented 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;

"status of identification code, identification code of group packaging, identification code of a set, identification code of transport packaging, aggregated customs code" - the state of the identification code, identification code of group packaging, identification code of a set, identification code of transport packaging, aggregated customs code determined in the monitoring information system, which changes within the processes provided for by these Rules, the possible statuses of which are provided for in Clause 5 of these Rules;

"third-party manufacturer of goods" - a legal entity, or a branch of a foreign legal entity, or an individual entrepreneur who are tax residents of the Russian Federation, carrying out the production and transfer of goods to the manufacturer within the framework of contract manufacturing;

"goods" - certain types of medical devices holding a valid registration certificate, in respect of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles), hearing aids, except for parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence, medical gloves, corresponding to codes of the unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (hereinafter - 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 Russian Classification of Products by 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 medical device type codes 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;

"transport packaging" - transport packaging that combines goods in consumer packaging, and (or) group packaging, and (or) sets, used for 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 smaller size (volume). At the same time, packaging that combines only goods in consumer packaging, and (or) group packaging, and (or) sets shall be recognized as first-level transport packaging, and subsequent transport packaging of different degrees of nesting, starting with packaging containing exclusively first-level transport packaging, shall be recognized as transport packaging of the subsequent (second, third, etc.) level;

"notification of introduction of goods into circulation" - an electronic document generated by a participant in the circulation of goods in the monitoring information system and containing the information specified in Clauses 77, 78, 81, 86, 113, 116 and 117 of these Rules;

"universal adjustment document" - an electronic document confirming the buyer's consent (fact of notification) to a change in the cost of shipped goods (work performed, services rendered), 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 levies;

"universal transfer document" - an electronic primary document on shipment of goods (on performance of work, on provision of services), on 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 levies;

"participants in the circulation of goods" - legal entities and individual entrepreneurs, as well as branches of foreign legal entities that are 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:

• acquiring goods for use for purposes not related to their subsequent sale (retail) (except for cases of import of goods by importers into the Russian Federation, as well as acquisition of goods for use in carrying out activities in the field of healthcare and the provision of social and medical services);

• providing, when selling goods by samples or remotely, postal services in respect of postal items with cash on delivery, or goods delivery services to consumers, or acting as payment agents who do not carry out the circulation of marked goods (this 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 one unit of goods, a set of services for warehouse storage, picking and (or) packaging, including with the involvement of third parties);

• 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);

"label" - an information carrier intended for applying information about the goods and (or) identification means, attached directly to consumer packaging, and (or) group packaging, and (or) set packaging, including by means of gluing.

Other concepts used in these Rules shall apply in the meanings defined by the legislation of the Russian Federation in the field of mandatory marking of goods with identification means.

3. The effect of these Rules, in addition to the cases provided for in Clause 3 of the Rules for Marking Goods Subject to Mandatory Marking with Identification Means, approved by Resolution of the Government of the Russian Federation No. 515 of April 26, 2019 "On the System of Marking Goods with Identification Means and Traceability of Goods Movement" (hereinafter - the Rules for Marking Goods), shall not extend to:

a) goods placed under customs procedures for the purpose of their export outside the customs territory of the Eurasian Economic Union;

b) goods imported into the Russian Federation or produced on the territory of the Russian Federation by participants in the circulation of goods as advertising or marketing samples not intended for sale (retail);

c) goods acquired under a transaction, information about which constitutes a state secret, during their transportation by a participant in such a transaction through the territory of the Russian Federation;

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."

4. The operator of the monitoring information system shall have the right to provide marking codes to operators of national marking information systems. Marking codes must be used by participants in the circulation of goods of the member states of the Eurasian Economic Union for marking with identification means goods imported into the Russian Federation.

The receipt of marking codes by operators of national marking information systems shall be carried out through the exchange of information with the operator of the monitoring information system in accordance with the procedure established by Decision of the Board of the Eurasian Economic Commission No. 100 of July 13, 2022.

For the purpose of obtaining marking codes, operators of national marking information systems shall conclude with the operator of the monitoring information system an agreement on the provision of services for the provision of marking codes.

5. In the monitoring information system, the following statuses of the identification code, identification code of group packaging, identification code of a set, identification code of transport packaging, and aggregated customs code are possible:

a) for the identification code, identification code of group packaging, identification code of a set:

• "issued" - the identification code as part of the marking code has been provided by the operator of the monitoring information system to a participant in the circulation of goods for the purpose of marking goods with identification means; the corresponding goods have not been introduced into circulation;

• "in circulation" - the identification code as part of the marking code has been provided by the operator of the monitoring information system to a participant in the circulation of goods; the corresponding goods are marked with identification means, introduced into circulation and are in circulation. For the identification code of goods produced 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 reimportation, and the submission by the participant in the circulation of goods to the monitoring information system of information in accordance with Clause 78 of these Rules;

• "withdrawn" - the identification code as part of the marking code has been withdrawn from circulation; the corresponding goods have been withdrawn from circulation;

b) for the identification code of transport packaging and aggregated customs code:

• "formed" - assigned automatically after the submission of information by a participant in the circulation of goods with the described composition of the identification code of transport packaging, aggregated customs code;

• "unformed" - assigned automatically in the process of complete unformation of the composition of transport packaging, aggregated customs code.

6. Marking of goods with identification means shall be carried out taking into account the requirements for the safety of goods.

II. Requirements for Participants in the Circulation of Goods, Procedure for Their Registration in the Monitoring Information System. Requirements for Service Providers

7. Participants in the circulation of goods must:

a) hold a qualified certificate of the key for verifying an electronic signature, corresponding to the electronic signature key, allowing the creation of a strengthened qualified electronic signature (hereinafter - strengthened electronic signature);

b) have a software and hardware complex capable of generating and signing electronic documents with a strengthened electronic signature, as well as exchanging necessary electronic documents with the monitoring information system, including through a personal account;

c) have remote access to the emission registration device located in the infrastructure of the monitoring information system (for participants in the circulation of goods carrying out marking and (or) re-marking of goods in accordance with the requirements of these Rules);

d) have concluded an agreement with an electronic document management operator (for participants in the circulation of goods transferring the information provided for by these Rules in accordance with the procedure established by Clause 23 of these Rules).

8. A participant in the circulation of goods carrying out trade using cash register equipment (including commission trade in 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 in Clause 7 of these Rules, must have:

a) software and (or) technical means of identification means recognition interfaced with the cash register equipment;

b) concluded with an organization established in accordance with the legislation of the Russian Federation, located on the territory of the Russian Federation, which has received permission to process fiscal data in accordance with the legislation of the Russian Federation on the use of cash register equipment (hereinafter - operator of fiscal data), an agreement for processing and transferring, on behalf of the participant in the circulation of goods, to the monitoring information system information on the circulation of goods in the event that the transaction is carried out between participants in the circulation of goods registered in the monitoring information system, or on the withdrawal from circulation of marked goods using cash register equipment for each sold unit of goods (except for the transfer of information on the withdrawal from circulation of marked goods in cases where cash register equipment is used in a mode that does not provide for the mandatory transfer of fiscal documents to tax authorities in electronic form through the operator of fiscal data).

9. The provision of remote access to the emission registration device located in the infrastructure of the monitoring information system shall be carried out by the operator of the monitoring information system on a gratuitous basis.

10. Service providers must have a set of printing equipment with sufficient capacity to convert and apply identification means on behalf of a participant in the circulation of goods, but not lower than regularly placed orders for the production of consumer packaging and labels from the participant in the circulation of goods, and ensuring the application of marking 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 technology. Automatic identification and data capture techniques. Bar code symbol print quality test specification. Two-dimensional symbols," approved by order of the Federal Agency for Technical Regulation and Metrology No. 357-st of September 18, 2012 and put into effect from July 1, 2013 (hereinafter - the national standard of the Russian Federation GOST R ISO/IEC 15415-2012).

11. Service providers shall ensure compliance with such rules for handling marking codes as:

a) storage of marking codes received from participants in the circulation of goods using the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system;

b) use of the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system for delivering marking codes from the participant in the circulation of goods to the service provider;

c) delivery of information on the application and (or) validation of the identification means to the participant in the circulation of goods using the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system;

d) use of the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system, in the event that it becomes necessary to transfer marking codes received from the participant in the circulation of goods to another service provider;

e) hardware (using machine vision means) validation of the identification means;

f) deletion of the verification code after validation of the identification means and generation of information on the application and validation of the identification means;

g) selection of marking codes from the storage of the software and hardware complex for distribution of marking codes with separate operational storage (during the production cycle of converting marking codes into identification means) of marking codes and information on the application and validation of identification means of different participants in the circulation of goods;

h) ensuring the impossibility of re-applying marking codes after their conversion and validation of the identification means;

i) sending to the participant in the circulation of goods information on the validation of identification means.

12. The service provider shall ensure:

a) conversion of marking codes into identification means (print management);

b) generation of information on the application and (or) validation of the identification means and their submission to the participant in the circulation of goods;

c) compliance with quality standards for printing identification means and validation of the identification means before transferring the consumer packaging, or group packaging, or set, or label with the applied identification means to the participant in the circulation of goods.

13. The provision to the service provider of the software and hardware complex for distribution of marking codes shall be carried out by the operator of the monitoring information system on a gratuitous basis.

14. For the purpose of obtaining the specified software and hardware complex for distribution of marking codes, service providers shall conclude agreements with the operator of the monitoring information system.

15. Registration of a participant in the circulation of goods in the monitoring information system shall be carried out on the basis of an application of the participant in the circulation of goods sent to the monitoring information system and signed with a strengthened electronic signature of the participant in the circulation of goods.

16. In addition to the information provided for in Clause 14 of the Rules for Marking Goods, the application for registration in the monitoring information system must contain:

a) the surname, first name and patronymic (if any) of the person entitled to act on behalf of the participant in the circulation of goods without a power of attorney;

b) the telephone number and email address of the participant in the circulation of goods to which notifications from the monitoring information system will be sent.

17. An applicant - a branch of a foreign legal entity, in addition to the grounds provided for in Clause 17 of the Rules for Marking Goods (excluding the ground provided for in subclause "d" of the said clause), shall be refused registration in the monitoring information system in the event of a discrepancy between the information regarding the applicant specified in the registration application and the information specified in the state register of accredited branches and representative offices of foreign legal entities, as well as in the event that there is no record of the applicant in the said register or there is a record of the termination of its accreditation.

18. Upon application of a person entitled to act on behalf of the participant in the circulation of goods without a power of attorney, information may be entered into the monitoring information system about persons authorized to sign certain documents on behalf of the participant in the circulation of goods (hereinafter - authorized person). Such application must contain the following information:

a) certificate of the key for verifying the strengthened electronic signature of the authorized person;

b) surname, first name and patronymic (if any) of the authorized person;

c) types of documents submitted to the monitoring information system that the authorized person is entitled to sign;

d) availability of a document confirming the authority of the authorized person;

e) validity period of the document confirming the authority of the authorized person.

19. In the event of termination of the authority of an authorized person, the person entitled to act on behalf of the participant in the circulation of goods without a power of attorney shall enter into the monitoring information system information on the date of termination of the document confirming the authority of the authorized person.

20. In addition to the grounds for refusal provided for in Clause 29 of these Rules, entry of information on an authorized person into the monitoring information system shall also be refused if the authorized person is already registered in the monitoring information system as an authorized person of this participant in the circulation of goods.

21. A participant in the circulation of goods previously registered in the monitoring information system as a participant in the circulation of other goods subject to mandatory marking with identification means, for registration as a participant in the circulation of goods, shall send to the monitoring information system a corresponding notification containing the following information:

a) taxpayer identification number of the participant in the circulation of goods;

b) name of the product group "Medical Devices";

c) type of participant in the circulation of goods (one participant in the circulation of goods may belong to several types).

III. Procedure for Information Exchange of Participants in the Circulation of Goods with the Monitoring Information System

22. The submission of information by participants in the circulation of goods to the monitoring information system shall be carried out using standard data transfer protocols and electronic interaction interfaces developed by the operator of the monitoring information system by exchanging electronic documents (application, notification, receipt, etc.), the format of which is determined by the operator of the monitoring information system and posted on the official website of the operator of the monitoring information system on the Internet.

23. The obligation to submit to the monitoring information system the information provided for by these Rules, transmitted as part of universal transfer documents, corrected universal transfer documents, universal adjustment documents, shall be fulfilled by the participant in the circulation of goods through the operator of electronic document management on the basis of an agreement concluded between them, which must provide for the following:

a) the transfer of universal transfer documents, corrected universal transfer documents, universal adjustment documents signed by both parties to the transaction from the participant in the circulation of goods by the operator of electronic document management to the monitoring information system shall be carried out in real time;

b) the transfer by the operator of electronic document management to the participant in the circulation of goods of notifications (receipts) of the operator of the monitoring information system specified in Clause 30 of these Rules shall be carried out in real time;

c) the date of fulfillment by the participant in the circulation of goods of the obligation to submit information to the monitoring information system shall be deemed the date of receipt of the universal transfer document, corrected universal transfer document, universal adjustment document by the operator of the monitoring information system;

d) responsibility for the correctness of the information contained in universal transfer documents, corrected universal transfer documents and universal adjustment documents shall be borne by the participant in the circulation of goods, and responsibility for the immutability and timeliness of transfer to the monitoring information system of universal transfer documents, corrected universal transfer documents, universal adjustment documents submitted by the participant in the circulation of goods shall be borne by the operator of electronic document management.

24. The submission by a participant in the circulation of goods of information on group packaging or a set shall be equivalent to the submission of information on the consumer packaging contained in such group packaging or in such set, respectively, on the basis of data from the monitoring information system. The participant in the circulation of goods shall independently carry out the aggregation of marked goods in consumer packaging into group packaging and (or) a set and submit to the monitoring information system information on the identification codes included in the identification code of the group packaging and (or) the identification code of the set, respectively. It is not permitted to aggregate marked goods in consumer packaging into group packaging and (or) a set if they have already been included in another group packaging and (or) set.

25. The submission by a participant in the circulation of goods of information on transport packaging shall be equivalent to the submission of information on all (consumer, group, transport) packaging or sets contained in such transport packaging on the basis of data from the monitoring information system. The participant in the circulation of goods shall independently carry out the aggregation of marked goods in consumer packaging, and (or) group packaging, and (or) transport packaging, and (or) sets into transport packaging and submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging included in the identification code of the transport packaging. It is not permitted to aggregate marked goods in consumer packaging, and (or) group packaging, and (or) transport packaging, and (or) sets into transport packaging if they have already been included in other transport packaging.

26. The submission by a participant in the circulation of goods of information on the inclusion of consumer packaging in group packaging or a set, or on the inclusion in transport packaging of consumer packaging, or group packaging, or transport packaging, or sets which, according to the data of the monitoring information system, were previously included in another group packaging, or set, or transport packaging, shall be the basis for reflecting in the monitoring information system the fact of the unformation of previously created group packaging, or sets, and (or) transport packaging that included such packaging.

27. The submission by a participant in the circulation of goods of information on aggregated customs codes shall be equivalent to the submission of information on identification codes, identification codes of sets, identification codes of group packaging of goods imported (brought in) into the customs territory of the Eurasian Economic Union contained in the aggregated customs code on the basis of data from the monitoring information system.

28. From October 1, 2023, participants in the circulation of goods shall submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging when introducing into circulation disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), orthopedic footwear and corrective insole elements for orthopedic footwear (including insoles, partial insoles).

From March 1, 2024, participants in the circulation of goods shall submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging when introducing into circulation hearing aids, except for parts and accessories, coronary stents, computed tomography scanners, sanitary and hygienic products used for incontinence.

At the same time, information within the framework of transactions providing for the transfer of ownership of these goods (with the exception of sanitary and hygienic products used for incontinence), as well as within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements shall not be transmitted to the monitoring information system through August 31, 2025 (inclusive). In respect of sanitary and hygienic products used for incontinence, information within the framework of transactions providing for the transfer of ownership of these goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements shall not be transmitted to the monitoring information system through February 28, 2026 (inclusive).

From September 1, 2024, participants in the circulation of goods, in addition to the information provided for in the first and second paragraphs of this clause, shall submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets when they are withdrawn from circulation.

From March 1, 2025, participants in the circulation of goods shall submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging when introducing into circulation and when withdrawing from circulation medical gloves. In respect of medical gloves, information within the framework of transactions providing for the transfer of ownership of these goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements shall not be transmitted to the monitoring information system through February 28, 2026 (inclusive).

From September 1, 2025, participants in the circulation of goods shall submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging in respect of goods introduced into circulation from September 1, 2025, both when introducing goods into circulation and withdrawing goods from circulation, as well as within the framework of transactions providing for the transfer of ownership of these goods, and within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements.

From March 1, 2026, participants in the circulation of goods in respect of sanitary and hygienic products used for incontinence and medical gloves introduced into circulation from March 1, 2026, shall submit to the monitoring information system information on identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging both when introducing goods into circulation and withdrawing goods from circulation, as well as within the framework of transactions providing for the transfer of ownership of such goods, and within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements.
(paragraph introduced by Resolution of the Government of the Russian Federation No. 1409 of September 12, 2025)

29. The operator of the monitoring information system shall refuse to accept documents (applications, notifications) or to enter into the monitoring information system information submitted by participants in the circulation of goods to the monitoring information system if any of the following grounds exist:

a) the submitted documents have been prepared in violation of the established format, contain incorrect information, or do not contain the mandatory information provided for in Sections II, VIII and IX of these Rules;

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 in the circulation of goods, or who does not have the right to sign documents of that type;

c) there is a record in the Unified State Register of Legal Entities regarding the participant in the circulation of goods on the termination of the activity of the legal entity, or a record in the Unified State Register of Individual Entrepreneurs on the termination by an individual of activity as an individual entrepreneur, or a record in the state register of accredited branches and representative offices of foreign legal entities on the termination of accreditation of a branch of a foreign legal entity;

d) failure to receive into the monitoring information system the information specified in Clause 83 of these Rules, requested from the Unified Automated Information System of Customs Authorities or from customs authorities in another manner provided for by the agreement on information interaction.

30. A participant in the circulation of goods shall be notified of the receipt of submitted electronic documents, or of the entry of information into the monitoring information system, or of the refusal to accept electronic documents, or of the refusal to enter information into the monitoring information system, by sending to them a notification (receipt) of the receipt of electronic documents, or of the entry of information into the monitoring information system, or of the refusal to accept electronic documents, or of the refusal to enter information into the monitoring information system, containing the following information:

a) registration number of the document received from the participant in the circulation of goods;

b) notification (receipt) number;

c) date of the notification (receipt);

d) identification codes, identification codes of group packaging, identification codes of sets, identification codes of transport packaging, aggregated customs codes (in the case of production of goods outside the territory of the Russian Federation and imported (brought in) into the customs territory of the Eurasian Economic Union) and their status (change of status) in the monitoring information system (if the document submitted by the participant in the circulation of goods contains information on transactions performed with goods);

e) a message on the receipt or entry of documents (information) into the monitoring information system, or on the reasons for refusal to enter them.

30(1). Electronic documents automatically generated and submitted by participants in the circulation of goods to the monitoring information system in accordance with the procedure provided for in Clause 22 of these Rules (with the exception of the application for registration of a participant in the circulation of goods, the application for testing information interaction, and the application for access to the emission registration device) may be signed with the strengthened 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 means used for the automatic creation of electronic signatures.
(Clause 30(1) introduced by Resolution of the Government of the Russian Federation No. 743 of May 31, 2024)

31. The notifications (receipts) specified in Clause 30 of these Rules shall be sent by the operator of the monitoring information system to the operator of electronic document management, or to the operator of fiscal data, or to the participant in the circulation of goods using electronic interaction interfaces through the personal account in the monitoring information system or by email within one calendar day from the date of submission by the participant in the circulation of goods of documents or information to the monitoring information system.

32. The fact of fulfillment by a participant in the circulation of goods of the obligation to submit electronic documents (information) to the monitoring information system shall be confirmed by a notification (receipt) of the entry of electronic documents (information) into the monitoring information system.

The date of submission by a participant in the circulation of goods of electronic documents (information) to the monitoring information system shall be deemed the date recorded in the notification (receipt) of acceptance of electronic documents (receipt of information).

The said notifications (receipts) shall be automatically generated, signed with the strengthened electronic signature of the operator of the monitoring information system using electronic signature means used for the automatic creation of electronic signatures, and sent to the participant in the circulation of goods through the monitoring information system in the form of an electronic document upon placement of the transmitted documents (information) in the monitoring information system.

33. The obligation to submit to the monitoring information system the information provided for by these Rules upon the supply of marked goods within the framework of the execution of 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 by Part 13 of Article 94 of the Federal Law on the Contract System (hereinafter - acceptance documents) to the unified information system in the sphere of procurement (hereinafter - the procurement information system).

The information interaction of the monitoring information system and the procurement information system shall be carried out in accordance with the agreement on information interaction. Notifications (receipts) of the operator of the monitoring information system specified in Clause 30 of these Rules, in the event of transfer of information in accordance with this clause, shall be transmitted by the operator of the monitoring information system to participants in the circulation of goods through the federal executive body exercising the functions of creating, developing, maintaining and servicing the procurement information system (hereinafter - the operator of the procurement information system).

The operator of the procurement information system shall ensure:

• the transfer of acceptance documents signed by both parties to the contract to the monitoring information system within 2 hours from the moment of signing by the recipient of the goods in the procurement information system of the acceptance document and its placement in the procurement information system, as well as informing the participant in the circulation of goods about the results of the transfer;

• the transfer to participants in the circulation of goods of notifications (receipts) of the operator of the monitoring information system specified in Clause 30 of these Rules, within 2 hours from the moment of signing by the recipient of the goods in the procurement information system of the acceptance document and its placement in the procurement information system, provided that such notifications (receipts) are received from the operator of the monitoring information system.

In the event of transfer of an acceptance document through the operator of the procurement information system:

• the date of fulfillment by the participant in the circulation of goods of the obligation to submit information to the monitoring information system shall be deemed the date of receipt of the acceptance document by the operator of the monitoring information system;

• responsibility for the correctness of the information contained in acceptance documents and corrected acceptance documents shall be borne by the participant in the circulation of goods, and responsibility for the immutability and timeliness of transfer to the monitoring information system of acceptance documents and corrected acceptance documents submitted by the participant in the circulation of goods shall be borne by the operator of the procurement information system.

34. The obligation to submit to the monitoring information system the information provided for by these Rules, in the case of centralized supply and withdrawal from circulation of marked goods within the framework of execution of 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 activities in the field of healthcare and the provision of social and medical services, who is the actual consignee of such goods, in accordance with the procedure provided for in Clause 23 of these Rules.

35. Participants in the circulation of goods shall submit information to the monitoring information 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.

The operator of the monitoring information system shall ensure the placement of documents and information submitted by a participant in the circulation of goods in the monitoring information system within one calendar day from the date of receipt of such documents and information, with the mandatory sending of a notification (receipt) of the entry of changes into the monitoring information 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 the entry of such changes affects their interests.

IV. Registration of Goods in the Monitoring Information System

36. Registration of goods shall be carried out by participants in the circulation of goods in the subsystem of the national catalog of marked goods on the basis of a submitted application for registration of goods:

a) in the case of production of goods on the territory of the Russian Federation - by manufacturers (including cases of contract manufacturing);

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 the framework of cross-border trade on the customs territory of the Eurasian Economic Union - by the importer;

c) in the case of sale (retail) of goods previously acquired under a transaction, information about which constitutes a state secret - by the participant in the circulation of goods who acquired the goods and decided on their further sale (retail) under a transaction, information about which does not constitute a state secret;

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 - by the participant in the circulation of goods who is a retail trade organization;

e) in the case of return into circulation of goods acquired by participants in the circulation of goods for purposes not related to their subsequent sale (retail) - by the participant in the circulation of goods carrying out the return of the goods into circulation;

f) in the case of acquisition for the purpose of further sale (retail) of goods based on the results of tenders within the framework of enforcement proceedings and bankruptcy procedures, sale of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation - by the participant in the circulation of goods who acquired such goods;

g) in the case of the presence of goods not marked with identification means that are in circulation on the date of commencement of mandatory marking of goods (remaining goods) - by the participant in the circulation of goods carrying out the circulation of such goods;

h) in the case of formation of sets - by the participant in the circulation of goods before the sale (retail) of such sets to third parties, including before their display at the place of sale (retail) or demonstration of their samples.

37. For registration of disinfectants - air purifiers (including equipment, bactericidal units and recirculators used for filtering and purifying air in rooms), hearing aids and computed tomography scanners in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information about the goods being registered:

a) taxpayer identification number of the applicant;

b) product code (if available);

c) full name of the goods;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature;

f) country of production code in accordance with the Russian Classification of Countries of the World;

g) type of goods;

h) manufacturer's model (article number);

i) registration certificate number for the medical device and name of the medical device model;

j) number and date of the declaration of conformity (if available);

k) shelf life or service life, number of months (for service life).

38. For registration of orthopedic footwear in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information about the goods being registered:

a) taxpayer identification number of the applicant;

b) product code (if available);

c) full name of the goods;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature;

f) country of production code in accordance with the Russian Classification of Countries of the World;

g) category of goods;

h) type of footwear;

i) size in the stitch-mass system;

j) color;

k) upper material;

l) lining material;

m) sole material;

n) manufacturer's model (article number);

o) functional purpose;

p) medical purpose according to the severity of statodynamic function impairment;

q) registration certificate number for the medical device and name of the medical device model;

r) number and date of the declaration of conformity (if available);

s) shelf life or service life, number of months (for service life).

39. For registration of corrective insole elements for orthopedic footwear (including insoles, partial insoles) in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information about the goods being registered:

a) taxpayer identification number of the applicant;

b) product code (if available);

c) full name of the goods;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature;

f) country of production code in accordance with the Russian Classification of Countries of the World;

g) category of goods;

h) type of goods;

i) functional purpose;

j) method of use;

k) composition;

l) registration certificate number for the medical device and name of the medical device model;

m) number and date of the declaration of conformity (if available);

n) shelf life or service life, number of months (for service life).

40. For registration of coronary stents in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information about the goods being registered:

a) taxpayer identification number of the applicant;

b) product code (if available);

c) full name of the goods;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature;

f) country of production code in accordance with the Russian Classification of Countries of the World;

g) type of goods;

h) manufacturer's model (article number);

i) stent length;

j) free external diameter of the stent;

k) stent design type;

l) stent frame material;

m) registration certificate number for the medical device and name of the medical device model;

n) number and date of the declaration of conformity (if available);

o) shelf life or service life, number of months (for service life).

41. For registration of sanitary and hygienic products used for incontinence in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information about the goods being registered:

a) taxpayer identification number of the applicant;

b) product code (if available);

c) full name of the goods;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature;

f) country of production code in accordance with the Russian Classification of Countries of the World;

g) category of goods;

h) type of goods;

i) number of units of consumption in the consumer packaging;

j) absorption capacity (moisture absorption);

k) composition;

l) waist (hip) circumference (for adult diapers);

m) product size (for adult absorbent pads);

n) target gender (for urological pads and liners);

o) registration certificate number for the medical device and name of the medical device model;

p) number and date of the state registration certificate and (or) declaration of conformity (if available);

q) shelf life or service life, number of months (for service life).

41(1). For registration of medical gloves in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information about the goods being registered:

a) taxpayer identification number of the applicant;

b) product code (if available);

c) full name of the goods;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature;

f) country of production code in accordance with the Russian Classification of Countries of the World;

g) category of goods;

h) type of goods;

i) number of units of consumption in the consumer packaging;

j) product size;

k) composition;

l) registration certificate number for the medical device and name of the medical device model;

m) number and date of the declaration of conformity (if available);

n) shelf life or service life, number of months (for service life).
(Clause 41(1) introduced by Resolution of the Government of the Russian Federation No. 860 of June 26, 2024)

42. For registration of a set in the subsystem of the national catalog of marked goods, the participant in the circulation of goods shall submit the following information:

a) taxpayer identification number of the applicant;

b) product code in respect of the set (if available);

c) full name of the set;

d) trademark (if available);

e) 10-digit code of the commodity nomenclature (if available);

f) product codes of marked goods included in the set;

g) quantity of units of goods for each product code of marked goods included in the set;

h) composition of the set (optional).

43. In addition to the information specified in Clauses 37-41(1) of these Rules, the participant in the circulation of goods shall have the right to submit photographs of the goods from various angles when registering the goods.

44. In the event of a positive result of the verification of the application for registration of goods, the operator of the monitoring information system shall, no later than 3 working days from the date of receipt of such application, register the goods in the subsystem of the national catalog of marked goods and send to the applicant a notification of registration of the goods in the subsystem of the national catalog of marked goods.

In addition to the grounds provided for in Clause 29 of these Rules, the grounds for refusal to accept documents or to enter into the subsystem of the national catalog of marked goods information submitted by participants in the circulation of goods to the subsystem of the national catalog of marked goods shall be any of the following grounds:

• failure to submit the information provided for in Clauses 37, and (or) 38, and (or) 39, and (or) 40, and (or) 41, and (or) 41(1), and (or) 42 of these Rules;

• 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) engaged in the production and manufacture of medical devices.

V. Characteristics of the Identification Means, Including the Structure and Format of Marking Codes, Identification Codes and Verification Codes

45. The identification means shall be applied in the form of a two-dimensional barcode 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 code coding. Data Matrix symbology specification," approved by order of the Federal Agency for Technical Regulation and Metrology No. 509-st of December 18, 2008 and put into effect from January 1, 2010 (hereinafter - the national standard of the Russian Federation GOST R ISO/IEC 16022-2008), using ECC 200 symbology and using FNC1 as a symbology flag (having code 232 in the ASCII character table) and compliance of data with the standard format of GS1 application identifiers (AI) in accordance with Clause 5.2.4.6 of the national standard of the Russian Federation GOST R ISO/IEC 16022-2008.

46. The following requirements apply to the conversion and quality of application of identification means:

a) the conversion of the marking code into an identification means shall be carried out using the ECC 200 error correction method and the encoded set of ASCII characters in accordance with the requirements of the national standard of the Russian Federation GOST R ISO/IEC 16022-2008;

b) the print quality of the identification means must meet the requirements of the national standard of the Russian Federation GOST R ISO/IEC 15415-2012, and when applied by the participant in the circulation of goods, quality not lower than class 1.5 (C) in accordance with such national standard;

c) the recommended range of sizes of Data Matrix elements that make up the two-dimensional barcode is from 0.255 to 0.680 millimeters. The size of the identification means shall correspond to the requirements of the national standard of the Russian Federation GOST R ISO/IEC 16022-2008.

47. When converting marking codes into identification means and marking goods, service providers and participants in the circulation of goods must ensure compliance with the standards of print quality of the identification means specified in Clauses 10 and 46 of these Rules.

48. When a participant in the circulation of goods engages a service provider, the participant in the circulation of goods shall transfer the marking codes to the service provider for conversion and application through the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system to the service provider. After the conversion of the marking code into an identification means and the marking of the goods by the service provider, validation of the identification means shall be performed before transferring to the participant in the circulation of goods the consumer packaging, or group packaging, or set, or label with the applied identification means. Service providers shall submit information on the application and validation of identification means to the participant in the circulation of goods through the software and hardware complex for distribution of marking codes.

49. The printing equipment on which the conversion of the identification means is performed must ensure the necessary print resolution, where the Data Matrix code element must be from 0.255 to 0.680 millimeters, while the physical size of the Data Matrix code is determined by the amount of encoded data and the size of one element, must comply with the requirements of the national standard of the Russian Federation GOST R ISO/IEC 16022-2008, and ensure print quality of the applied marking code symbols of not lower than class 1.5 (C) at the final stage of the technological process of validation of the applied identification means immediately before shipment of the manufactured consumer packaging, or group packaging, or manufactured set, or label with identification means applied to it to the participant in the circulation of goods carrying out the packaging of goods.

50. The service provider must use certified materials that meet the sanitary and hygienic requirements of the Technical Regulation of the Customs Union "On the Safety of Packaging" (TR CU 005/2011), approved by Decision of the Customs Union Commission No. 769 of August 16, 2011.

51. The method of applying the identification means must ensure the preservation (durability) of the identification means throughout the entire shelf life or service life of the goods, subject to compliance with the storage and transportation conditions established by the manufacturer.

52. The service provider shall have the right to submit marking codes received from a participant in the circulation of goods only to another service provider. The transfer of marking codes shall be carried out for the purpose of fulfilling obligations to such participant in the circulation of goods in accordance with these Rules, exclusively using the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system.

53. The identification means contains a marking code that includes 4 groups of data identified by attributes (application identifiers - AI) provided for by the GS1 Data Matrix standard, of which the first and second groups of data form the identification code, or identification code of group packaging, or identification code of a set, the third group forms the identifier (individual serial number) of the verification key, and the fourth group forms the verification code:

a) the first group is identified by application identifier AI = '01', consists of 14 digits and contains the product code;

b) the second group is identified by application identifier AI = '21', consists of 13 characters (digits, lowercase and uppercase Latin letters, as well as special characters), contains the identifier of the member state of the Eurasian Economic Union in which the code was issued (1 - Republic of Armenia, 2 - Republic of Belarus, 3 - Republic of Kazakhstan, 4 - Kyrgyz Republic, 5 - Russian Federation) (first digit) included by the operator of the monitoring information system, and the individual serial number of the goods packaging (12 digits, lowercase and uppercase Latin letters, as well as special characters) and ends with the FNC1 separator character (ASCII 29);

c) the third group is identified by application identifier AI = '91', consists of 4 characters, contains the identifier (individual serial number) of the verification key generated by the operator of the monitoring information system, and ends with the FNC1 separator character (ASCII 29);

d) the fourth group is identified by application identifier AI = '92', consists of 44 characters (digits, lowercase and uppercase Latin letters, as well as special characters) and contains the verification code value generated by the operator of the monitoring information system.

54. The identification code of transport packaging is provided in the form of a barcode that meets the requirements of the interstate standard GOST ISO 15394-2013 "Packaging. Bar code and two-dimensional symbols for shipping, transport and receiving labels. General requirements," put into effect from January 1, 2014 by order of the Federal Agency for Technical Regulation and Metrology No. 106-st of May 15, 2013. 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.

The monitoring information system shall reflect information on the relationship of identification codes of each nested goods in consumer packaging, and (or) group packaging, and (or) set, and (or) transport packaging with the identification code of the transport packaging being created.

55. The aggregated customs code is generated by the operator of the monitoring information system, consists of a continuous sequence of 25 characters (digits, lowercase and uppercase Latin letters), includes 2 groups of data, and is formed as follows:

XXXXXXXXXXXXDDMMYYXXXXXXX,

where:

• the first group of data consists of 12 digits and contains the taxpayer identification number of the applicant, which is assigned by the operator of the monitoring information system automatically on the basis of the applicant's registration data. If the taxpayer identification number of the applicant consists of fewer digits, it is preceded by zeros (00);

• the second group of data consists of 13 characters (digits, lowercase and uppercase Latin letters). The first 6 characters of the second group of data are the date of formation by the operator of the monitoring information system of the aggregated customs code (DDMMYY), the subsequent 7 characters of the second group of data (digits, lowercase and uppercase Latin letters) are generated by the operator of the monitoring information system automatically in an arbitrary (usually sequential) order of assignment and ensure the uniqueness of the aggregated customs code for 5 years.

The aggregated customs code is generated taking into account the requirements for customs declaration of goods as a single product provided for by the Procedure for Filling Out the Customs Declaration, approved by Decision of the Customs Union Commission No. 257 of May 20, 2010 (when performing customs operations and releasing goods before filing a customs declaration, taking into account the requirements for declaring information on goods provided for by the Procedure for Filling Out the Application for Release of Goods Before Filing a Customs Declaration, approved by Decision of the Board of the Eurasian Economic Commission No. 171 of December 13, 2017).

56. Identification means in barcode format must meet the following requirements:

a) the probability of guessing the identification means must be negligibly small and in any case less than 1 in 10,000;

b) the error recognition and correction function must be equivalent to or higher than that of Data Matrix ECC 200;

c) it is recommended to use a module size of not less than 0.255 millimeters.

57. The monitoring information system does not allow re-formation (generation) of a marking code contained in an identification means.

VI. Procedure for Forming Identification Means

58. Within the processes specified in Clauses 59 and 63 of these Rules, the participant in the circulation of goods shall exchange electronic documents and information with the monitoring information system through the emission registration device.

59. To ensure the marking of goods, the participant in the circulation of goods shall send to the operator of the monitoring information system an application for obtaining marking codes (hereinafter - the application). The form and format of the application shall be approved by the operator of the monitoring information system.

60. To form the application, the participant in the circulation of goods shall send to the monitoring information system the following information:

a) taxpayer identification number of the participant in the circulation of goods;

b) method of introduction of goods into circulation:

• produced on the territory of the Russian Federation;

• imported into the Russian Federation;

• re-marking;

• sale (retail) of goods previously withdrawn from circulation under a transaction, information about which constitutes a state secret;

• sale (retail) of goods previously acquired for purposes not related to their subsequent sale (retail);

• sale (retail) of goods acquired for the purpose of further sale (retail) based on the results of tenders within the framework of enforcement proceedings and bankruptcy procedures, sale of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation;

• marking of goods in circulation on the date of commencement of mandatory marking of goods (marking of remaining goods);

c) number of requested marking codes;

d) product code for which the marking code needs to be generated;

e) individual serial number of each unit of goods if it is generated by the participant in the circulation of goods independently;

f) type of marking code (consumer packaging, group packaging, set);

g) taxpayer identification number of the service provider, if the marking of goods is intended to be carried out using the services of a service provider.

61. The operator of the monitoring information system shall refuse to issue marking codes if any of the following requirements are violated:

a) the application does not comply with the requirements of Clause 60 of these Rules;

b) the participant in the circulation of goods is not registered in the monitoring information system;

c) the monitoring information system does not contain information about the emission registration device through which the application was sent;

d) the identification codes, or identification codes of group packaging, or identification codes of sets specified in the application have previously been registered in the monitoring information system;

e) the product code is not registered in the monitoring information system.

62. Within 4 hours from the moment of registration of the application in the monitoring information system, the operator of the monitoring information system, using the means of the monitoring information system, shall form (generate) the number of marking codes specified in the application and enter the corresponding identification codes, or identification codes of group packaging, or identification codes of sets into the monitoring information system.

63. After entering the identification codes, or identification codes of group packaging, or identification codes of sets specified in the application into the monitoring information system, the operator of the monitoring information system shall, using the means of the monitoring information system, send to the applicant's emission registration device information on the marking codes provided under the application.

64. When independently marking goods, the participant in the circulation of goods, after receiving the marking code, shall convert it into an identification means, ensure the marking of the goods, and within 30 calendar days from the date of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application, shall transmit to the monitoring information system a report on the application of identification means in the following composition:

• taxpayer identification number of the participant in the circulation of goods;

• marking code converted into an identification means applied to consumer packaging, or group packaging, or set, or label placed on such consumer packaging, group packaging or set;

• date of production;

• expiration date;

• batch number and (or) individual factory serial number.

The conversion of marking codes paid for by the participant in the circulation of goods before they are provided by the operator of the monitoring information system, and the application of identification means converted from such marking codes, shall be carried out by the participant in the circulation of goods at their discretion, regardless of the period established by the first paragraph of this clause.

65. When identification means are applied by a service provider, the marking codes shall be converted by the service provider into identification means for application to consumer packaging, group packaging, set or label, followed by validation of the identification means and transfer of information on the application and validation of identification means to the participant in the circulation of goods through the software and hardware complex for distribution of marking codes. For the transfer by the service provider of marking codes and information on the application and validation of identification means, the software and hardware complex for distribution of marking codes provided by the operator of the monitoring information system shall be used.

66. After the production of goods whose marking was carried out by the service provider, the participant in the circulation of goods shall, within 365 calendar days from the date of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application, submit to the monitoring information system a report on the application of the identification means in the following composition:

• taxpayer identification number of the participant in the circulation of goods;

• marking code converted into an identification means applied to consumer packaging, or group packaging, or set, or label placed on such consumer packaging, group packaging or set;

• date of production;

• expiration date;

• batch number and (or) individual factory serial number.

The conversion of marking codes paid for by the participant in the circulation of goods before they are provided by the operator of the monitoring information system, and the application of identification means converted from such marking codes, shall be carried out by the participant in the circulation of goods at their discretion, regardless of the period established by the first paragraph of this clause.

67. Payment for the service of providing a marking code, provided for by Resolution of the Government of the Russian Federation No. 577 of May 8, 2019 "On Approval of the Amount of the Fee for the Provision of Services for the Provision of Marking Codes Necessary for Forming Identification Means and Ensuring Monitoring of the Movement of Goods Subject to Mandatory Marking with Identification Means, and on the Procedure for Its Collection," shall be made:

• in the case of marking of goods by the participant in the circulation of goods independently - before the date of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application, or within 30 calendar days from the said date, but no later than the date of introduction into circulation of the marked goods, the identification means of which is converted from the corresponding marking code;

• in the case of marking of goods by a service provider - before the date of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application, or within 365 calendar days from the said date, but no later than the date of introduction into circulation of the marked goods, the identification means of which is converted from the corresponding marking code.

At the same time, the operator of the monitoring information system shall enter into the monitoring information system information on the application of the identification means specified by the participant in the circulation of goods in the report on the application of the identification means, only after receiving payment for the service of providing the marking code converted into the corresponding identification means.

The decision on the choice of method of payment for the service of providing a marking code shall be made by the participant in the circulation of goods.

In the event that payment for the service of providing a marking code is made by the participant in the circulation of goods before the date of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application, such service shall be deemed to have been rendered by the operator of the monitoring information system at the moment of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application.

In the event that payment for the service of providing a marking code is made by the participant in the circulation of goods after the date of provision by the operator of the monitoring information system to the participant in the circulation of goods of information on the marking codes provided under the application, such service shall be deemed to have been rendered by the operator of the monitoring information system at the moment of entry by the operator of the monitoring information system into the monitoring information system of information on the marking of goods specified by the participant in the circulation of goods in the report on the application of the identification means.

68. In the event that a participant in the circulation of goods who received marking codes on a gratuitous basis, through September 30, 2023 (inclusive), has not ensured their conversion into identification means and has not submitted to the monitoring information system a report on the application of identification means and information on the introduction of goods into circulation before the said date, then from October 1, 2023, the participant in the circulation of goods shall have the right to introduce into circulation goods marked with identification means converted from such marking codes, subject to compliance with the deadline for sending to the monitoring information system the report on the application of identification means established by Clauses 64 and (or) 66 of these Rules, and payment for the said marking codes in accordance with this clause.

The service of providing a marking code in the case provided for by the first paragraph of this clause shall be deemed to have been rendered by the operator of the monitoring information system at the moment of entry by the operator of the monitoring information system into the monitoring information 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.

At the same time, the operator of the monitoring information system shall enter into the monitoring information system information on the introduction of goods into circulation after receiving payment for the service of providing the marking code.

Payment for the said service, provided for by Resolution of the Government of the Russian Federation No. 577 of May 8, 2019 "On Approval of the Amount of the Fee for the Provision of Services for the Provision of Marking Codes Necessary for Forming Identification Means and Ensuring Monitoring of the Movement of Goods Subject to Mandatory Marking with Identification Means, and on the Procedure for Its Collection," shall be made:

• in the case of marking of goods by the participant in the circulation of goods independently - within 30 calendar days from October 1, 2023, but no later than the date of introduction into circulation of marked goods, the identification means of which are converted from the corresponding marking codes received through September 30, 2023 (inclusive);

• in the case of marking of goods by a service provider - subject to payment for the said marking codes within 365 calendar days from October 1, 2023, but no later than the date of introduction into circulation of marked goods, the identification means of which are converted from the corresponding marking codes.

69. Marking codes shall be cancelled in the following cases:

a) within the periods established by Clauses 67 or 68 of these Rules, the participant in the circulation of goods has not made payment for the services of providing these marking codes;

b) within the periods established by Clauses 64 and (or) 66 of these Rules, the participant in the circulation of goods has not sent to the monitoring information system a report on the application of identification means converted from these marking codes.

70. The entry by the operator of the monitoring information system into the monitoring information system of information on the application of identification means shall be refused for the following reasons:

a) absence of the identification codes specified in the report on the application of identification means in the monitoring information system;

b) submission by the participant in the circulation of goods of the report on the application of identification means after the expiration of the period established by Clauses 64 and (or) 66 of these Rules;

c) absence in the monitoring information system of information on the emission registration device through which the participant in the circulation of goods sent the report on the application of identification means;

d) absence from the operator of the monitoring information system of confirmation of payment for the marking codes converted into identification means, the report on the application of which is to be transmitted to the monitoring information system in accordance with Clauses 64 and (or) 66 of these Rules.

VII. Procedure for Applying Identification Means

71. Marking of goods shall be carried out by the manufacturer or importer, including through the use of the services of a service provider:

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 - before the introduction of goods into circulation;

b) in cases of import of goods into the Russian Federation:

• from the territories of states that are not members of the Eurasian Economic Union, as well as in the case of import into the rest of the territory of the Russian Federation of goods produced on the territories of special (free) economic zones or territories equivalent to them from foreign raw materials and (or) components placed under the customs procedure of a free customs zone, as well as goods produced on the territory of a free warehouse from foreign raw materials and (or) components placed under the customs procedure of a free warehouse - before they are placed under the customs procedures of release for domestic consumption or reimportation;

• from the territories of member states of the Eurasian Economic Union within the framework of cross-border trade - before crossing the state border of the Russian Federation.

72. Participants in the circulation of goods who have decided to sell goods acquired for purposes not related to their subsequent sale (retail), or to sell (retail) goods acquired from a party to a transaction, information about which constitutes a state secret, or acquired based on the results of tenders within the framework of enforcement proceedings and bankruptcy procedures, sale of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation, must ensure the marking of unmarked goods before their sale (retail) to third parties, including before their display at the place of sale (retail) or demonstration of their samples.

73. Participants in the circulation of goods must ensure the re-marking of goods supplied (sold) within the framework of purchase and sale transactions, as well as commission agreements, including those offered for sale (retail) after their return by the buyer, in the event of loss or damage to the identification means that precludes the possibility of its reading (recognition).

74. In the case of formation of a set, the identification means shall be applied to the set or to the label placed on such set, as well as to the consumer packaging of goods included in this set, or to the label placed on such consumer packaging.

75. The identification means shall be applied to consumer packaging, or group packaging, or set, or label placed on such consumer or group packaging, or set, by a method that does not allow the separation of the identification means without damaging the identification means.

The identification means may not be applied to structurally separable parts of consumer packaging without damage, nor shall it be printed on transparent shrink film or on any other external wrapping material.

76. The location of the identification means applied to consumer packaging, or group packaging, or set, must ensure unobstructed reading by technical means designed for reading Data Matrix and EAN-128 codes.

At the same time, the identification means must be positioned in such a way that the integrity of information applied to consumer packaging, or group packaging, or set in accordance with the requirements of technical regulation legislation is not violated.

VIII. Procedure and Deadlines for Submission by Participants in the Circulation of Goods to the Monitoring Information System of Information on the Introduction into Circulation, Circulation, and Withdrawal from Circulation of Goods for Inclusion in the Monitoring Information System

77. Manufacturers (including within the framework of contract manufacturing) before offering goods for wholesale or retail sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples (except for the submission of information on goods when selling them remotely), or third-party manufacturers of goods before transferring goods to the manufacturer, shall generate a notification of the introduction of goods into circulation and submit to the monitoring information system the following information:

• taxpayer identification number of the manufacturer;

• 10-digit code of the commodity nomenclature;

• identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging;

• type of production order (own production, contract manufacturing);

• taxpayer identification number of the owner of the goods (in the case of contract manufacturing);

• registration number and date of issue (registration) of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

• date and number of the registration certificate for the medical device.

The submission of information on the transfer of goods released within the framework of contract manufacturing from a third-party manufacturer of goods to the manufacturer shall be carried out in accordance with Clause 94 of these Rules.

78. Importers, after the release by customs authorities of goods imported (brought in) and placed under customs procedures of release for domestic consumption or reimportation, before offering such goods for sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples, or before accepting for accounting of goods imported into the Russian Federation for purposes not related to their subsequent sale (retail), shall generate a notification of the introduction of goods into circulation and submit to the monitoring information system the following information:

a) taxpayer identification number of the importer;

b) identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code;

c) date of registration of the customs declaration or other document used as a customs declaration, under which the release of goods was carried out in accordance with the customs procedures of release for domestic consumption or reimportation (hereinafter - the customs document);

d) registration number of the customs document;

e) registration number and date of issue (registration) of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

f) date and number of the registration certificate for the medical device.

79. For the purposes of customs declaration of goods and transfer to the monitoring information system of the notification of the introduction of goods into circulation, taking into account the requirements provided for in Clause 78 of these Rules, identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, and (or) identification codes of transport packaging, and (or) aggregated customs code shall be subject to indication in customs documents in accordance with the Procedure for Filling Out the Customs Declaration, approved by Decision of the Customs Union Commission No. 257 of May 20, 2010, or the Procedure for Filling Out the Application for Release of Goods Before Filing the Customs Declaration, approved by Decision of the Board of the Eurasian Economic Commission No. 171 of December 13, 2017.

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) aggregated customs code already contained in another customs document or in the same customs document, with the exception of cases of adoption of a decision on refusal of release, withdrawal, cancellation of the customs document, as well as indication in the customs declaration submitted in respect of goods whose release was carried out under the application for release of goods before the filing of the customs declaration.

When customs declaration of goods in accordance with the customs procedures of release for domestic consumption or reimportation upon completion of the customs procedures of a free customs zone and a free warehouse for the purpose of export of produced and introduced into circulation goods from the territories of special (free) economic zones, territories equivalent to them, and territories of free warehouses to the rest of the territory of the Russian Federation, identification codes, and (or) identification codes of group packaging, and (or) identification codes of sets, or identification codes of transport packaging, or aggregated customs code shall not be indicated in the customs declaration.

80. The aggregated customs code shall be generated by the operator of the monitoring information system upon application submitted by the importer to the monitoring information system and containing the following information:

a) taxpayer identification number of the importer;

b) 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.

81. 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, before displaying them at the place of sale (retail), demonstrating their samples, or providing information about them at the place of sale (retail) of goods, shall generate a notification of the introduction of goods into circulation and submit to the monitoring information system the following information:

a) taxpayer identification number of the participant in the circulation of goods carrying out the import of goods within the framework of cross-border trade;

b) 10-digit code of the commodity nomenclature;

c) identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging;

d) name of the member state of the Eurasian Economic Union from whose territory the import of goods is carried out (in accordance with the Russian Classification of Countries of the World);

e) cost of marked goods (including value added tax, if the transaction is subject to such tax) according to primary documents;

f) name of the supplier organization;

g) taxpayer identification number of the sender (or its equivalent in the sender's country);

h) details of the consignment document confirming the import of goods into the Russian Federation from the territory of another member state of the Eurasian Economic Union;

i) registration number and date of issue (registration) of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

j) date and number of the registration certificate for the medical device.

82. The monitoring information 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 about marked goods:

a) name of the owner of identification codes, or identification codes of group packaging, or identification codes of sets, or identification codes of transport packaging, or aggregated customs code;

b) taxpayer identification number, name of the taxpayer - owner of identification codes, or identification codes of group packaging, or identification codes of sets, or identification codes of transport packaging, or aggregated customs code;

c) identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code;

d) status of the identification code, or status of the identification code of group packaging, or status of the identification code of a set, or status of the identification code of transport packaging, or status of the aggregated customs code;

e) 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;

f) date of the last change of status of the identification code, or status of the identification code of group packaging, or status of the identification code of a set, or status of the identification code of transport packaging, or status of the aggregated customs code;

g) 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 to the warehouse;

h) 10-digit code of the commodity nomenclature;

i) tax registration reason code of the participant in the circulation of goods (if available);

j) registration number of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

k) date of issue (registration) of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

l) date of the registration certificate for the medical device;

m) number of the registration certificate for the medical device;

n) trademark (if available).

83. The Unified Automated Information System of Customs Authorities shall transmit to the monitoring information system, upon request of the monitoring information system, the following information on the results of customs control of marked goods:

a) type of customs document;

a(1)) code of the customs authority that made the decision on the customs document;
(subclause "a(1)" introduced by Resolution of the Government of the Russian Federation No. 1630 of November 26, 2024)

b) registration number and date of issue (registration) of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

c) date and number of the registration certificate for the medical device;

d) registration number of the customs document;

e) date of registration of the customs document;

f) code of the customs procedure;

g) code of declaration feature;

h) name of the sender organization;

i) code of the sender's country;

j) name of the sender's country;

k) name of the recipient organization;

l) taxpayer identification number of the recipient;

m) name of the organization (individual entrepreneur) of the declarant of goods;

n) taxpayer identification number of the declarant of goods;

o) 10-digit code of the commodity nomenclature;

p) 3-digit alphabetic code of the contract price currency;

q) customs value of goods;

r) price of goods (invoice value);

s) code of the country of origin in accordance with the Russian Classification of Countries of the World;

t) quantity of goods in the additional unit of measurement;

u) name of the additional unit of measurement;

v) code of the additional unit of measurement;

w) name of goods;

x) serial number of the goods;

y) identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code;

z) amount of value added tax paid to the budget of the Russian Federation in respect of the imported goods;

aa) gross weight, net weight;

ab) code of the decision on the goods in accordance with the classifier of decisions made by the customs authority;

ac) date and time of the decision made on the goods in accordance with the classifier of decisions.

84. When making changes (additions) to the information declared in the customs declaration after the release of goods, the Unified Automated Information System of Customs Authorities shall transmit, upon request, to the monitoring information system the adjusted data on the goods, as well as information on the customs declaration submitted in respect of goods whose release was carried out on the basis of the application for release of goods before the filing of the customs declaration.

85. Information on the decision of the customs authority in respect of marked goods received from the Unified Automated Information System of Customs Authorities shall be reflected in the monitoring information system.

86. Participants in the circulation of goods who have decided to sell goods acquired based on the results of tenders within the framework of enforcement proceedings and bankruptcy procedures, sale of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation, shall generate a notification of the introduction of goods into circulation and enter into the monitoring information system the following information before offering these goods for sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples:

a) taxpayer identification number of the participant in the circulation of goods carrying out the said circulation;

b) identification code, or identification code of group packaging, or identification code of a set;

c) details of the primary accounting document confirming the acceptance of goods acquired based on the results of tenders within the framework of enforcement proceedings and bankruptcy procedures, sale of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted in accordance with the legislation of the Russian Federation into the ownership of the Russian Federation.

87. Participants in the circulation of goods shall have the right, before the introduction of goods into circulation, to place information about such goods, including descriptions of goods, their images and cost, on the Internet when selling goods remotely, in catalogues, prospectuses, booklets, photographs, means of communication (television, postal, radio communications, etc.) or by other means that exclude the possibility of direct inspection by the consumer of the goods or their samples for the sale (retail) of goods remotely, as well as to conclude retail purchase and sale agreements for goods remotely 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 agreement concluded remotely before the introduction of goods into circulation shall be permitted only after the introduction of goods into circulation.

88. Participants in the circulation of goods, if necessary, shall carry out the operation of forming a set and submit to the monitoring information system, before offering this set for sale (retail), including before displaying it at the place of sale (retail) or demonstrating its samples (except for the submission of information about it when selling goods remotely), the following information:

a) taxpayer identification number of the participant in the circulation of goods;

b) identification code of the set;

c) list of identification codes included in the set of goods.

89. When aggregating consumer packaging into group packaging before transferring the group packaging to the next participant in the circulation of goods, the participant in the circulation of goods who carried out the aggregation shall submit to the monitoring information system the following information:

• identification code of the group packaging;

• list of identification codes of the aggregated consumer packaging;

• date of aggregation.

Information on the aggregation of goods in consumer packaging into group packaging may be transmitted simultaneously with information on the aggregation of group packaging into transport packaging before transferring the transport packaging to the next participant in the circulation of goods.

90. Participants in the circulation of goods carrying out the operation of aggregating goods into transport packaging shall submit to the monitoring information system the following information:

a) the result of performing the first-level aggregation operation by submitting the following information:

• taxpayer identification number of the participant in the circulation of goods who carried out the aggregation of goods into first-level transport packaging;

• identification code of the transport packaging being created, as well as a 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;

b) the result of performing the subsequent-level aggregation operation by submitting the following information:

• taxpayer identification number of the participant in the circulation of goods who carried out the aggregation of goods into subsequent-level transport packaging;

• identification code of the higher-level transport packaging being created, as well as a list of identification codes of transport packaging to be included in the identification code of the higher-level transport packaging being created.

91. Participants in the circulation of goods carrying out the operation of unformation of transport packaging shall submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods who carried out the unformation of transport packaging;

• identification codes of transport packaging to be unformed.

In the event that participants in the circulation of goods submit to the monitoring information system information on the circulation or withdrawal from circulation of part of the goods that, according to the data of the monitoring information system, are in transport packaging, the monitoring information system shall automatically register the unformation of all transport packaging of a higher level of nesting that contained the goods removed from the said packaging.

92. Participants in the circulation of goods, if necessary, shall carry out the operation of unformation of group packaging or a set and submit to the monitoring information system the following information:

a) taxpayer identification number of the participant in the circulation of goods who carried out the operation of unformation of group packaging or a set;

b) list of identification codes of group packaging to be unformed, or identification codes of sets to be unformed.

93. Participants in the circulation of goods carrying out operations for the removal and rearrangement of goods within the framework of first-level transport packaging or first-level transport packaging within the framework of subsequent-level transport packaging shall submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods who carried out the removal or rearrangement operations;

• type of transformation operation (rearrangement, removal);

• 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.

The unformation of the identification code of first-level and subsequent-level transport packaging shall be carried out only if, as a result of the packaging transformation operation, no other first-level transport packaging, or goods in consumer packaging, or goods in group packaging, or sets remain in the first-level transport packaging.

94. When transferring (accepting) goods within the framework of transactions providing for the transfer of ownership of the said goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contracts, and (or) commission agreements, the participant in the circulation of goods carrying out the shipment (acceptance) of goods shall generate a notification of the transfer (acceptance) of goods (in the format of a universal transfer document indicating the type of transaction within which the shipment is carried out), sign it with a strengthened electronic signature and send it to the other party to the transaction in accordance with the procedure provided for in Clause 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 monitoring information system by the operator of electronic document management.

The said notification must contain the following mandatory information:

• taxpayer identification number of the buyer;

• unit of measurement (code and its corresponding conventional designation (national) in accordance with the Russian Classification of Units of Measurement) (if available);

• quantity of goods supplied (shipped);

• price of goods per unit of measurement excluding value added tax, and in the case of application of state regulated prices (tariffs) that include value added tax, including the amount of tax;

• cost of the entire quantity of goods supplied (shipped) excluding value added tax (in cases provided for by the Tax Code of the Russian Federation, the tax base shall be indicated);

• tax rate;

• cost of the entire quantity of goods supplied (shipped) including value added tax;

• amount of value added tax charged to the buyer of goods;

• identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging.

95. The operator of the monitoring information system, after receiving a notification from the operator of electronic document management or an acceptance document in accordance with the procedure provided for in Clause 33 of these Rules, shall reflect in the monitoring information system the fact of transfer of goods between participants in the circulation of goods.

96. Participants in the circulation of goods selling marked goods using cash register equipment shall send to the monitoring information system information on the circulation of goods if the transaction is carried out between participants in the circulation of goods registered in the monitoring information system, or on the withdrawal of goods from circulation through cash register equipment, and when carrying out operations to adjust the information initially submitted on the price of goods per unit taking into account discounts, markups, fees and taxes, the cost of goods taking into account discounts, markups, fees and taxes, the value added tax rate included in the cost of goods, on the withdrawal of marked goods from circulation through cash register equipment, shall send to the monitoring information system information on the adjustment of the withdrawal of goods from circulation through cash register equipment.

97. A participant in the circulation of goods selling goods using cash register equipment shall identify and recognize, using software and (or) technical means interfaced with the cash register equipment installed and registered with them, the identification means applied to the goods.

98. In the presence of an agreement with a participant in the circulation of goods making payments for goods or accepting returned goods with an undamaged identification means in accordance with the Federal Law "On the Use of Cash Register Equipment in Making Payments in the Russian Federation," the operator of fiscal data, on behalf of such participant in the circulation of goods, shall carry out daily real-time transfer on their behalf of information received from them to the operator of the monitoring information system for each sold unit of marked goods in accordance with the protocol for information exchange between the operator of fiscal data and the monitoring information system, including the following mandatory information:

a) taxpayer identification number of the user of the cash register equipment (except for cases established by the Federal Law "On the Use of Cash Register Equipment in Making Payments in the Russian Federation");

b) document form code;

c) document serial number;

d) date and time of document generation;

e) calculation attribute - receipt (receipt of funds from the buyer), return of receipt (return to the buyer of funds received from them), disbursement (issuance of funds to the buyer), return of disbursement (receipt from the buyer of funds issued to them);

f) marking code, or identification code, or identification code of group packaging, or identification code of a set as part of the "product code" requisite;

g) data on each unit of goods (status of goods (if available), price per unit of the item of calculation taking into account discounts and markups, fees and taxes, quantity of units of goods, cost of the item of calculation taking into account discounts and markups, fees and taxes, indicating the value added tax rate included in the cost of goods);

h) registration number of the cash register equipment;

i) serial number of the fiscal accumulator;

j) address and place of calculation (except for cases established by the Federal Law "On the Use of Cash Register Equipment in Making Payments in the Russian Federation");

k) tax system applied by the user when making payments for marked goods;

l) taxpayer identification number of the buyer (client) (when making payments using cash register equipment between organizations and (or) individual entrepreneurs);

m) data on the sale of unpacked consumer packaging (the number of sold unmarked parts and the total number of parts in the consumer packaging).

99. Information on payments made using cash register equipment between participants in the circulation of goods shall be equivalent to the notification of the transfer (acceptance) of goods provided for in Clause 94 of these Rules, and shall be the basis for the operator of the monitoring information system to reflect in the monitoring information system the fact of acceptance and transfer of goods.

100. In the absence of an agreement with the operator of fiscal data for the transfer of information on behalf of and on behalf of the participant in the circulation of goods to the operator of the monitoring information system, or in the absence of the technical capability of the operator of fiscal data to transfer, on behalf of and on behalf of the participant in the circulation of goods, information on the sale of marked goods received from the cash register equipment of the participant in the circulation of goods, the obligation to transfer information on the circulation of goods in the event that the transaction is carried out between participants in the circulation of goods registered in the monitoring information system, or on the withdrawal of goods from circulation, shall be fulfilled by the participant in the circulation of goods no later than 30 calendar days from the date of sale of goods through the participant's personal account or through information electronic services using standard data transfer protocols and electronic interaction interfaces of the monitoring information system.

101. A notification of registration in the monitoring information system of information on the circulation of marked goods in the event that the transaction is carried out between participants in the circulation of goods registered in the monitoring information system, or on the withdrawal of goods from circulation, or of refusal to register such information shall be sent to the operator of fiscal data and (or) to the participant in the circulation of goods who sold the goods using cash register equipment, and (or) to the participants in the circulation who accepted and transferred the goods using cash register equipment.

102. In cases of using cash register equipment in a mode that does not provide for the mandatory transfer of fiscal documents to tax authorities and the monitoring information system in electronic form through the operator of fiscal data, as well as in the event that the participant in the circulation of goods falls under the provisions of Clauses 2 and 3 of Article 2 of the Federal Law "On the Use of Cash Register Equipment in Making Payments in the Russian Federation," participants in the circulation of goods shall independently, no later than 30 calendar days from the date of sale of goods, send to the monitoring information system information on the withdrawal of goods from circulation or on the circulation of marked goods in the event that the transaction is carried out between participants in the circulation of goods registered in the monitoring information system, containing the information provided for in Clause 98 of these Rules, through the participant's personal account or through information electronic services using standard data transfer protocols and electronic interaction interfaces of the monitoring information system.

103. In the event of return of marked 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 monitoring information system, before offering such goods for sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples, information by one of the following methods:

• using cash register equipment through the operator of fiscal data in accordance with the procedures provided for in Clauses 96-101 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 their behalf in accordance with the legislation of the Russian Federation;

• independently entering into the monitoring information system the following information:

  • taxpayer identification number of the participant in the circulation of goods accepting the goods;

  • identification code, or identification code of group packaging, or identification code of a set being returned into circulation (in the case of return of goods with an undamaged identification means);

  • new identification code, or new identification code of group packaging, or new identification code of a set (in the case of return of goods with a damaged identification means or without an identification means);

  • details of documents confirming the return of marked goods.

In the event of return of goods with a damaged identification means or without an identification means (no possibility to identify the goods), the participant in the circulation of goods shall, before submitting to the monitoring information system the information provided for in the fourth through seventh paragraphs of this clause, carry out re-marking of such goods in accordance with Clauses 73 and 118 of these Rules.

104. When withdrawing goods from circulation on grounds other than retail sale, with the exception of the cases provided for in Clauses 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 to the monitoring information system the following information on the withdrawal of goods from circulation:

a) taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;

b) reason for withdrawal of goods from circulation (destruction, expiration of shelf life, loss, use for medical purposes, etc.);

c) name, date and number of the primary document on the disposal of goods from circulation;

d) identification code, and (or) identification code of group packaging, and (or) identification code of a set being withdrawn from circulation.

105. In the event of return of goods previously withdrawn from circulation due to use of goods for medical purposes, such participant in the circulation of goods shall independently submit to the monitoring information system the following information:

a) taxpayer identification number of the participant in the circulation of goods carrying out the return of goods into circulation;

b) reason for return of goods into circulation (return of goods withdrawn from circulation for medical purposes);

c) identification code, or identification code of group packaging, or identification code of a set being returned into circulation.

106. When withdrawing goods from circulation by selling them by samples or remotely, including using a vending machine or parcel terminal, the participant in the circulation of goods shall transmit to the monitoring information system by one of the following methods:

• using cash register equipment through the operator of fiscal data, information in accordance with Clauses 96-101 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 their behalf in accordance with the legislation of the Russian Federation;

• independently, no later than 3 working days following the day of shipment of goods from the storage warehouse for delivery to the vending machine or parcel terminal, or no later than the date of actual delivery of goods to the consumer:

  • taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;

  • reason for withdrawal of goods from circulation (sale of goods by samples, remote sale of goods, sale of goods using a vending machine or parcel terminal);

  • name, date and number (if any) of the primary document on the disposal of goods from circulation;

  • identification code, and (or) identification code of group packaging, and (or) identification code of a set being withdrawn from circulation;

  • cost of the goods being withdrawn from circulation (according to the accounting data of the participant in the circulation of goods).

107. In the event of return of goods previously withdrawn from circulation by selling by samples or remotely, including using a vending machine or parcel terminal, to the storage warehouse of the participant in the circulation of goods, such participant in the circulation of goods shall, before offering these goods for sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples (except for the submission of information about them when selling goods remotely), submit to the monitoring information system information by one of the following methods:

• using cash register equipment through the operator of fiscal data, information in accordance with the procedures provided for in Clauses 96-101 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 their behalf in accordance with the legislation of the Russian Federation;

• independently entering into the monitoring information system the following information:

  • taxpayer identification number of the participant in the circulation of goods carrying out the return of goods into circulation;

  • reason for return of goods into circulation (return of goods sold remotely, return of goods sold using a vending machine or parcel terminal);

  • identification code, or identification code of group packaging, or identification code of a set being returned into circulation (in the case of return of goods with an undamaged identification means);

  • new identification code, or new identification code of group packaging, or new identification code of a set (in the case of return of goods with a damaged identification means or without an identification means).

In the event of return of goods with a damaged identification means or without an identification means (no possibility to identify the goods), the participant in the circulation of goods shall, before submitting to the monitoring information system the information provided for in the fourth through seventh paragraphs of this clause, carry out re-marking of such goods in accordance with Clauses 73 and 118 of these Rules.

108. When withdrawing goods from circulation due to the placement of marked goods under the customs procedure of export, the participant in the circulation of goods carrying out the withdrawal of such goods from circulation shall submit to the monitoring information system a notification of withdrawal of goods from circulation containing the following information:

a) taxpayer identification number of the exporter;

b) identification code, or identification code of group packaging, or identification code of a set, or identification code of transport packaging, or aggregated customs code being withdrawn from circulation;

c) date of registration of the customs declaration;

d) registration number of the customs declaration.

109. When withdrawing goods from circulation due to 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 of such goods from circulation shall submit to the monitoring information system a notification of withdrawal of goods from circulation containing the following information:

a) taxpayer identification number of the participant in the circulation of goods selling (selling) the goods;

b) identification code, and (or) identification code of group packaging, and (or) identification code of a set, and (or) identification code of transport packaging being withdrawn from circulation.

110. Upon return of goods withdrawn from circulation on the basis of Clauses 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 relevant information to the monitoring information system.

Upon return of goods with an undamaged identification means, the goods shall not be re-marked, and the participant in the circulation of goods shall submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods accepting the goods;

• identification code, and (or) identification code of group packaging, and (or) identification code of a set.

Upon return of goods with a damaged identification means or without an identification means (no possibility to identify the goods), the participant in the circulation of goods shall carry out their re-marking in accordance with Clauses 73 and 118 of these Rules and submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods accepting the goods;

• new identification code, and (or) new identification code of group packaging, and (or) new identification code of a set.

111. A participant in the circulation of goods selling (selling) 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 goods, submit to the monitoring information system the following information:

a) taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;

b) identification code, and (or) identification code of group packaging, and (or) identification code of a set, and (or) identification code of transport packaging being withdrawn from circulation;

c) method of withdrawal of goods from circulation (sale of goods under a transaction, information about which constitutes a state secret);

d) date of withdrawal of goods from circulation;

e) 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 concluded (if available).

112. Upon return of goods withdrawn from circulation on the basis of Clause 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 relevant information to the monitoring information system.

Upon return of goods with an undamaged identification means, the goods shall not be re-marked, and the participant in the circulation of goods shall submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods accepting the goods;

• identification code, and (or) identification code of group packaging, and (or) identification code of a set.

Upon return of goods with a damaged identification means or without an identification means (no possibility to identify the goods), the participant in the circulation of goods shall carry out their re-marking in accordance with Clauses 73 and 118 of these Rules and submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods accepting the goods;

• new identification code, and (or) new identification code of group packaging, and (or) new identification code of a set.

113. Participants in the circulation of goods, in the event of a decision to sell (retail) 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 introduce goods into circulation in the following order:

a) mark the goods, if the goods have not previously been marked, in accordance with the procedure provided for by these Rules;

b) before displaying the goods at the place of sale (retail) or demonstrating their samples (except for the submission of information about them when selling goods remotely), generate a notification of the introduction of goods into circulation and submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods;

• identification code, and (or) identification code of group packaging, and (or) identification code of a set;

• 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 accordance with the procedure established by Clause 111 of these Rules.

114. Participants in the circulation of goods acquiring goods for use for purposes not related to their subsequent sale (retail), with the exception of participants in the circulation of goods acquiring goods not for retail sale, as well as for use in carrying out activities in the field of healthcare and the provision of social and 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 (retail) are not registered in the monitoring information system, the transfer to the monitoring information 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 (retail). Participants in the circulation of goods selling goods for use for purposes not related to their subsequent sale (retail), on the basis of the notification confirmed by the buyer confirming the transfer of ownership, no later than 3 working days from the date of shipment (transfer or acceptance) of goods, shall submit to the monitoring information system the following information:

a) taxpayer identification number of the participant in the circulation of goods carrying out the withdrawal of goods from circulation;

b) 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 (retail) (if such legal entities, branches of foreign legal entities and individual entrepreneurs are not registered in the monitoring information system);

c) identification code, and (or) identification code of group packaging, and (or) identification code of a set, and (or) identification code of transport packaging;

d) method of withdrawal of goods from circulation (sale for use of goods by the buyer for purposes not related to their further sale (retail);

e) date of withdrawal of goods from circulation;

f) price at which the goods were sold (including value added tax) according to primary documents (in the case of sale (retail);

g) name, number and date of the document confirming the fact of sale (retail).

115. 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 (retail) shall generate a notification in the format of a universal adjustment document, signed with a strengthened electronic signature by both participants in the circulation of goods, confirming the transfer of ownership from the buyer to the seller.

Upon return of goods with an undamaged identification means, the participant in the circulation of goods shall submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods accepting the goods;

• identification code, and (or) identification code of group packaging, and (or) identification code of a set;

• details of documents confirming the return of goods.

Upon return of goods with a damaged identification means or without an identification means (no possibility to identify the goods), the participant in the circulation of goods shall carry out their re-marking in accordance with Clauses 73 and 118 of these Rules and submit to the monitoring information system the following information:

• taxpayer identification number of the participant in the circulation of goods accepting the goods;

• new identification code, and (or) new identification code of group packaging, and (or) new identification code of a set;

• details of documents confirming the return of goods.

116. Participants in the circulation of goods who have decided to sell (retail) goods previously acquired by them for purposes not related to their subsequent sale (retail) shall, if necessary, carry out re-marking of the goods and, before offering these goods for sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples (except for the submission of information about them when selling goods remotely), submit to the monitoring information system a notification of introduction into circulation containing the following information:

a) taxpayer identification number of the participant in the circulation of goods;

b) identification code, or identification code of group packaging, or identification code of a set being returned into circulation (if the identification means is not damaged and not lost);

c) new identification code, or identification code of group packaging, or identification code of a set (if necessary, if the identification means is lost or damaged).

117. Participants in the circulation of goods, when introducing into circulation goods not sold as of the date of introduction of mandatory marking of goods, before offering these goods for sale (retail), shall submit to the monitoring information system a notification of introduction into circulation containing the following information:

a) taxpayer identification number of the participant in the circulation of goods;

b) identification code, or identification code of group packaging, or identification code of a set;

c) registration number and date of issue (registration) of the permitting document if there are requirements for confirmation of conformity and (or) state registration of the goods;

d) date and number of the registration certificate for the medical device.

118. When it is necessary to carry out re-marking in the event of damage or loss of the identification means applied to consumer packaging, or of the label with the applied identification means, the participant in the circulation of goods engaged in trade in goods, before offering these goods for sale (retail), including before displaying them at the place of sale (retail) or demonstrating their samples (except for the submission of information about them when selling goods remotely), shall submit to the monitoring information system the following information:

a) identification code, or identification code of group packaging, or identification code of a set of the new identification means;

b) identification code, or identification code of group packaging, or identification code of a set of the damaged or lost identification means (if available).

IX. Procedure for Amending Information Contained in the Monitoring Information System

119. In the event of amendment of the information provided for in 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 amendment, send to the monitoring information system a notification of the amendment of such information.

120. If, before the transfer to the monitoring information 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:

a) the participant in the circulation of goods who carried out the shipment (transfer) of goods shall generate 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) clarifying the information on the transfer (acceptance) of goods, signed with a strengthened electronic signature by both participants in the circulation of goods, and send it to the monitoring information system through the operator of electronic document management;

b) the operator of the monitoring information system, after receiving the notification clarifying the information on the transfer (acceptance) of goods signed with strengthened electronic signatures by both participants in the circulation of goods, shall reflect in the register of identification means of the monitoring information system the fact of 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.

121. If, after the acceptance of goods and the transfer of information thereon to the monitoring information system, the participants in the circulation of goods establish that the information specified in the transfer documents requires correction or adjustment, then:

a) the participant in the circulation of goods who carried out the shipment (transfer) of goods shall generate 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) clarifying the information on the transfer (acceptance) of goods, signed with a strengthened electronic signature by both participants in the circulation of goods, and send it to the monitoring information system through the operator of electronic document management;

b) the operator of the monitoring information system, after receiving the notification clarifying the information on the transfer (acceptance) of goods signed with strengthened electronic signatures by both participants in the circulation of goods, shall reflect in the register of identification means of the monitoring information system the fact of 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.

122. To cancel or correct previously submitted to the monitoring information system information on the withdrawal of goods from circulation by means other than retail sale, the participant in the circulation of goods shall send to the monitoring information system a notification of cancellation of the previously sent notification, indicating its details, and, if necessary, submit a new notification containing the information specified in Clause 104 of these Rules.

123. It is not permitted to make changes to the monitoring information system concerning previously submitted by the participant in the circulation of goods to the monitoring information system information on the introduction of goods into circulation, circulation of goods, and withdrawal of goods from circulation during the period of an inspection by the authorized federal executive body of the activities of the participant in the circulation of goods who sent the notification of amendment of information.

124. In the event of a need to make changes to the information of the monitoring information system submitted in accordance with the procedure provided for in Clause 33 of these Rules, the corrected acceptance document, signed by both parties to the contract in the procurement information system in accordance with the procedure established by Part 14 of Article 94 of the Federal Law on the Contract System, shall be sent to the monitoring information system in accordance with the procedure provided for in Clause 33 of these Rules.