Government of the Russian Federation resolution dated May 31, 2023 N 894

About approving the Rules labeling of certain types of medical devices by means of identification and features of state support implementation information system for monitoring the turnover of goods, subject to mandatory marking by means of identification, for certain types of medical devices

The Government of the Russian Federation decides:

1. Approve the attached Rules for labeling certain types of medical devices by means of identification.

2. Establish that participants in the turnover of certain types of medical devices in accordance with the Rules approved by this resolution:

a) submit to the state information system for monitoring the turnover of goods subject to mandatory labeling by means of identification (hereinafter referred to as the monitoring information system) an application for their registration in the monitoring information system starting from September 1, 2023, but not later than 7 calendar days from the date when it becomes necessary for a participant in the turnover of certain types of with the introduction into circulation, and (or) turnover, and (or) withdrawal from circulation of certain types of medical devices, in respect of which there is a ban on the introduction into circulation, and (or) turnover, and (or) withdrawal from circulation of certain types of medical devices without marking by means of identification (with the exception of participants in the turnover of certain types medical devices that fall under the provisions of paragraphs 3 and 7 of Article 2 of the Federal Law "On the use of cash registers for payments in the Russian Federation" (hereinafter referred to as participants in the turnover of certain types of medical devices in remote or hard-to-reach areas).

At the same time, participants in the turnover of certain types of medical devices in remote or hard-to-reach areas register in the monitoring information system within 30 calendar days from the date when they need to carry out activities related to the introduction into circulation, and (or) turnover, 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 an application to the monitoring information system operator for passing information interaction testing in electronic form;

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

d) pass testing of information interaction between their own software and hardware and the information monitoring system in accordance with the procedure posted on the official website of the operator of the information monitoring system in the information and telecommunications network "Internet", in relation to operations related to the labeling of certain types of medical devices, their entry into circulation, turnover 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 its own software and hardware for information interaction with the information monitoring system and sending an application in accordance with subparagraph "b" of this paragraph.

3. Establish that:

a) participants in the turnover of certain types of medical products that have a valid registration certificate for a medical product, who put certain types of medical products into circulation, put identification tools on consumer packaging, including by applying a label containing the identification tool to such consumer packaging, the specified individual types of medical products, and submit information to the information monitoring system on the application of identification tools and the introduction into circulation of these individual types of medical devices in accordance with the Rules approved by this resolution:

in relation to decontaminators-air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air), orthopedic shoes and removable corrective elements for orthopedic shoes (including insoles, half-soles) (codes of the unified Commodity Nomenclature for foreign Economic activity of the Eurasian Economic Union8421 39 200 8, 8421 39 800 6, 8539 49 000 0, 9018 20 000 0, 9021 10 100 0, codes of the All-Russian product classifier by type of economic activity 28.25.14.110, 32.50.22.150, 32.50.22.151, 32.50.22.152, 32.50.22.155, 32.50.22.156, 32.50.22.157, 32.50.50.190, codes of the type of medical device in accordance with the nomenclature classification of medical devices 131980, 152690, 152700, 182750, 209360, 250220, 250230, 250250, 250260, 292620, 320560, 336330, 343610, 375930) starting from October 1, 2023.

with respect to hearing aids, except for parts and accessories, coronary stents, computed tomographs, sanitary and hygienic products used for incontinence (codes of the unified Commodity Nomenclature for Foreign Economic Activity of the Eurasian Economic Union9021 40 000 0, 9021 90 900 1, 9022 12 000 0, 9022 13 000 0, 9022 14 000 0, 9022 19 000 0, 9619 00 890, codes of the All-Russian classifier of products by types of economic activity 17.22.12.130, 26.60.11.111, 26.60.11.113, 26.60.11.119, 26.60.14.120, 32.50.22.190, 32.50.22.195, codes of the type of medical device in accordance with the nomenclature classification of medical devices 113850, 126750, 135190, 135820, 142570, 155760, 155800, 155820, 173110, 202800, 202810, 204370, 210000, 218190, 228560, 233730, 233860, 233900, 273880, 280360, 280730, 282030, 302870, 320550, 331320, 331330, 331830, 343410, 343540, 343580, 356150), effective March 1, 2024

At the same time, participants in the turnover of certain types of medical devices that put these individual types of medical devices into circulation, from the date of entry into force of this resolution, have the right to apply identification means on consumer packaging, including by applying a label containing the identification means specified in paragraphs two and three of this sub item of certain types of medical devices information about the application of identification devices and the introduction into circulation of the specified individual types of medical devices in accordance with the Rules approved by this resolution, and also has the right to submit to the monitoring information system information about the turnover and withdrawal from circulation of certain types of medical devices in accordance with the Rules approved by this resolution, subject to the requirements of paragraph 9 of this resolution;

b) participants in the turnover of certain types of medical devices submit to the information monitoring system, in accordance with the Rules approved by this resolution, information on the withdrawal from circulation of certain types of medical devices from September 1, 2024, information on the turnover of certain types of medical devices (with the exception of sanitary and hygienic products used for incontinence) in accordance with the Rules approved by this resolution, from September 1, 2025, information on the turnover of sanitary and hygienic products used for incontinence, in accordance with the Rules approved by this resolution, from March 1, 2026.

(ed. Decree of the Government of the Russian Federation No. 1409 of 12.09.2025)

At the same time, participants in the turnover of certain types of medical devices have the right to submit to the information monitoring system information on the turnover 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 turnover of certain types of medical devices in remote or hard-to-reach areas 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 when transferring (accepting) certain types of medical devices in the framework of transactions involving the transfer of ownership of these goods, as well as in the framework of commission agreements, and (or) agency agreements, and (or) contract agreements, and (or) assignment agreements;

from the date of withdrawal of certain types of medical devices from circulation when certain types of medical devices are withdrawn from circulation;

from the date of return of certain types of medical devices to circulation in case of such return;

from the date of changing the information provided for in sections III, IV, VIII and IX of the Rules approved by this resolution, in case of changing such information;

d) participants in the turnover of certain types of medical products carry out marking of certain types of medical products imported (imported) and placed under the customs procedures of release for domestic consumption or re-import, before offering these individual types of medical products for sale (sale) and enter information on marking of such individual types of medical products by means of identification in the monitoring information system. in accordance with the Rules approved by this resolution:

with respect to decontaminators-air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air), orthopedic shoes and removable corrective elements for orthopedic shoes (including insoles, half-soles) purchased before September 30, 2023 (inclusive) and issued by customs authorities starting from October 1, 2023 to October 31, 2023 (inclusive);

with respect to hearing aids, except for parts and accessories, coronary stents, computed tomographs, sanitary and hygienic products used for incontinence, purchased before February 29, 2024 (inclusive) and issued by customs authorities starting from March 1, 2024 to March 31, 2024 (inclusive);

e) participants in the turnover of certain types of medical products in the presence of unrealized individual types of medical products on the territory of the Russian Federation have the right to sell such medical products without marking by means of identification before the expiration of their expiration date (with the exception of certain types of medical products that have a service life) or to mark by means of identification of such medical products and provide information on the marking of individual types of medical products. types of medical devices by means of identification to the monitoring information system in accordance with the Rules approved by this resolution, until August 31, 2024 (inclusive):

with respect to decontaminators-air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air), orthopedic shoes and removable corrective elements for orthopedic shoes (including insoles, half-soles) that were put into circulation before September 30, 2023 (inclusive) and were not sold at the end of the year. as of October 1, 2023.

with respect to hearing aids, except for parts and accessories, coronary stents, computed tomographs, sanitary and hygienic products used for incontinence, put into circulation before February 29, 2024 (inclusive) and not sold as of March 1, 2024.

Participants in the turnover of certain types of medical products that have a service life, if there are such unrealized individual types of medical products on the territory of the Russian Federation, have the right to sell such medical products without marking by means of identification or to mark them by means of identification and submit information on the marking of such individual types of medical products by means of identification to the monitoring information system in accordance with the Rules established by the Legislation of the Russian Federation. approved by this resolution, until August 31, 2024 (inclusive):

(ed. Decree of the Government of the Russian Federation No. 392 of 29.03.2024)

with respect to decontaminators-air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air), orthopedic shoes and removable corrective elements for orthopedic shoes (including insoles, half-soles) that were put into circulation before September 30, 2023 (inclusive) and were not sold at the end of the year. as of October 1, 2023.

with respect to hearing aids, except for parts and accessories, coronary stents, computed tomographs, sanitary and hygienic products used for incontinence, put into circulation before February 29, 2024 (inclusive) and not sold as of March 1, 2024.

At the same time, participants in the turnover of certain types of medical devices that have a service life, who purchased such medical devices for carrying out activities in the field of healthcare and providing social and medical services, have the right to store, transport and transfer such medical devices free of charge, provided for in paragraphs five and six of this sub item, without marking by means of identification such medical devices in accordance with the fourth paragraph of this paragraph.

(the paragraph was introduced by Decree of the Government of the Russian Federation No. 392 of 29.03.2024)

In the cases specified in paragraphs one and (or) four of this sub item, a participant in the turnover of certain types of medical devices registers such medical devices in the subsystem of the national catalog of labeled goods of the information monitoring system and indicates the information provided пунктами 37for in paragraphs 37-4141 of the Rules approved by this resolution, ensures their labeling, and also provides information on their labeling by means of identification to the monitoring information system in accordance with the Rules approved by this resolution.

Payment for marking codes required for the formation of identification tools for certain types of medical devices specified in paragraphs one and four of this sub item is carried out in accordance with the Rules approved by this resolution;

f) participants in the turnover of certain types of medical products that have a valid registration certificate for a medical product, who put medical gloves into circulation, put identification tools on consumer packaging, including by applying a label containing an identification tool to such consumer packaging, medical gloves, and submit information on the application of identification tools and other means of identification to the monitoring information system. introduction of medical gloves into circulation (codes of the unified Commodity Nomenclature for Foreign Economic Activity of the Eurasian Economic Union3926 20 000 0, 4015 12 000 1, 4015 12 000 9, 4015 19 000 0, codes of the All-Russian product classifier by type of 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, codes type of medical device 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 " e " was introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

g) participants in the turnover of certain types of medical devices shall submit to the information monitoring system, in accordance with the Rules approved by this resolution, information on the withdrawal from circulation of certain types of medical devices specified in subparagraph "e" of this paragraph, from March 1, 2025, information on the turnover of certain types of medical devices in accordance with the Rules approved by by this resolution, effective March 1, 2026;

(Subclause " g " was introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024; as amended by the Government of the Russian Federation. Decree of the Government of the Russian Federation No. 1409 of 12.09.2025)

h) until March 31, 2025 (inclusive), participants in the turnover of certain types of medical products carry out marking of medical gloves specified in subparagraph "e" of this paragraph, purchased until February 28, 2025 (inclusive), imported (imported) and released by customs authorities from March 1, 2025 in accordance with the customs procedure of release for medical devices. before offering such medical gloves for sale (sale), enter information on marking such medical gloves with identification means into the monitoring information system and put them into circulation in accordance with the Rules approved by this resolution;

(subclause " h " was introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

i) participants in the turnover of certain types of medical products if, as of March 1, 2025, there are in the territory of the Russian Federation unrealized medical gloves specified in subparagraph " e " of this paragraph, produced in the territory of the Russian Federation or imported into the territory of the Russian Federation before February 28, 2025 (inclusive), are entitled to: (inclusive) to implement the sale of such medical gloves without marking by means of identification or to carry out marking by means of identification of such medical gloves and submit information on marking by means of identification to the monitoring information system in accordance with the Rules approved by this resolution.

At the same time, participants in the turnover of certain types of medical products that have purchased such medical gloves for carrying out activities in the field of health care and providing social and medical services may store, transport, transfer medical gloves provided for in paragraph one of this subparagraph free of charge, without marking with identification means, and sell (sell) such medical gloves in accordance with paragraph the first of this sub item.

When carrying out marking by means of identification of medical gloves in the case specified in the first paragraph of this sub item, the participant in the turnover of certain types of medical products registers such medical gloves in the subsystem of the national catalog of marked goods of the information monitoring system and indicates the information provided for in paragraph 41 (1) of the Rules approved by this resolution,  submits information on their marking by means of identification to the monitoring information system in accordance with the Rules approved by this resolution.

Payment for marking codes required for the formation of identification tools for medical gloves specified in the first paragraph of this sub item is carried out in accordance with the Rules approved by this resolution.

(Subclauses " i " were introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

4. Registration in the information system used to ensure the conduct of the experiment in accordance with the Decree of the Government of the Russian Federation No. 137 of February 9, 2022 "On conducting an experiment on labeling certain types of medical devices with identification Devices" (hereinafter referred to as the experiment), of legal entities and individual entrepreneurs who, as of the date of registration of On August 31, 2023 were participants of the experiment, is equal to registration in the information monitoring system in accordance with subparagraph " a " of paragraph 2 of this resolution.

If the information provided during the experiment by participants in the turnover of certain types of medical devices to the information system in which information support for the experiment is provided does not meet the requirements of the Rules approved by this resolution, participants in the turnover of certain types of medical devices submit missing and (or) up-to-date information to the monitoring information system by September 30, 2023. (inclusive).

5. Establish that the operator of the information monitoring system provides:

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

b) providing participants in the turnover of certain types of medical devices with remote access to emission registration devices located in the infrastructure of the information monitoring system, under the conditions stipulated by the Rules approved by this resolution, no later than 30 calendar days from the date of receipt of an electronic application from participants in the turnover of certain types of medical devices registered in the providing remote access to the issue registration device.

6. To establish that on the territory of the Russian Federation, the introduction into circulation of certain types of medical products without drawing on consumer packaging, including by drawing on such consumer packaging a label containing an identification tool, certain types of medical products and without submitting information on labeling certain types of medical products with identification tools to the monitoring information system is allowed until the dates established by sub items " a " and "e" of item 3 of this resolution, from which the application of identification tools on consumer packaging, including by applying a label containing the identification tool on such consumer packaging, such individual types of medical products and submitting information to the information monitoring system become mandatory, except for the cases specified in the Document. in the first paragraph of sub item " d "and the first paragraph of sub item" i " of item 3 of this resolution.

(ed. Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

Turnover and withdrawal from circulation of unmarked individual types of medical products manufactured in the Russian Federation or imported (imported) into the Russian Federation in the case of importation from the territory of the Eurasian Economic Union in the framework of cross-border trade or release by customs authorities when they are placed under customs procedures for release for domestic consumption or re-import of unmarked individual types of medical products (in the case of production outside the Russian Federation), are allowed until the expiration date 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 paragraph four of sub item "d" and paragraph one of sub item "i" of item 3 of this resolution).

(ed. Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

It is allowed for the customs authorities to issue certain types of medical products that are imported (imported) unmarked and placed under customs procedures for release for domestic consumption or re-import, specified in sub items " d " and " h " of item 3 of this resolution:

(ed. Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

in respect of decontaminators-air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air), orthopedic shoes and removable corrective elements for orthopedic shoes (including insoles, half-soles) until October 31, 2023 (inclusive);

with respect to hearing aids, except for parts and accessories, coronary stents, computed tomographs, sanitary and hygienic products used for incontinence, until March 31, 2024 (inclusive);

for medical gloves until March 31, 2025 (inclusive).

(the paragraph was introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

7. This resolution does not apply to certain types of medical devices that, in accordance with the Rules approved by this resolution and international treaties of the Russian Federation, are not subject to the requirements for mandatory labeling by means of identification.

8. To establish that from October 1, 2023, the provision of marking codes necessary for the formation of identification tools to participants in the turnover of certain types of medical products is 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, upon the decision of a participant in the turnover of certain types of medical devices, the provision of marking codes necessary for the formation of identification tools may be carried out by the operator of the information monitoring system until the relevant date established by paragraph 3 of this resolution, from which the application of identification tools on consumer packaging of certain types of medical devices becomes mandatory. Such marking codes are provided free of charge by the operator of the monitoring information system. At the same time, a participant in the turnover of certain types of medical devices who has received marking codes free of charge ensures their conversion into identification tools and submits to the monitoring information system a report on the application of identification tools and information on the introduction of certain types of medical devices into circulation until September 30, 2023 (inclusive).

The service for providing the marking code in the case provided for in the first paragraph of this paragraph is considered to be provided by the operator of the information monitoring system at the time when the operator of the information monitoring system enters into the information monitoring system information about the introduction of certain types of medical devices into circulation, indicated by the participant in the turnover of certain types of medical devices in the notification of the introduction of the corresponding individual types of medical devices into circulation.

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

If a participant in the turnover of certain types of medical devices who has received marking codes free of charge has not ensured their conversion into identification tools and has not submitted to the monitoring information system a report on the application of identification tools and information on the introduction into circulation of certain types of medical devices by September 30, 2023 (inclusive), such marking codes are paid for by the participant turnover of certain types of medical devices or are canceled in accordance with the Rules approved by this resolution.

10. The application of identification means on consumer packaging of certain types of medical products, including by applying a label containing the identification means on such consumer packaging, does not require changes to the documents contained in the registration dossier for a medical product, in accordance with the procedure established by paragraphs 37-51 of the Rules for State Registration of Medical Products approved by the Government resolution Of the Russian Federation No. 1416 of December 27, 2012 "On Approval of the Rules for State Registration of Medical Devices".

11. This resolution comes into force on September 1, 2023.

 

Chairman of the Government

Of the Russian Federation

M. MISHUSTIN

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Approved

by Government Resolution

Of the Russian Federation

dated May 31, 2023 N 894

 

THE RULES

LABELING OF CERTAIN TYPES OF MEDICAL DEVICES

IDENTIFICATION TOOLS

 

I. General provisions

1. These Rules define the procedure for labeling certain types of medical products that are subject to mandatory labeling by means of identification, requirements for participants in the turnover of certain types of medical products, the procedure for information exchange of participants in the turnover of certain types of medical products with the state information system for monitoring the turnover of goods that are subject to mandatory labeling by means of identification (hereinafter referred to as the information monitoring system), the characteristics of the product identification, as well as the procedure for submission of information by participants in the turnover of certain types of medical devices to the monitoring information system on the entry into circulation, turnover and withdrawal from circulation of certain types of medical devices.

2. The terms used in these Rules mean the following:

"aggregation" means the process of combining goods in consumer packages into a group package, or into a set, or into transport packaging, or group packages into transport packaging, or sets into transport packaging, or transport packages into transport packaging of a higher level of nesting, while preserving information about the relationship of identification codes for each nested unit of goods in consumer packaging with the identification code of the created group package and (or) transport package, or with the identification code of the created set and (or) transport package, the relationship of the identification codes of each nested group package with the identification code of the created transport package, or the identification codes of each nested set with the identification code of the created transport package, as well as the relationship of the identification codes of each nested transport package packages with the identification code of the created transport package of a higher level of nesting and applying the appropriate identification tool to the group package or set, or the identification code of the transport package in order to ensure traceability of the movement of goods along the distribution chain without the need to open the created group and / or transport package or set and /or transport package;

"aggregated customs code" - a unique sequence of symbols for each individual set of goods, which is a combination of identification codes, including identification codes of packaging that combines goods in the aggregation process, formed by the operator of the information monitoring system for the purpose of identifying goods in accordance with these Rules, used by a participant in the turnover of goods during customs declaration of goods. At the same time, it is not allowed to combine identification codes of goods, some of which are already included in the identification code of a group or transport package, or in another aggregated customs code.

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

"putting goods into circulation":

when manufacturing goods on the territory of the Russian Federation (including in cases of contract production), 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, - sending a notification by a participant in the turnover of goods to the monitoring information system about the initial paid or gratuitous transfer goods from the manufacturer to a new owner or other person for the purpose of their alienation to such a person or subsequent sale (sale, including retail), which makes the goods available for distribution and (or) use, or sending a notification to the monitoring information system about the introduction of goods into circulation by the manufacturer or a third-party manufacturer of goods with submission to the information system monitoring of information in accordance with paragraph 77 of these Rules;

in the case of production of goods outside the territory of the Russian Federation ( except for goods imported from the member states of the Eurasian Economic Union) - the release by customs authorities of goods imported (imported) into the Russian Federation, in accordance with the customs procedures for release for domestic consumption or re-import, and the sending of a notification by a participant in the turnover of goods to turnover in accordance with paragraph 78 of these Rules;

in the case of production of goods outside the territory of the Russian Federation in respect of goods imported from the member states of the Eurasian Economic Union within the framework of cross-border trade in the customs territory of the Eurasian Economic Union, - import into the Russian Federation by a participant in the turnover of goods and sending to the monitoring information system by a participant in the turnover of goods a notification of the entry of goods into circulation with the submission of information to the monitoring information system in accordance with paragraph 81 of these Rules;

paid or gratuitous transfer to a new owner of goods acquired by participants in the turnover of goods in accordance with the established procedure during the sale of property, based on the results of auctions held in the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in administrative or criminal proceedings, as well as based on the results of the sale of property converted into the property of the Russian Federation in accordance with the legislation of the Russian Federation, sending a notification to the information system for monitoring the turnover of goods by a participant on the introduction of goods into circulation in accordance with paragraph 86 of these Rules;

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

paid or gratuitous transfer by participants in the turnover of goods to a new owner of goods previously purchased by them for purposes not related to their subsequent sale (sale) (for their own needs, production purposes, use in marketing campaigns on the territory of the Russian Federation, use in the framework of charitable activities) (hereinafter - purposes not related to their subsequent sale (sale)). implementation (sale), and sending a notification to the information system for monitoring the turnover of goods by the participant on the introduction of goods into circulation in accordance with paragraph 116 of these Rules;

sale (sale) of the remaining goods that were not sold as of October 1, 2023 by a participant in the turnover of goods within the framework of transactions involving the transfer of ownership of these goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contract agreements, and (or) assignment agreements, and sending them to an information system for monitoring notifications about the entry of goods into circulation by a participant in the turnover of goods in accordance with paragraph 117 of these Rules;

"withdrawal of goods from circulation":

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

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

sale of marked goods outside the Russian Federation;

sale (sale) of goods under a transaction, information about which is a state secret;

realization (sale) of goods by selling them according to samples or remotely when goods are shipped from a storage warehouse for delivery to the consumer;

use of goods for purposes unrelated to their subsequent sale.

offer to sell (sell) goods via a vending machine or postamate when goods are shipped from a storage warehouse for delivery to a vending machine or postamate;

delivery of marked goods within the framework of execution of contracts concluded in accordance with the Federal Law "On the Contract System for procurement of Goods, Works, and services for State and Municipal Needs "(hereinafter referred to as the Federal Law on the Contract System), except for the delivery of marked goods to participants in the turnover of goods that purchase such goods not for retail sale, a for carrying out activities in the field of health care and providing social and medical services;

"group packaging" means a package marked with an identification tool that combines a certain number of goods in consumer packages with a single product code, marked with identification tools, which can be disbanded or sold to the consumer in an unchanged form;

"importer" means a legal entity, a branch of a foreign legal entity, or an individual entrepreneur that imports goods into the Russian Federation, except in 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 product unit (a product in a consumer package, or a group package, or a set). based on the product code.

"electronic interaction interface" - a set of tools and rules that ensure the interaction of software and hardware of participants in the turnover of goods and an information monitoring system;

"corrected universal transfer document" - an electronic primary document on the shipment of goods (on the performance of works, on the provision of services), on the transfer of property rights, created by participants in the turnover of goods when correcting a document previously drawn up by participants in the turnover of goods that contained errors;

"group package identification code" - a sequence of symbols representing the unique number of a group package, formed for the purposes of identifying goods in a group package in accordance with the requirements provided for in section V of these Rules;

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

"transport package identification code" - a sequence of symbols representing a unique transport package number, formed in accordance with section V of these Rules;

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

"marked goods" - goods on which consumer packaging, including by applying a label containing identification means to such consumer packaging, identification means are applied in compliance with the requirements of these Rules and reliable information about which (including information about those applied to consumer packaging, including by applying labels to such consumer packaging containing the means of identification of the specified goods, means of identification) are contained in the monitoring information system;

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

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

"monitoring information system operator" means a legal entity registered on the territory of the Russian Federation that creates, develops, modernizes and operates the monitoring information system, ensures its uninterrupted operation, and receives, stores and processes information;

"operator of the national marking information system" means the competent (authorized) bodies of the member States of the Eurasian Economic Union, which include the 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 turnover of goods, and (or) interdepartmental coordination of the activities of executive authorities control over the turnover of goods, and (or) functioning of the national component of the information system for marking goods by means of identification, and (or) coordination of activities to ensure its functioning, as well as private operators authorized by the specified competent (authorized) bodies of the member States of the Eurasian Economic Union;

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

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

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

"offer of goods for sale (sale)" - provision by the seller of goods (samples of goods) to the buyer for direct acquaintance, including by displaying them at the place of sale (sale). It is not an offer for sale (sale) that the seller provides the buyer with a description of the product when selling remotely, which is contained in catalogues, brochures, booklets or is presented on photographs, or using postal and telecommunication networks, including the Internet information and telecommunications network (hereinafter referred to as the Internet). as well as communication networks for broadcasting TV channels and (or) radio channels, or in other ways that exclude the possibility of direct acquaintance of the buyer with the product or a sample of the product when concluding a purchase and sale agreement;

"producer" means a legal entity, or a branch of a foreign legal entity, or an individual entrepreneur who is a tax resident of the Russian Federation and who carries out the production and sale (sale) of goods on the territory of the Russian Federation;

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

"service provider" - a legal entity that performs, on behalf of a participant in the turnover of goods, the transformation of the marking code into an identification tool and (or) applying the identification tool to consumer packaging, and (or) group packaging, and (or) a set, and (or) a label;

"means of identification" - a marking code in machine-readable form, presented in the form of a bar code, formed in accordance with sections V and VI of these Rules, for application on consumer packaging, and (or) group packaging, and (or) a set, and (or) a label;

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

"third-party producer of goods" means a legal entity, or a branch of a foreign legal entity, or an individual entrepreneur who is a tax resident of the Russian Federation, who carries out the production and transfer of goods to the manufacturer within the framework of contract production;

"goods" - certain types of medical devices has a current registration certificate, part of the decontamination systems - air purifiers (including equipment, installations and bactericidal recirculators used for filtering and cleaning indoor air), orthopedic shoes and loose-corrective elements for shoes orthopedic (including insoles, polystelic), of hearing AIDS, excluding parts and accessories, coronary stents, CT scanners, sanitary and hygiene products used for incontinence, medical gloves, codes listed in the single 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, 000 0 20 9018, 9021 10 100 0, 9021 40 000 0, 1 900 90 9021, 9022 12 000 0, 9022 13 000 0, 000 0 9022 14, 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 codes of medical products 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 package" means a transport package that combines goods in consumer packages, and (or) group packages, and (or) sets, used for storing and transporting goods in order to protect them from damage during movement and forming an independent transport unit. Transport packages may include smaller transport packages (volumes). At the same time, packaging that combines only goods in consumer packaging, and (or) group packaging, and (or) sets, is recognized as transport packaging of the first level, and subsequent transport packages of varying degrees of nesting, starting with packages containing only transport packages of the first level, are recognized as transport packages of the subsequent (second, third, etc.) level. level.

"notification of the introduction of goods into circulation" - an electronic document formed by a participant in the turnover of goods in the information monitoring system and containing the information specified in the paragraphs 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 change the value of goods shipped (works 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 fees;

"universal transfer document" - an electronic primary document on the shipment of goods (on the performance of works, on the provision of services), on the transfer of property rights, the format of which is approved by the federal executive body authorized for control and supervision in the field of taxes and fees;

"participants in the turnover of goods" - legal entities and individual entrepreneurs, as well as branches of foreign legal entities that are tax residents of the Russian Federation, which enter goods into circulation, turnover and (or) withdraw goods from circulation, with the exception of legal entities, individual entrepreneurs and branches of foreign legal entities:

purchasing goods for use for purposes not related to their subsequent sale (sale) (except in cases when importers import goods into the Russian Federation, as well as purchase goods for use in carrying out activities in the field of healthcare and providing social and medical services);

when selling goods based on samples or remotely, they provide postal communication services in relation to cash-on-delivery items, or delivery services for goods to consumers, or act as payment agents that do not sell marked goods (the exception does not apply to legal entities, branches of foreign legal entities, and individual entrepreneurs, including owners of aggregators of information about the state of the Russian Federation). goods (services), when they provide a set of services for warehouse storage, picking and (or) packaging in relation to one unit of goods, including with the involvement of third parties);

purchasing or selling (selling) goods under a transaction, information about which is a state secret (except for persons withdrawing goods from circulation under such transactions);

"label" means an information carrier intended for displaying product information and (or) identification tools, attached directly to consumer packaging, and (or) group packaging, and (or) kit packaging, including by gluing.

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

3. These Rules, in addition to the cases provided for in paragraph 3 of the Rules for Marking Goods Subject to mandatory marking by means of identification, approved by Decree of the Government of the Russian Federation No. 515 of April 26, 2019 "On the system for marking goods by means of identification and Traceability of Movement of Goods" (hereinafter referred to as the Rules for Marking Goods), do not apply to:

a) goods placed under customs procedures for 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 turnover of goods as advertising, marketing samples that are not intended for sale (sale);

c) goods purchased under a transaction, information about which is a state secret, when they are transported by a participant in such a transaction on the territory of the Russian Federation;

d) goods that are not subject to state registration on the basis of part 5 of Article 38 of the Federal Law "On the basics of public health protection in the Russian Federation".

4. The operator of the monitoring information system has the right to provide marking codes to operators of national marking information systems. Marking codes should be used by participants in the turnover of goods of the member States of the Eurasian Economic Union for marking by means of identification of goods imported into the Russian Federation.

Obtaining marking codes by operators of national marking information systems is carried out by exchanging information with the operator of the monitoring information system in accordance with the procedure established by the Decision of the Board of the Eurasian Economic Commission No. 100 of July 13, 2022.

In order to obtain marking codes, operators of national marking information systems enter into a contract with the operator of the monitoring information system for the provision of marking codes.

5. The following statuses of identification code, group package identification code, set identification code, transport package identification code, aggregated customs code are possible in the monitoring information system:

a) for identification code, group package identification code, set identification code:

"issued" - the identification code as part of the marking code is provided by the operator of the information monitoring system to the participant in the turnover of goods for the purpose of marking goods with identification tools, the corresponding product is not put into circulation;

"in circulation" - identification code as part of the marking code provided by the operator of the information monitoring system to the participant in the turnover of goods, the corresponding product is marked with identification means, put into circulation and is in circulation.

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

"retired" - the identification code in the marking code has been withdrawn from circulation, the corresponding product has been withdrawn from circulation.

b) for the transport package identification code, aggregated customs code:

"formed" - is assigned automatically after the participant submits information about the turnover of goods with the described composition of the transport package identification code, aggregated customs code.

"disbanded" - is assigned automatically in the process of complete disbanding of the transport package composition, aggregated customs code.

6. Marking of goods by means of identification is carried out taking into account the requirements for the safety of goods.

 

II. Requirements for participants in the turnover of goods,

the procedure for their registration in the monitoring information system.

Requirements for service providers

 

7. Participants in the turnover of goods must:

a) possess a qualified certificate of the electronic signature verification key corresponding to the electronic signature key that allows you to create an enhanced qualified electronic signature (hereinafter referred to as an enhanced electronic signature);

b) have a software and hardware complex that has the ability to generate and sign electronic documents with an enhanced electronic signature, as well as exchange the necessary electronic documents with the monitoring information system, including through the personal account;

c) have remote access to the emission registration device located in the infrastructure of the information monitoring system (for participants in the turnover of goods that carry out labeling and (or) relabeling of goods in accordance with the requirements of these Rules);

d) have a contract concluded with the electronic document management operator (for participants in the turnover of goods who transfer the information provided for in these Rules in accordance with paragraph 23 of these Rules).

(item 7 as amended. Decree of the Government of the Russian Federation No. 743 of 31.05.2024)

8. A participant in the turnover of goods engaged in trading using cash registers (including commission trading in cases stipulated by the Federal Law "On the Fundamentals of State Regulation of Trading Activities in the Russian Federation"), in addition to the requirements provided for in paragraph 7 of these Rules, must have:

a) software and (or) technical means of recognition of identification devices associated with cash registers;

b) an agreement 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 a permit for processing fiscal data in accordance with the legislation of the Russian Federation on the use of cash registers (hereinafter referred to as the fiscal data operator), an agreement for processing and transferring goods to the information monitoring system on behalf of a participant in the turnover of goods information on the turnover of goods if the transaction is carried out between participants in the turnover of goods registered in the monitoring information system, or on the withdrawal of marked goods from circulation using cash registers for each sold commodity unit (except for the transfer of information on the withdrawal of marked goods from circulation in cases where cash registers are used in the not providing for mandatory transfer of fiscal documents to the tax authorities in electronic form through the fiscal data operator).

9. Remote access to the emission registration device located in the infrastructure of the monitoring information system is provided by the operator of the monitoring information system on a free-of-charge basis.

10. Service providers must have a set of printing equipment with a capacity sufficient for converting and applying identification tools on behalf of a participant in the turnover of goods, but not lower than regularly placed orders for the production of consumer packaging and labels from a participant in the turnover of goods, and ensuring the application of symbols of marking codes not lower than class 2.5 (B) in accordance with national standard of the Russian Federation GOST R ISO / IEC 15415-2012 " Information technologies. Technologies for automatic identification and data collection. Specification of bar code character tests for evaluating print quality. Two-dimensional symbols", approved by Order No. 357-st of the Federal Agency for Technical Regulation and Metrology of September 18, 2012 and entered into force on July 1, 2013 (hereinafter referred to as the national standard of the Russian Federation GOST R ISO / IEC 15415-2012).

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

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

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

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

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

e) hardware (with the use of technical vision) validation of the identification tool;

f) deleting the verification code after validation of the identification tool and generating information about the application and validation of the identification tool;

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

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

i) sending information about the validation of identification tools to the turnover participant.

12. The Service provider provides:

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

b) formation of information on the application and (or) validation of the identification tool and their submission to the participant in the turnover of goods;

c) compliance with the quality standards of printing identification tools and validation of the identification tool before transferring consumer packaging, or group packaging, or a set, or a label with the identification tool applied to the participant in the turnover of goods.

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

14. In order to obtain the specified software and hardware package for the distribution of marking codes, service providers enter into contracts with the operator of the information monitoring system.

15. Registration of a participant in the turnover of goods in the monitoring information system is carried out on the basis of an application of a participant in the turnover of goods sent to the monitoring information system and signed with an enhanced electronic signature of the participant in the turnover of goods.

(ed. Decree of the Government of the Russian Federation No. 743 of 31.05.2024)

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

a) the surname, first name, patronymic (if any) of the person who has the right to act on behalf of the participant in the turnover of goods without a power of attorney;

b) phone number and e-mail address of the participant in the turnover of goods to which notifications will be sent from the information monitoring system.

17. An applicant-a branch of a foreign legal entity, in addition to the grounds provided for in paragraph 17 of the Rules for Marking Goods (excluding the grounds provided for in subparagraph "d" of this paragraph), is refused registration in the monitoring information system in case of non-compliance of the information regarding the applicant specified in the registration application with the information specified in the state register of accredited branches, representative offices of foreign legal entities, as well as in the absence of an entry on the applicant in the specified register or the presence of an entry on the termination of its accreditation.

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

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

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

c) types of documents submitted to the monitoring information system, the right to sign which is granted to the authorized person;

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

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

19. In case of termination of the powers of an authorized person, the person entitled to act on behalf of a participant in the turnover of goods without a power of attorney enters information on the date of termination of the document confirming the powers of the authorized person into the monitoring information system.

20. In addition to the grounds for refusal provided for in paragraph 29 of these Rules, information about the authorized person is also refused to be entered into the monitoring information system if the authorized person is already registered in the monitoring information system as an authorized person of this participant in the turnover of goods.

21. A participant in the turnover of goods previously registered in the monitoring information system as a participant in the turnover of other goods subject to mandatory marking by means of identification, for registration as a participant in the turnover of goods, sends an appropriate notification to the monitoring information system containing the following information:

a) taxpayer identification number of the goods turnover participant;

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

c) the type of participant in the turnover of goods (one participant in the turnover of goods can belong to several types).

 

III. Procedure for information exchange of turnover participants

products with an information monitoring system

 

22. Participants in the turnover of goods submit information to the information monitoring system using standard data transfer protocols and electronic interaction interfaces developed by the operator of the information monitoring system by exchanging electronic documents (application, notification, receipt, etc.), the format of which is determined by the operator of the information monitoring system and posted on the official website of the operator of the information monitoring system "The Internet".

23. The obligation to submit to the information monitoring system the information provided for in these Rules, transmitted as part of universal transfer documents, corrected universal transfer documents, universal correction documents, is performed by a participant in the turnover of goods through an electronic document management operator on the basis of an agreement concluded between them, which should provide for the following:

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

b) the electronic document flow operator transfers notifications (receipts) of the information monitoring system operator specified in paragraph 30 of these Rules to the participant in the turnover of goods in real time;

c) the date of performance of the obligation of a participant in the turnover of goods to submit information to the monitoring information system is considered to be the date of receipt of the universal transfer document, corrected universal transfer document, universal correction document by the operator of the monitoring information system;

d) the responsibility for the correctness of information contained in universal transfer documents, corrected universal transfer documents and universal correction documents is borne by the participant in the turnover of goods, and the responsibility for the immutability and timeliness of transmission to the information monitoring system of universal transfer documents, corrected universal transfer documents, universal correction documents submitted by the participant in the turnover of goods is borne by the electronic document management operator.

24. Submission of information about a group package or set by a participant in the turnover of goods is equal to the submission of information about consumer packages contained in this group package or in this set, respectively, based on data from the information monitoring system. A participant in the turnover of goods independently aggregates labeled goods in consumer packages into a group package and (or) a set and submits information to the monitoring information system about identification codes that are part of the group package identification code and (or) the set identification code, respectively. It is not allowed to aggregate labeled goods in consumer packages into a group package and / or set, if they are already included in another group package and / or set.

25. Submission of information about transport packaging by a participant in the turnover of goods is equal to the submission of information about all (consumer, group, transport) packages or sets contained in this transport package based on the data of the information monitoring system. A participant in the turnover of goods independently aggregates labeled goods in consumer packages, and (or) group packages, and (or) transport packages, and (or) sets in transport packaging, and submits information to the monitoring information system about identification codes, and (or) identification codes for group packages, and (or) identification codes sets, and (or) transport package identification codes that are part of the transport package identification code. It is not allowed to aggregate labeled goods in consumer packages, and (or) group packages, and (or) transport packages, and (or) sets in transport packaging, if they are already included in another transport package.

26. Submission by a participant in the turnover of goods of information on the inclusion of consumer packages in a group package or set, or on the inclusion in the transport package of consumer packages, or group packages, or transport packages, or sets that, according to the monitoring information system, were previously included in another group package, or set, or transport package, this is the basis for reflecting in the monitoring information system the fact of disbanding previously created group packages, or sets, and (or) transport packages that included these packages.

27. The submission of information on aggregated customs codes by a participant in the turnover of goods is equivalent to the submission of information on identification codes, identification codes for sets, identification codes for group packages of goods imported (imported) into the customs territory of the Eurasian Economic Union, contained in the aggregated customs code based on data from the information monitoring system.

28. Starting from October 1, 2023, participants in the turnover of goods submit to the monitoring information system information on identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages when decontaminating air purifiers (including equipment that is used in the production process) are put into circulation. bactericidal installations and recirculators used for filtering and purifying indoor air), orthopedic shoes and removable corrective elements for orthopedic shoes (including insoles, half-soles).

Starting from March 1, 2024, participants in the turnover of goods submit to the monitoring information system information on identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages when introducing hearing aids into circulation, except for parts and accessories, coronary stents, and computer devices tomographs, sanitary and hygienic products used for incontinence.

At the same time, information within the framework of transactions involving 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) contract agreements, and (or) assignment agreements, is not transmitted to the monitoring information system until August 31, 2025 (inclusive). With regard to sanitary and hygienic products used for incontinence, information in the framework of transactions involving the transfer of ownership of these goods, as well as in the framework of commission agreements, and (or) agency agreements, and (or) contract agreements, and (or) assignment agreements are not transmitted to the monitoring information system until February 28 2026 (inclusive).

(ed. Decree of the Government of the Russian Federation No. 1409 of 12.09.2025)

Starting from September 1, 2024, participants in the turnover of goods, in addition to the information provided for in paragraphs one and two of this paragraph, submit to the monitoring information system information on identification codes, and (or) identification codes for group packages, and (or) identification codes for sets when they are withdrawn from circulation.

Starting from March 1, 2025, participants in the turnover of goods submit to the monitoring information system information on identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages when entering into circulation and withdrawing medical gloves from circulation. With regard to medical gloves, information in the framework of transactions involving the transfer of ownership of these goods, as well as in the framework of commission agreements, and (or) agency agreements, and (or) contract agreements, and (or) assignment agreements are not transmitted to the monitoring information system until February 28, 2026 (inclusive).

(the paragraph was introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024; as amended by the Government of the Russian Federation. Decree of the Government of the Russian Federation No. 1409 of 12.09.2025)

Starting from September 1, 2025, participants in the turnover of goods submit to the monitoring information system information on identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages in relation to goods put into circulation from September 1, 2025, as when entering goods in the context of transactions involving the transfer of ownership of these goods, as well as in the context of commission agreements, agency agreements, and / or contract agreements, and / or assignment agreements.

(ed. Decree of the Government of the Russian Federation No. 1409 of 12.09.2025)

From March 1, 2026, participants in the turnover of goods in relation to sanitary and hygienic products used for incontinence and medical gloves put into circulation from March 1, 2026, submit to the monitoring information system information on identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes of transport packages both when goods are put into circulation and goods are withdrawn from circulation, and in the framework of transactions involving the transfer of ownership of such goods, as well as in the framework of commission agreements, and (or) agency agreements, and (or) contract agreements, and (or) assignment agreements.

(the paragraph was introduced by Decree of the Government of the Russian Federation No. 1409 of 12.09.2025)

29. The operator of the information monitoring system refuses to accept documents (applications, notifications) or to enter into the information monitoring system information submitted by participants in the turnover of goods to the information monitoring system, if there is one of the following grounds:

a) the submitted documents are 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 signed by a person who is not authorized by the participant in the turnover of goods to sign the document on behalf of the participant in the turnover of goods or who does not have the right to sign this type of document;

c) the presence of an entry in the unified state register of legal entities on the termination of the activity of a legal entity, or an entry in the unified state register of individual entrepreneurs on the termination of an individual's activity as an individual entrepreneur, or an entry 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) non-access to the monitoring information system of the information specified in paragraph 83 of these Rules, requested in the Unified Automated Information System of Customs Authorities or in customs authorities in any other way provided for by the agreement on information interaction.

30. A participant in the turnover of goods is notified of receiving the submitted electronic documents, or of entering information into the monitoring information system, or of refusing to accept electronic documents, or of refusing to enter information into the monitoring information system by sending him a notification (receipt) of receiving electronic documents, or of entering information into the monitoring information system, or refusal to accept electronic documents, or refusal to enter information in the monitoring information system containing the following information:

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

b) the number of the notification (receipt);

c) date of notification (receipt);

d) identification codes, identification codes for group packages, identification codes for sets, identification codes for transport packages, aggregated customs codes (in the case of production of goods outside the territory of the Russian Federation and imported (imported) into the customs territory of the Eurasian Economic Union) and their status (change of status) in the monitoring information system (if submitted by the turnover participant the document contains information about operations performed with goods).

e) notification of receipt or entry of documents (information) in 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 turnover of goods to the information monitoring system in accordance with paragraph 22 of these Rules (except for an application for registration of a participant in the turnover of goods, an application for testing information interaction, an application for access to an issue registration device) may be signed with an enhanced electronic signature of this participant in the turnover of goods, which performs the functions of the operator of the corresponding information system, using electronic signature tools used for automatic creation of electronic signatures.

(item 30 (1) was introduced by Decree of the Government of the Russian Federation No. 743 of 31.05.2024)

31. Notifications (receipts) specified in clause 30 of these Rules are 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 turnover of goods using electronic interaction interfaces through the personal account in the monitoring information system or by e-mail within one calendar day from the date of submission of documents by the participant in the turnover of goods or information sent to the monitoring information system.

32. The fact that a participant in the turnover of goods fulfills the obligation to submit electronic documents (information) to the monitoring information system is confirmed by a notification (receipt) on entering electronic documents (information) into the monitoring information system.

The date of submission of electronic documents (information) to the information monitoring system by a participant in the turnover of goods is the date specified in the notification (receipt) of acceptance of electronic documents (receipt of information).

These notifications (receipts) are automatically generated, signed with an enhanced electronic signature of the operator of the monitoring information system using electronic signature tools used for automatic creation of electronic signatures, and sent to the participant in the turnover of goods through the monitoring information system in the form of an electronic document when placing the transferred documents (information) in the monitoring information system.

33. The obligation to submit to the information monitoring system the information provided for in these Rules for the delivery of marked goods in 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 turnover of goods by submitting acceptance documents provided for in Part 13 of Article 94 of the Federal Law on the Contract System (hereinafter referred to as acceptance documents), to the unified procurement information system (hereinafter referred to as the procurement information system).

Information interaction of the monitoring information system and the procurement information system is carried out in accordance with the agreement on information interaction. Notifications (receipts) of the operator of the information monitoring system specified in clause of these Rules, if information is transmitted in accordance with this clause, are transmitted by the operator of the information monitoring system to participants in the turnover of goods to the federal executive body responsible for creating, developing, maintaining and servicing the information procurement system (hereinafter referred to as the information procurement system operator).

The operator of the procurement information system provides:

transfer of acceptance documents signed by both parties to the contract to the monitoring information system within 2 hours from the moment when the recipient of goods signs the acceptance document in the procurement information system and places it in the procurement information system, as well as informing the participant in the turnover of goods about the results of the transfer;

transfer of notifications (receipts) of the monitoring information system operator specified in paragraph of these Rules to participants in the turnover of goods within 2 hours from the moment when the recipient of goods signs the acceptance document in the procurement information system and places it in the procurement information system, provided that such notifications (receipts) are received from the monitoring information system operator.

If the acceptance document is sent via the operator of the procurement information system:

the date of fulfillment of the obligation of a participant in the turnover of goods to submit information to the monitoring information system is considered to be the date of receipt of the acceptance document by the operator of the monitoring information system;

the participant of the goods turnover is responsible for the correctness of the information contained in the acceptance documents, corrected acceptance documents, and the operator of the procurement information system is responsible for the immutability and timely transmission of acceptance documents, corrected acceptance documents submitted by the participant of the goods turnover to the information monitoring system.

34. The obligation to submit to the information monitoring system the information provided for in these Rules, in the case of centralized delivery and withdrawal of marked goods from circulation in the framework of the execution of contracts concluded in accordance with the Federal Law on the Contract System, is performed by a participant in the turnover of goods engaged in activities in the field of health, in accordance with the procedure provided for in paragraph 23 of these Rules.

35. Participants in the turnover of goods submit information to the information monitoring system both independently and with the involvement of other legal entities or individual entrepreneurs authorized by participants in the turnover of goods and acting on their behalf in accordance with the legislation of the Russian Federation.

The operator of the information monitoring system ensures placement of documents and information submitted by a participant in the turnover of goods in the information monitoring system within one calendar day from the date of receipt of such documents and information, with the mandatory sending of a notification (receipt) on making changes to the information monitoring system to the applicant, as well as to other participants in goods, if such changes affect their interests.

 

IV. Registration of goods in the information monitoring system

 

36. Registration of goods is carried out by participants in the turnover of goods in the subsystem of the national catalog of marked goods on the basis of the submitted application for registration of goods:

a) when producing goods on the territory of the Russian Federation-by producers (including cases of contract production);

b) when producing goods outside the territory of the Russian Federation, including goods imported from the member states of the Eurasian Economic Union within the framework of cross-border trade in the customs territory of the Eurasian Economic Union, by the importer;

c) in the case of sale (sale) of goods previously acquired under a transaction, information about which constitutes a state secret, - a participant in the turnover of goods who purchased the goods and made a decision on its further sale (sale) under a transaction, information about which does not constitute a state secret;

d) when goods are returned by a consumer in accordance with the legislation of the Russian Federation on consumer rights protection on the territory of the Russian Federation - a participant in the turnover of goods that is a retail organization;

e) when goods purchased by participants in the turnover of goods for purposes not related to their subsequent sale (sale) are returned to circulation, a participant in the turnover of goods returning the goods to circulation;

f) when purchasing goods for the purpose of further sale (sale), based on the results of auctions held in the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in administrative and criminal proceedings, as well as based on the results of the sale of property converted into the property of the Russian Federation in accordance with the legislation of the Russian Federation, - a participant in the turnover of goods, who purchased these products.

g) in the presence of goods unmarked by means of identification that are in circulation as of the start date of mandatory labeling of goods (remnants of goods), - a participant in the turnover of goods that carries out the turnover of these goods;

h) when forming sets - a participant in the turnover of goods before the sale (sale) of such sets to third parties, including before their display at the place of sale (sale), demonstration of their samples.

37. For registration of decontaminizers - air purifiers (including equipment, bactericidal installations and recirculators used for filtering and purifying indoor air), hearing aids and computed tomographs in the subsystem of the national catalog of labeled goods, a participant in the turnover of goods submits the following information about the registered product:

a) the applicant's taxpayer identification number;

b) product code (if available);

c) the full name of the product;

d) trademark (if any);

e) 10-digit code of the product nomenclature;

f) code of the country of production in accordance with the All-Russian classifier of countries of the world;

g) the type of product;

h) model (article number) of the manufacturer;

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

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

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

38. For registration of orthopedic shoes in the subsystem of the national catalog of marked goods, a participant in the turnover of goods submits the following information about the registered product:

a) the applicant's taxpayer identification number;

b) product code (if available);

c) the full name of the product;

d) trademark (if any);

e) 10-digit code of the product nomenclature;

f) code of the country of production in accordance with the All-Russian classifier of countries of the world;

g) product category;

h) type of shoes;

i) the size in the stihmass system;

k) color.

l) upper material;

m) lining material;

h) material of the bottom (sole);

o) model (article number) of the manufacturer;

p) functional purpose;

p) medical appointment according to the degree of severity of the violation of stat dynamic function;

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

t) number and date of the declaration of conformity (if any);

y) expiration date or service life, number of months (for the service life).

39. For registration of additional corrective elements for orthopedic footwear (including insoles, half-soles) in the subsystem of the national catalog of marked goods, a participant in the turnover of goods submits the following information about the registered product:

a) the applicant's taxpayer identification number;

b) product code (if available);

c) the full name of the product;

d) trademark (if any);

e) 10-digit code of the product nomenclature;

f) code of the country of production in accordance with the All-Russian classifier of countries of the world;

g) product category;

h) the type of product;

i) functional purpose;

j) the method of use;

k) composition;

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

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

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

40. For registration of coronary stents in the subsystem of the national catalog of labeled goods, a participant in the turnover of goods submits the following information about the registered product:

a) the applicant's taxpayer identification number;

b) product code (if available);

c) the full name of the product;

d) trademark (if any);

e) 10-digit code of the product nomenclature;

f) code of the country of production in accordance with the All-Russian classifier of countries of the world;

g) the type of product;

h) model (article number) of the manufacturer;

i) the length of the stent;

k) free external diameter of the stent;

l) the type of stent construction;

m) stent frame material;

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

o) number and date of the declaration of conformity (if any);

n) expiration date or service life, number of months (for the service life).

41. For registration of sanitary and hygienic products used for incontinence in the subsystem of the national catalog of labeled goods, a participant in the turnover of goods submits the following information about the registered product:

a) the applicant's taxpayer identification number;

b) product code (if available);

c) the full name of the product;

d) trademark (if any);

e) 10-digit code of the product nomenclature;

f) code of the country of production in accordance with the All-Russian classifier of countries of the world;

g) product category;

h) the type of product;

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

k) absorption capacity (moisture absorption);

k) composition;

m) waist (hip) circumference (in terms of adult diapers);

h) the size of the product (in terms of adult absorbent diapers);

o) target gender (in terms of urological pads and liners);

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

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

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

41(1). To register medical gloves in the subsystem of the national catalog of marked goods, a participant in the turnover of goods submits the following information about the registered product:

a) the applicant's taxpayer identification number;

b) product code (if available);

c) the full name of the product;

d) trademark (if any);

e) 10-digit code of the product nomenclature;

f) code of the country of production in accordance with the All-Russian classifier of countries of the world;

g) product category;

h) the type of product;

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

j) the size of the product;

k) composition;

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

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

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

(item 41 (1) was introduced by Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

42. To register a set in the subsystem of the national catalog of marked goods, a participant in the turnover of goods submits the following information:

a) the applicant's taxpayer identification number;

b) the product code for the kit (if any);

c) the full name of the kit;

d) trademark (if any);

e) 10-digit code of the product nomenclature (if any);

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

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

h) composition of the set (optional).

43. In addition to the information specified in paragraphs - 41(1) of these Rules, a participant in the turnover of goods may submit photo images of goods from different angles when registering goods.

(ed. Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

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

In addition to the grounds provided for in paragraph 29 of these Rules, the grounds for refusing to accept documents or enter information submitted by participants in the turnover of goods to the subsystem of the national catalog of marked goods into the subsystem of the national catalog of marked goods are the presence of one of the following grounds:

the information provided for in paragraphs 37, and (or) 38, and (or) 39, and (or) 40, and (or) 41, and (or) 41(1), and (or) 42 of these Rules is not provided;

(ed. Decree of the Government of the Russian Federation No. 860 of 26.06.2024)

the submitted information does not contain 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 tool, including

structure and format of marking codes, identification codes

and verification codes

 

45. The identification tool is applied as a two-dimensional bar code in Data Matrix format in accordance with the requirements of the national standard of the Russian Federation GOST R ISO / IEC 16022-2008 " Automatic identification. Bar code is used. Specification of Data Matrix symbols", approved by Order No. 509-st of the Federal Agency for Technical Regulation and Metrology of December 18, 2008 and entered into force on January 1, 2010 (hereinafter referred to as the national standard of the Russian Federation GOST R ISO / IEC 16022-2008), using the ECC 200 symbol and using FNC1 as a symbol feature (having the code 232 in the ASCII character table) and the data corresponds to the standard format of application identifiers (AI) GS1 in accordance with paragraph 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 transformation and quality of the application of identification tools:

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

b) the printing quality of the identification tool must meet the requirements of the national standard of the Russian Federation GOST R ISO / IEC 15415-2012, as well as when it is applied by a participant in the turnover of goods to the quality not lower than class 1.5 (C) in accordance with such a national standard;

c) the recommended size range for Data Matrix elements that make up a two-dimensional bar code is from 0.255 to 0.680 millimeters. The size of the identification tool must meet the requirements of the national standard of the Russian Federation GOST R ISO / IEC 16022-2008.

47. When converting marking codes into identification tools and marking goods, service providers and participants in the turnover of goods must ensure compliance with the printing quality standards of the identification tool specified in paragraphs 10 and 46 of these Rules.

48. When a participant in the turnover of goods attracts a service provider, the participant in the turnover of goods transfers marking codes to the service provider for conversion and application by means of a software and hardware complex for distributing marking codes provided by the operator of the monitoring information system to the service provider. After converting the marking code into a product identification and labeling tool, the service provider validates the identification tool before transferring consumer packaging, or group packaging, or a set, or a label with the applied identification tool to the participant in the turnover of goods. Information about the application and validation of identification tools is provided by service providers to the participant in the turnover of goods through the hardware and software package for the distribution of marking codes.

49. The printing equipment used for converting the identification tool must provide the required 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, and must meet the requirements of the national standard of the Russian Federation GOST R ISO / IEC 16022-2008 and ensure the quality of printing of the applied symbols of marking codes not lower than class 1.5 (C) at the final stage of the technological process of validation of the applied identification tools immediately before the shipment of the manufactured consumer package, or group package, or manufactured set, or label with identification tools applied to it to the participant in the turnover of goods that

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

51. The method of applying the identification tool must ensure the safety (stability) of the identification tool during the entire shelf life or service life of the product, subject to the storage and transportation conditions established by the manufacturer.

52. The service provider has the right to submit marking codes received from a participant in the turnover of goods only to another service provider. The transfer of marking codes is carried out in order to fulfill its obligations to such a participant in the turnover of goods in accordance with these Rules only using the software and hardware complex for the distribution of marking codes provided by the operator of the information monitoring system.

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

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

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

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

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

54. The transport package identification code is presented in the form of a bar code that meets the requirements of the interstate standard GOST ISO 15394-2013 " Packaging. Linear bar code symbols and two-dimensional symbols on labels for shipment, transportation, and acceptance. General Requirements", introduced on January 1, 2014 by Order No. 106-art. of the Federal Agency for Technical Regulation and Metrology of May 15, 2013. The composition of the transport package identification code is determined independently by the participant in the turnover of goods that aggregates goods into transport packaging.

The monitoring information system reflects information about the relationship between the identification codes of each nested product in consumer packaging, and (or) group packaging, and (or) set, and (or) transport packaging with the identification code of the transport package being created.

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

 

XXXXXXXXXXXXDDMMGGXXXXXXXX,

 

where:

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

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

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 declaration for goods, approved by the Decision of the Customs Union Commission of May 20, 2010 N 257 (when performing customs operations and releasing goods before filing the declaration for goods, taking into account the requirements for the application of information about goods, provided for by the Procedure for filling out the application on the release of goods prior to filing a declaration for goods, approved by the Decision of the Board of the Eurasian Economic Commission No. 171 of December 13, 2017).

(ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

56. Identification tools in bar code format must meet the following requirements:

a) the probability of guessing the identification tool should be negligible 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 of at least 0.255 mm in size.

57. The monitoring information system does not allow re-generation (generation) of the marking code contained in the identification tool.

 

VI. Procedure for creating identification tools

 

58. Within the framework of the processes specified in paragraphs 59 and 63 of these Rules, a participant in the turnover of goods exchanges electronic documents and information with the information monitoring system through an emission registration device.

59. To ensure the marking of goods, a participant in the turnover of goods sends an application for obtaining marking codes to the operator of the information monitoring system (hereinafter referred to as the application). The application form and format are approved by the operator of the information monitoring system.

60. To form an application, a participant in the turnover of goods sends the following information to the monitoring information system:

a) taxpayer identification number of the goods turnover participant;

b) method of entering the product into circulation:

produced on the territory of the Russian Federation;

imported into the Russian Federation;

relabeling.

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

sale (sale) of goods purchased earlier for purposes not related to their subsequent sale (sale);

sale (sale) of goods purchased for the purpose of further sale (sale) based on the results of auctions held in the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in administrative or criminal proceedings, as well as on the results of the sale of property converted into the property of the Russian Federation in accordance with the legislation of the Russian Federation;

marking of goods in circulation as of the start date of mandatory marking of goods (marking of remaining goods);

c) the number of requested marking codes;

d) the product code for which it is necessary to generate a marking code;

e) individual serial number of each item of goods, if it is formed by the participant in the turnover of goods independently;

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

g) taxpayer identification number of the service provider, if the goods are supposed to be marked using the services of the service provider.

61. The operator of the monitoring information system refuses to issue marking codes if one of the following requirements is violated:

a) the application does not meet the requirements of paragraph 60 of these Rules;

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

c) the monitoring information system does not contain information about the issue registration device used to send the application;

d) the identification codes specified in the application, or the identification codes of a group package, or the identification codes of a set are previously 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 monitoring information system tools, generates (generates) the number of marking codes specified in the application and enters the corresponding identification codes, or identification codes for group packages, or identification codes for sets in the monitoring information system.

63. After entering the identification codes specified in the application, or identification codes for group packages, or identification codes for sets into the monitoring information system, the monitoring information system operator sends information about the marking codes provided under the application to the emission registration device of the applicant by means of the monitoring information system.

64. In the case of self-marking of goods, after receiving the marking code, the participant in the turnover of goods converts it into an identification tool, ensures the marking of the goods, and within 30 calendar days from the date when the operator of the information monitoring system provides the participant in the turnover of goods with information about the marking codes provided upon request, transmits to the monitoring information system a report on the application of identification tools in the following composition:

identification number of the taxpayer participating in the turnover of goods;

a marking code converted into an identification tool applied to a consumer package, or group package, or set, or a label located on such consumer package, group package, or set;

date of production;

expiration date.

batch number and / or individual factory serial number.

The conversion of marking codes paid for by a participant in the turnover of goods before they are provided by the operator of the information monitoring system, and the application of identification tools converted from such marking codes, are carried out by the participant in the turnover of goods at its discretion, regardless of the time limit set by the first paragraph of this paragraph.

65. When the service provider applies identification tools, the marking codes are converted by the service provider into identification tools for applying to consumer packaging, group packaging, set or label, followed by validation of identification tools and transmission of information about the application and validation of identification tools to the participant in the turnover of goods through the software and hardware complex of distribution of marking codes. For the service provider to transmit marking codes, information on the application and validation of identification tools, a hardware and software package for the distribution of marking codes is used, provided by the operator of the monitoring information system.

66. After the production of goods marked by the service provider, the participant in the turnover of goods, within 365 calendar days from the date when the operator of the information monitoring system provides the participant in the turnover of goods with information on the marking codes provided upon request, submits to the information monitoring system a report on the application of identification means in the following composition:

identification number of the taxpayer participating in the turnover of goods;

a marking code converted into an identification tool applied to a consumer package, or group package, or set, or a label located on such consumer package, group package, or set;

date of production;

expiration date.

batch number and / or individual factory serial number.

The conversion of marking codes paid for by a participant in the turnover of goods before they are provided by the operator of the information monitoring system, and the application of identification tools converted from such marking codes, are carried out by the participant in the turnover of goods at its discretion, regardless of the time limit set by the first paragraph of this paragraph.

67. Payment for the service of providing a marking code provided for by the Decree of the Government of the Russian Federation No. 577 of May 8, 2019 "On Approval of the amount of payment for the provision of services for providing marking codes Necessary for Forming identification tools and ensuring monitoring of the movement of Goods Subject to mandatory marking by identification Tools, as well as on the Procedure for its collection", is made:

if the goods are marked by a participant in the turnover of goods independently-before the date when the operator of the information monitoring system provides the participant in the turnover of goods with information about the marking codes provided upon request, or within 30 calendar days from the specified date, but not later than the date when the marked product is put into circulation, the identification means of which is converted from the corresponding marking code;

if goods are marked by a service provider - before the date when the operator of the information monitoring system provides the participant in the turnover of goods with information about the marking codes provided upon request, or within 365 calendar days from the specified date, but not later than the date when the marked product is put into circulation, the identification tool of which is converted from the corresponding marking code.

At the same time, the operator of the monitoring information system enters into the monitoring information system information about the application of the identification tool, indicated by the participant in the turnover of goods in the report on the application of the identification tool, only after receiving payment for the service of providing the marking code converted into the corresponding identification tool.

The decision on the choice of payment method for providing the marking code is made by the participant in the turnover of goods.

If payment for the service of providing a marking code is made by a participant in the turnover of goods before the date when the operator of the information monitoring system provides the participant in the turnover of goods with information about the marking codes provided under the application, such service is recognized as provided by the operator of the information monitoring system at the time when the operator of the information monitoring system provides the participant in the turnover of goods with information about the marking codes provided under the application.

If payment for the service of providing a marking code is made by a participant in the turnover of goods after the date when the operator of the information monitoring system provides the participant in the turnover of goods with information about the marking codes provided upon request, such service is recognized as provided by the operator of the information monitoring system at the time when the operator of the information monitoring system enters the information system of monitoring information about the marking of goods specified by the participant in the turnover of goods in accordance with the request. report on the application of the identification tool.

68. If a participant in the turnover of goods who received marking codes on a gratuitous basis did not ensure their conversion into identification tools by September 30, 2023 (inclusive) and did not submit to the monitoring information system a report on the application of identification tools and information on the introduction of goods into circulation before the specified date, then from October 1, 2023. a participant in the turnover of goods has the right to put into circulation goods marked with identification means converted from such marking codes, subject to compliance with the deadline for sending a report on the application of identification means to the monitoring information system established by paragraphs 64 and (or) 66 of these Rules, and paying for the specified marking codes in accordance with this paragraph.

The service for providing the marking code in the case provided for in the first paragraph of this paragraph is recognized as provided by the operator of the information monitoring system at the time when the operator of the information monitoring system enters into the information monitoring system information about the introduction of goods into circulation, indicated by the participant in the turnover 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 enters information about the introduction of goods into circulation into the monitoring information system after receiving payment for the service of providing the marking code.

Payment for this service, stipulated by the Decree of the Government of the Russian Federation No. 577 of May 8, 2019 "On Approval of the amount of payment for the provision of services for providing marking codes Necessary for Forming Identification tools and Ensuring monitoring of the movement of Goods Subject to mandatory marking by identification tools, as well as on the Procedure for its collection", is made:

if the goods are marked by a participant in the turnover of goods independently - within 30 calendar days, starting from October 1, 2023, but not later than the date of entry into circulation of marked goods, the identification means of which are converted from the corresponding marking codes received up to September 30, 2023 (inclusive);

in case of marking of goods by the service provider-subject to payment of the specified marking codes within 365 calendar days, starting from October 1, 2023, but not later than the date of entry into circulation of marked goods, the identification means of which are converted from the corresponding marking codes.

69. Marking codes are cancelled in the following cases:

a) within the time limits established by paragraphs 67 or 68 of these Rules, the participant in the turnover of goods has not paid for services related to the provision of these marking codes;

b) within the time limits established by items 64 and (or) 66 of these Rules, a participant in the turnover of goods has not sent a report on the application of identification tools converted from these marking codes to the information monitoring system.

70. The operator of the monitoring information system refuses to enter information about the application of identification tools into the monitoring information system for the following reasons:

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

b) submission of a report on the application of identification tools by a participant in the turnover of goods after the expiration of the period established by paragraphs 64 and (or) 66 of these Rules;

c) the lack of information in the monitoring information system about the issue registration device used by the participant in the turnover of goods to send a report on the application of identification tools;

d) the operator of the monitoring information system does not have confirmation of payment for marking codes converted into identification tools, the report on the application of which must be transmitted to the monitoring information system in accordance with paragraphs 64 and (or) 66 of these Rules.

 

VII. Procedure for applying identification tools

 

71. Labeling of goods is carried out by the manufacturer or importer, including using 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, in the places of production or storage of goods-before the goods are put into circulation;

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

from the territory of states that are not members of the Eurasian Economic Union, as well as in the case of importation to the rest of the territory of the Russian Federation of goods produced in the territories of special (free) economic zones or territories equated to them from foreign raw materials and (or) components placed under the customs procedure of the 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-until they are placed under the customs procedures of release for domestic consumption or re-import;

from the territory of the member states of the Eurasian Economic Union in the framework of cross-border trade-before moving across the state border of the Russian Federation.

72. Participants in the turnover of goods who have made a decision on the sale of goods purchased for purposes not related to their subsequent sale (sale), or on the sale (sale) of goods purchased from the subject of a transaction, information about which is a state secret, or acquired as a result of trading in the framework of enforcement proceedings and bankruptcy procedures, owners of property confiscated in administrative and criminal proceedings, as well as based on the results of the sale of property converted into the property of the Russian Federation in accordance with the legislation of the Russian Federation, must ensure that unmarked goods are marked before they are sold (sold) to third parties, including before they are displayed at the place of sale (sale), their samples are shown.

73. Participants in the turnover of goods must ensure relabeling of goods supplied (sold) within the framework of purchase and sale transactions, as well as commission agreements, including those offered for sale (sale) after their return by the buyer, in case of loss or damage to the identification tool that excludes the possibility of its reading (recognition).

74. In the case of forming a set, the identification tool is applied to the set or label located on such a set, as well as to the consumer packaging of goods included in this set, or the label located on such consumer packaging.

75. Identification means are applied to consumer packaging, or group packaging, or a set, or a label located on such consumer or group packaging, or a set by a method that does not allow separation of the identification means without damage to the identification means.

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

76. The location of the identification tool applied to consumer packaging, or group packaging, or a set, should ensure unhindered reading by technical means designed to read Data Matrix and EAN-128 format codes.

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

 

VIII. Procedure and terms of submission by participants

product turnover in the information monitoring system

information about putting into circulation, on turnover and withdrawal from circulation

products to include in the information system

monitoring system

 

77. Producers (including in the framework of contract production) before the offer of goods for wholesale or retail sale( sale), including before their display at the place of sale (sale), demonstration of their samples (except for the presentation of information about goods when they are sold remotely), or third-party producers of goods before the transfer the manufacturer is notified of the introduction of goods into circulation and submits the following information to the monitoring information system:

manufacturer's taxpayer identification number;

10-digit code of the product range.

identification code, or group package identification code, or set identification code, or transport package identification code;

type of production order (own production, contract production).

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

registration number and date of issue (registration) of the permit 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.

Submission of information on the transfer of goods released under contract production from a third-party manufacturer of goods to the manufacturer is carried out in accordance with paragraph 94 of these Rules.

78. Importers after the release by the customs authorities of goods imported (imported) and placed under the customs procedures of release for domestic consumption or re-import, before the offer of these goods for sale( sale), including before their display at the place of sale (sale), demonstration of their samples, or before taking into account the goods imported to the Russian Federation, for purposes not related to their subsequent sale (sale), form a notification of the introduction of goods into circulation and submit the following information to the monitoring information system:

a) taxpayer identification number of the importer;

b) identification code, or group package identification code, or set identification code, or transport package identification code, or aggregated customs code;

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

(ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

d) registration number of the customs document;

(ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

e) registration number and date of issue (registration) of the permit 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 purpose of customs declaration of goods and transmission to the information monitoring system of notification of the introduction of goods into circulation, taking into account the requirements provided for in paragraph 78 of these Rules, identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages, and (or) the aggregated customs code is subject to indication in customs documents in accordance with the Procedure for Filling out a declaration for goods, approved by the Decision of the Customs Union Commission No. 257 of May 20, 2010, or the Procedure for filling out an application for the release of goods before filing a declaration for goods, approved by the Decision of the Board of the Eurasian Economic Commission No. 171 of December 13, 2017.

At the same time, it is not allowed to indicate in customs documents identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages, and (or) aggregated customs code that are already contained in another customs document or in the same customs document, with the exception of cases of making a decision on refusal to issue, revocation, cancellation of a customs document, as well as indications in the declaration for goods filed in respect of goods that were issued on the basis of an application for the release of goods prior to the filing of the declaration for goods.

At customs declaration of goods in accordance with the customs procedures of release for domestic consumption or re-import at the completion of customs procedures of a free customs zone and a free warehouse for the purpose of exporting goods produced and put into circulation from the territories of special (free) economic zones, territories equated to them, and territories of free warehouses to the rest of the territory of the product declarations identification codes, and / or group package identification codes, and / or set identification codes, or transport package identification codes, or aggregated Customs code are not specified.

(item 79 in the editorial office). Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

80. The aggregated customs code is formed by the operator of the monitoring information system according to the application sent by the importer to the monitoring information system and containing the following information:

a) taxpayer identification number of the importer;

b) a list of identification codes, and (or) identification codes for group packages, and (or) identification codes for sets to be included in the aggregated customs code.

81. Participants in the turnover of goods that import goods into the Russian Federation from the customs territory of the member states of the Eurasian Economic Union within the framework of cross - border trade, before displaying their samples at the place of sale (sale), demonstrating their samples or submitting information about them at the place of sale (sale) of goods, form a notification on the introduction of goods into circulation and submit add the following information to the information system:

a) taxpayer identification number of a participant in the turnover of goods that imports goods within the framework of cross-border trade;

b) 10-digit code of the product nomenclature;

c) identification code, or group package identification code, or set identification code, or transport package identification code;

d) the name of the member state of the Eurasian Economic Union, from the territory of which goods are imported (in accordance with the All-Russian Classifier of countries of the world);

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

f) name of the supplier organization;

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

h) details of a shipping 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 permit document in the presence of 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 transmits to the Unified Automated Information System of Customs Authorities, at the request of the Unified Automated Information System of Customs Authorities, the following information about marked goods:

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

b) taxpayer identification number, name of the taxpayer of the owner of identification codes, or identification codes for group packages, or identification codes for sets, or identification codes for transport packages, or an aggregated customs code;

c) identification code, or group package identification code, or set identification code, or transport package identification code, or aggregated customs code;

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

e) the number of units of goods declared under the group package identification code, or under the set identification code, or under the transport package identification code, or under the aggregated customs code;

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

g) date of receipt of the identification code, group package identification code, or set identification code, or transport package identification code, or aggregated customs code to the warehouse;

h) 10-digit code of the product nomenclature;

i) code of the reason for registering a participant in the turnover of goods (if any);

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

k) date of issue (registration) of the permit document in the presence of requirements for confirmation of conformity and (or) state registration of the goods;

m) date of registration certificate for the medical device;

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

o) trademark (if any).

83. The Unified automated Information System of Customs authorities transmits to the monitoring information system, at the request of the monitoring information system, the following information on the results of customs control of marked goods:

a) the type of customs document;

(item " a " in the ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

a(1)) code of the customs body that made the decision on the customs document;

(sub clause "a(1)" was introduced by Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

b) registration number and date of issue (registration) of the permit 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;

(item " d " in the ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

e) date of registration of the customs document;

(item " d " in the ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

f) code of the customs procedure;

g) code of the declaration particularity;

h) name of the sending organization;

i) the sender's country code;

j) name of the sender's country;

k) name of the recipient organization;

m) taxpayer identification number of the recipient;

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

o) taxpayer identification number of the goods declarant;

p) 10-digit code of the product nomenclature;

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

c) the customs value of the goods;

t) the price of goods (invoice value);

(ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

u) country of origin code in accordance with the All-Russian classifier of countries of the world;

f) the number of goods in an additional unit of measurement;

x) name of the additional unit of measurement;

c) code of the additional unit of measurement;

h) name of the goods;

(item "h" in the ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

w) the serial number of the product (s);

(item "w" in the ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

g) identification code, or group package identification code, or set identification code, or transport package identification code, or aggregated customs code;

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

e) gross weight, net weight;

j) code of the decision on the product in accordance with the classifier of decisions taken by the customs body;

i) date and time of the decision made on the product in accordance with the decision classifier.

84. When making changes (additions) to the information declared in the declaration for goods, after the release of goods, the Unified Automated Information System of Customs Authorities transmits, upon request, to the monitoring information system, adjusted data on the goods, as well as information on the declaration for goods filed in respect of goods issued on the basis of the application for release of goods before submitting the goods declaration.

(item 84 in the ed. Decree of the Government of the Russian Federation No. 1630 of 26.11.2024)

85. Information about the decision of the customs body in respect of marked goods obtained from the Unified Automated Information System of Customs Authorities is reflected in the monitoring information system.

86. Participants in the turnover of goods who have made a decision on the sale of goods purchased as a result of auctions held in the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in administrative or criminal proceedings, as well as on the results of the sale of property converted into the property of the Russian Federation in accordance with the legislation of the Russian Federation, form a notification on the entry of goods the following information is put into circulation and entered into the monitoring information system before these goods are offered for sale (sale), including before they are displayed at the place of sale (sale), and their samples are shown:

a) taxpayer identification number of the participant in the turnover of goods engaged in the specified turnover;

b) identification code, or group package identification code, or set identification code;

c) details of the primary accounting document confirming the acceptance of goods purchased as a result of auctions held in the framework of enforcement proceedings and bankruptcy procedures, auctions of property confiscated in administrative or criminal proceedings, as well as the results of the sale of property converted into the property of the Russian Federation in accordance with the legislation of the Russian Federation.

87. Participants in the turnover of goods have the right to post information about such goods, including a description of the goods, their image and cost, on the Internet using the remote method of selling goods, in catalogues, brochures, booklets, photographs, and means of communication (television, mail, radio, and others)until the goods are put into circulation or in other ways that exclude the possibility of direct acquaintance of the consumer with the goods or their samples for the sale (sale) of goods remotely, as well as to conclude contracts for the retail sale of goods remotely with consumers with the acceptance of advance payments or prepayment for the specified goods. Delivery of goods to consumers on the basis of a remote retail purchase and sale agreement concluded before the goods are put into circulation is allowed only after the goods are put into circulation.

88. Participants in the turnover of goods, if necessary, perform the operation of forming a set and submit to the monitoring information system before offering this set for sale (sale), including before it is displayed at the place of sale (sale), demonstrating its samples (with the exception of providing information about it when selling goods remotely), the following information:

a) taxpayer identification number of the goods turnover participant;

b) set identification code;

c) a list of identification codes included in the set of products.

89. When aggregating consumer packages into a group package, before transferring the group package to the next participant in the turnover of goods, the participant in the turnover of goods who performed the aggregation submits the following information to the monitoring information system:

group package identification code.

list of identification codes for aggregated consumer packages;

date of aggregation.

Information about the aggregation of goods in consumer packages into group packaging can be transmitted simultaneously with information about the aggregation of group packages into transport packaging before the transport package is transferred to the next participant in the turnover of goods.

90. Participants in the turnover of goods that perform the operation of aggregating goods into transport packages submit the following information to the monitoring information system:

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

identification number of the taxpayer participating in the turnover of goods that aggregated the goods into transport packaging of the first level;

identification code of the transport package to be created, as well as a list of identification codes, and (or) identification codes for group packages, and (or) identification codes for sets to be included in the identification code of the transport package to be created;

b) the result of performing a subsequent level aggregation operation by providing the following information:

identification number of the taxpayer participating in the turnover of goods that aggregated the goods into transport packaging of the next level;

identification code of the higher-level transport package to be created, as well as a list of identification codes for transport packages to be included in the identification code of the higher-level transport package to be created.

91. Participants in the turnover of goods that carry out the operation of disbanding transport packaging, submit the following information to the monitoring information system:

identification number of the taxpayer participating in the turnover of goods that carried out the dismantling of transport packaging;

identification codes for transport packages to be disbanded.

If participants in the turnover of goods submit to the monitoring information system information about the turnover or withdrawal from circulation of a part of goods that are, according to the monitoring information system, in transport packaging, the information monitoring system automatically registers the disbandment of all transport packages of a higher level of nesting that contained goods withdrawn from the specified packaging.

92. Participants in the turnover of goods, if necessary, carry out the operation of disbanding a group package or set and submit the following information to the monitoring information system:

a) taxpayer identification number of the participant in the turnover of goods that performed the operation of disbanding a group package or set;

b) a list of identification codes for group packages to be disbanded or identification codes for sets to be disbanded.

93. Participants in the turnover of goods that perform operations for the withdrawal or transfer of goods within the first-level transport package or first-level transport package within the next-level transport package, submit the following information to the monitoring information system:

identification number of the taxpayer participating in the turnover of goods that carried out operations for withdrawal or transfer;

type of transformation operation (shifting, removing).

list of identification codes, and (or) identification codes for group packages, and (or) identification codes for sets, and (or) identification codes for transport packages to be transformed.

The transport package identification code of the first and subsequent levels is disbanded only if, as a result of the package transformation operation, there are no other transport packages of the first level, or goods in consumer packages, or goods in group packages, or sets in transport packages of the first level.

94. When transferring (accepting) goods within the framework of transactions involving the transfer of ownership rights to the specified goods, as well as within the framework of commission agreements, and (or) agency agreements, and (or) contract agreements, and (or) assignment agreements, the participant in the turnover of goods that performs the shipment (acceptance) of goods forms a notification on the transfer (acceptance) of goods (in the format of a universal transfer document indicating the type of transaction in which the shipment is carried out), signs it with an enhanced electronic signature and sends it to the other party to the transaction in accordance with paragraph 23 of these Rules, and no later than 3 working days from the date of acceptance of goods, such notification is sent to the information monitoring system an electronic document management operator.

The specified notification must contain the following mandatory information:

taxpayer identification number of the buyer;

unit of measurement (code and corresponding symbol (national) in accordance with the All-Russian Classification of Units of Measurement) (if any);

the number of delivered (shipped) goods;

the price of goods per unit of measurement excluding value-added tax, and in the case of applying state regulated prices (tariffs) that include value-added tax, taking into account the amount of tax;

the value of the total quantity of goods delivered (shipped) without value-added tax (in cases stipulated by the Tax Code of the Russian Federation, the tax base is indicated);

tax rate.

the cost of the total quantity of goods delivered (shipped), including the amount of value-added tax;

the amount of value-added tax charged to the buyer of goods.

identification code, or group package identification code, or set identification code, or transport package identification code.

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

96. Participants in the turnover of goods that sell marked goods using cash registers send information about the turnover of goods to the monitoring information system, if the operation is carried out between participants in the turnover of goods registered in the monitoring information system, or about the withdrawal of goods from circulation by means of cash registers, and when performing operations, adjustments are made to the information about the price of goods per unit, taking into account discounts, surcharges, fees and taxes, the cost of goods, taking into account discounts, surcharges, fees and taxes, the rate of value-added tax included in the price of goods, about the withdrawal of marked goods from circulation by means of cash registers, is sent to the monitoring information system information about the adjustment of withdrawal from circulation turnover of goods by means of cash registers.

97. A participant in the turnover of goods selling goods with the use of cash registers identifies and recognizes the identification means applied to the goods by software and / or technical means associated with the cash registers installed in their possession and registered.

98. If there is an agreement with a participant in the turnover of goods who makes payments for goods or accepts returned goods with an undamaged means of identification in accordance with the Federal Law "On the Use of cash Registers when making payments in the Russian Federation", the fiscal data operator, on behalf of such a participant in the turnover of goods, performs daily transmission in real time of the information received from it to the operator of the monitoring information system for each sold unit of labeled goods in accordance with the protocol of information exchange between the fiscal data operator and the monitoring information system, including the following mandatory information:

a) taxpayer identification number of the user of cash register equipment (except for the cases established by the Federal Law "On the use of cash register equipment in making payments in the Russian Federation");

b) the code of the document form;

c) the serial number of the document;

d) date and time of document formation;

e) calculation attribute - receipt (receipt of funds from the buyer), refund of receipt (refund of funds received from the buyer), expense (disbursement of funds to the buyer), refund of expense (receipt of funds issued to the buyer from the buyer);

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

g) data on each unit of the product (product status (if available), price per unit of the calculation item including discounts and surcharges, fees and taxes, number of units of the product, cost of the calculation item including discounts and surcharges, fees and taxes, indicating the rate of value-added tax included in the price of the product);

h) registration number of cash register equipment;

i) the factory number of the fiscal storage device;

j) the address and place of settlement (except for the cases established by the Federal Law "On the Use of Cash Registers for Settlements in the Russian Federation");

k) the tax system used by the user when paying for marked goods;

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

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

99. Information on making payments using cash registers between participants in the turnover of goods is equal to the notification of the transfer (acceptance) of goods provided for in paragraph 94 of these Rules, and is the basis for the operator of the information monitoring system to reflect the fact of acceptance and transfer of goods in the information monitoring system.

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

101. Notification of registration in the monitoring information system of information on the turnover of marked goods, if the transaction is carried out between participants in the turnover of goods registered in the monitoring information system, or about the withdrawal of goods from circulation, or about refusal to register such information, is sent to the fiscal data operator and (or) the participant in the turnover of goods who with the use of cash register equipment, and (or) turnover participants who received and transferred goods using cash register equipment.

102. In case of using cash register equipment in a mode that does not provide for mandatory transfer of fiscal documents to tax authorities and the information monitoring system in electronic form through the fiscal data operator, as well as if a participant in the turnover of goods falls under the provisions of paragraphs 2 and 3 of Article 2 of the Federal Law "On the Use of Cash Register when performing settlements in the Russian Federation", participants in the turnover of goods 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 turnover of labeled goods if the transaction is carried out between participants in the turnover of goods registered in the monitoring information system, containing 98 of these Rules, through the personal account of a participant in the turnover of goods or through electronic information services using standard data transfer protocols and electronic interaction interfaces of the monitoring information system.

103. In case of return of marked goods by the consumer in accordance with the legislation of the Russian Federation on consumer rights protection, the participant in the turnover of goods submits information to the information monitoring system before offering such goods for sale (sale), including before they are displayed at the place of sale (sale), demonstrating their samples, in one of the following ways:

with the use of cash register equipment through the fiscal data operator in accordance with the procedures provided for in paragraphs 10196-101 of these Rules, independently or with the involvement of other legal entities or individual entrepreneurs authorized by a participant in the turnover of goods and acting on its behalf in accordance with the legislation of the Russian Federation;

independently enters the following information into the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

identification code, or group package identification code, or set identification code that is returned to circulation (if the product is returned with an undamaged identification device);

a new identification code, or a new identification code for a group package, or a new identification code for a set (if the product is returned with a damaged identification tool or without an identification tool);

details of documents confirming the return of marked goods.

When returning goods with damaged identification means or without identification means (there is no possibility to identify the goods) a participant in the turnover of goods before submitting to the information monitoring system the information provided for in paragraphs four to seven of this paragraph, performs relabeling of such goods in accordance with paragraphs 73 and 118 of these Rules.

104. When goods are withdrawn from circulation on grounds that are not retail sales, except for the cases provided for in paragraphs 106, 108, 109, 111 and 114 of these Rules, the participant in the turnover of goods who is withdrawing them from circulation, within 3 working days, submits to the monitoring information system the following information about the withdrawal of goods from circulation: turnover rate:

a) taxpayer identification number of the participant in the turnover of goods who is withdrawing goods from circulation;

b) the reason for the withdrawal of goods from circulation (destruction, expiration date, loss, use for medical use, etc.);

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

d) identification code, and (or) group package identification code, and (or) set identification code, withdrawn from circulation.

105. In case of return of goods previously withdrawn from circulation due to the use of goods for medical use, such a participant in the turnover of goods independently submits the following information to the monitoring information system:

a) taxpayer identification number of the participant in the turnover of goods that returns goods to circulation;

b) the reason for the return of goods to circulation (return of goods withdrawn from circulation for medical use);

c) identification code, or group package identification code, or set identification code returned to circulation.

106. When goods are withdrawn from circulation by selling them according to samples or remotely, including using a vending machine or postamat, the participant in the turnover of goods transmits to the monitoring information system one of the following methods:

with the use of cash register equipment through the operator of fiscal data, information in accordance with paragraphs 96 - 101 of these Rules independently or with the involvement of other legal entities or individual entrepreneurs authorized by a participant in the turnover of goods and acting on its behalf in accordance with the legislation of the Russian Federation;

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

identification number of the taxpayer participating in the turnover of goods that is withdrawing goods from circulation;

the reason for the withdrawal of goods from circulation (sale of goods according to samples, remote method of selling goods, sale of goods using a vending machine or postamat);

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

identification code, and (or) group package identification code, and (or) set identification code, withdrawn from circulation;

the cost of the goods being withdrawn from circulation (according to the data of the goods turnover participant's accounting).

107. In case of return of goods previously withdrawn from circulation by selling samples or remotely, including using a vending machine or postamat, to the storage warehouse of a participant in the turnover of goods, such a participant in the turnover of goods before offering these goods for sale( sale), including before they are displayed at the place of sale (sale), demonstration of their samples (with the exception of providing information about them when selling goods remotely), submits information to the monitoring information system in one of the following ways:

with the use of cash register equipment through the fiscal data operator, in accordance with the procedures provided for in paragraphs 10196-101 of these Rules, independently or with the involvement of other legal entities or individual entrepreneurs authorized by a participant in the turnover of goods and acting on its behalf in accordance with the legislation of the Russian Federation;

independently enters the following information into the monitoring information system:

identification number of the taxpayer participating in the turnover of goods that returns goods to circulation;

the reason for the return of goods to circulation (return of goods sold remotely, return of goods sold using a vending machine or postamat);

identification code, or group package identification code, or set identification code that is returned to circulation (if the product is returned with an undamaged identification device);

a new identification code, or a new identification code for a group package, or a new identification code for a set (if the product is returned with a damaged identification tool or without an identification tool).

When returning goods with damaged identification means or without identification means (there is no possibility to identify the goods) a participant in the turnover of goods before submitting to the information monitoring system the information provided for in paragraphs four to seven of this paragraph, performs relabeling of such goods in accordance with paragraphs 73 and 118 of these Rules.

108. When goods are withdrawn from circulation due to the placement of marked goods under the customs procedure for export, the participant in the turnover of goods who withdraws such goods from circulation submits to the monitoring information system a notification on the withdrawal of goods from circulation containing the following information:

a) the taxpayer identification number of the exporter;

b) identification code, or group package identification code, or set identification code, or transport package identification code, or aggregated customs code withdrawn from circulation;

c) date of registration of the goods declaration;

d) registration number of the goods declaration.

109. When goods are withdrawn from circulation due to their export to the member states of the Eurasian Economic Union within the framework of cross-border trade in the customs territory of the Eurasian Economic Union, the participant in the turnover of goods withdrawing such goods from circulation shall submit to the monitoring information system a notification on the withdrawal of goods from circulation containing the following information:

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

b) identification code, and (or) group package identification code, and (or) set identification code, and (or) transport package identification code withdrawn from circulation.

110. When returning goods withdrawn from circulation on the basis of items 108 or 109 of these Rules, the participant in the turnover of goods within 3 working days from the date of return of goods submits the relevant information to the monitoring information system.

When goods are returned with an undamaged means of identification, the goods are not re-marked, and the participant in the turnover of goods submits the following information to the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

identification code, and / or group package identification code, and / or set identification code.

When returning goods with damaged identification means or without identification means (there is no possibility to identify the goods) a participant in the turnover of goods performs their relabeling in accordance with paragraphs 73 and 118 of these Rules and submits the following information to the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

a new identification code, and / or a new group package identification code, and / or a new set identification code.

111. A participant in the turnover of goods selling (selling) goods under a transaction, information about which is a state secret, no later than 3 working days from the date of shipment (transfer or acceptance) of goods, submits the following information to the monitoring information system:

a) taxpayer identification number of the participant in the turnover of goods who is withdrawing goods from circulation;

b) identification code, and (or) group package identification code, and (or) set identification code, and (or) transport package identification code withdrawn from circulation;

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

d) the date of withdrawal of goods from circulation;

e) the identifier of the state contract under 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 a transaction is made (if any).

112. When returning goods withdrawn from circulation on the basis of paragraph 111 of these Rules, the participant in the turnover of goods within 3 working days from the date of return of goods submits the relevant information to the monitoring information system.

When goods are returned with an undamaged means of identification, the goods are not re-marked, and the participant in the turnover of goods submits the following information to the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

identification code, and / or group package identification code, and / or set identification code.

When returning goods with damaged identification means or without identification means (there is no possibility to identify the goods) a participant in the turnover of goods performs their relabeling in accordance with paragraphs 73 and 118 of these Rules and submits the following information to the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

a new identification code, and / or a new group package identification code, and / or a new set identification code.

113. Participants in the turnover of goods, in the event of making a decision on the sale (sale) of goods previously purchased under a transaction, information about which constitutes a state secret, under a transaction, information about which does not constitute a state secret, enter goods into circulation in the following order:

a) carry out marking of goods if goods were not marked earlier, in the order provided by these Rules;

b) prior to displaying goods at the place of sale (sale), demonstrating their samples (with the exception of providing information about it when selling goods remotely), form a notification about the introduction of goods into circulation and submit the following information to the monitoring information system:

identification number of the taxpayer participating in the turnover of goods;

identification code, and (or) group package identification code, and (or) set identification code;

identifier of the state contract under 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 goods are withdrawn from circulation in accordance with paragraph 111 of these Rules.

114. Participants in the turnover of goods who purchase goods for use for purposes not related to their subsequent sale(sale), with the exception of participants in the turnover of goods who purchase goods not for retail sale, as well as for use for carrying out activities in the field of health care and providing social and medical services, sign a notice confirming the transfer of the right property transfer from the seller to the buyer, in the format of a universal transfer document. If legal entities, branches of foreign legal entities and individual entrepreneurs who purchase goods for use for purposes not related to their subsequent sale (sale) 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 a participant in the turnover of goods engaged in their sale (sale). Participants in the turnover of goods that sell goods for use for purposes not related to their subsequent sale (sale), on the basis of a notification confirmed by the buyer confirming the transfer of ownership, no later than 3 business days from the date of shipment (transfer or acceptance) of goods, submit the following information to the monitoring information system:

a) taxpayer identification number of the participant in the turnover of goods who is withdrawing goods from circulation;

b) taxpayer identification number of a legal entity, a branch of a foreign legal entity, and an individual entrepreneur purchasing goods for use for purposes unrelated to their subsequent sale (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) group package identification code, and (or) set identification code, and (or) transport package identification code;

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

e) the date of withdrawal of goods from circulation;

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

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

115. Participants in the turnover of goods who return to the seller goods withdrawn from circulation by sale for use for purposes not related to their subsequent sale (sale), form a notification in the format of a universal correction document signed with an enhanced electronic signature by both participants in the turnover of goods, confirming the transfer of ownership from the buyer to the seller.

When goods are returned with an undamaged means of identification, the participant in the turnover of goods submits the following information to the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

identification code, and (or) group package identification code, and (or) set identification code;

details of documents confirming the return of goods.

When returning goods with damaged identification means or without identification means (there is no possibility to identify the goods) a participant in the turnover of goods performs their relabeling in accordance with paragraphs 73 and 118 of these Rules and submits the following information to the monitoring information system:

taxpayer identification number of the goods turnover participant accepting the goods;

a new identification code, and / or a new group package identification code, and / or a new set identification code;

details of documents confirming the return of goods.

116. Participants in the turnover of goods who have made a decision on the sale (sale) of goods previously purchased by them for purposes not related to their subsequent sale (sale), if necessary, re-label the goods and before offering these goods for sale (sale), including before they are displayed at the place of sale (sale) of goods sold remotely), submit to the monitoring information system a notification of their introduction into circulation, containing the following information:

a) taxpayer identification number of the goods turnover participant;

b) identification code, or identification code of a group package, or identification code of a set returned to circulation (if the identification means is not damaged or lost);

c) a new identification code, or a group package identification code, or a set identification code (if necessary, if the identification tool is lost or damaged).

117. Participants in the turnover of goods when entering into circulation of goods that have not been sold as of the date of introduction of mandatory labeling of goods, before offering these goods for sale (sale), submit to the monitoring information system a notification of entry into circulation containing the following information:

a) taxpayer identification number of the goods turnover participant;

b) identification code, or group package identification code, or set identification code;

c) registration number and date of issue (registration) of the permit 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. If it is necessary to carry out re-labeling in the event of damage or loss of the identification means applied to consumer packaging or labels with the identification means applied, a participant in the turnover of goods trading in goods before offering these goods for sale( sale), including before they are displayed at the place of sale (sale), demonstrating their samples (except for providing information about them when selling goods remotely), submits the following information to the monitoring information system:

a) an identification code, or a group package identification code, or a set identification code of a new identification tool;

b) identification code, or identification code of a group package, or identification code of a set of damaged or lost means of identification (if any).

 

IX. Procedure for making changes to the information contained in the Document.

in the monitoring information system

 

119. In case of changes in the information provided for in Sections II, III, VII and VIII of these Rules, the participant in the turnover of goods within 3 working days from the date of their change sends a notification to the monitoring information system about changes in this information.

120. If, prior to the transfer of information on the acceptance of goods by participants in the turnover of goods to the information monitoring system, it is established that the information specified in the transfer documents requires correction or correction, then:

a) a participant in the turnover of goods that has carried out the shipment (transfer) of goods, forms a notification (in the format of a universal correction document or a corrected universal transfer document indicating the identification code, or the identification code of a group package, or the identification code of a set, or the identification code of a transport package) on clarification of information about the transfer (acceptance) of goods, signed electronic signature of both participants in the turnover of goods, and sends it to the monitoring information system through the electronic document management operator;

b) the operator of the information monitoring system, after receiving a notification signed with enhanced electronic signatures by both participants in the turnover of goods on clarifying information about the transfer (acceptance) of goods, reflects in the register of means of identification of the information monitoring system the fact of the transfer of goods by one participant in the turnover of goods to another participant in the turnover of goods, taking into account the information contained in such notification.

121. If after acceptance of goods and transfer of information about it to the information monitoring system, participants in the turnover of goods have established that the information specified in the transfer documents requires correction or adjustment, then:

a) a participant in the turnover of goods that has carried out the shipment (transfer) of goods, forms a notification (in the format of a universal correction document or a corrected universal transfer document indicating the identification code, or the identification code of a group package, or the identification code of a set, or the identification code of a transport package) on clarification of information about the transfer (acceptance) of goods, signed electronic signature of both participants in the turnover of goods, and sends it to the monitoring information system through the electronic document management operator;

b) the operator of the information monitoring system, after receiving a notification signed with enhanced electronic signatures by both participants in the turnover of goods on clarifying information about the transfer (acceptance) of goods, reflects in the register of means of identification of the information monitoring system the fact of the transfer of goods by one participant in the turnover of goods to another participant in the turnover of goods, taking into account the information contained in such notification.

122. In order to cancel or correct information previously submitted to the monitoring information system about the withdrawal of goods from circulation in a manner other than retail sales, the goods turnover participant sends a notification to the monitoring information system about the cancellation of the previously sent notification with its details and, if necessary, submits a new notification containing the information specified in paragraph 104 of these rules. Rules.

123. It is not allowed to make changes to the monitoring information system concerning information previously submitted by a participant in the turnover of goods to the monitoring information system on the entry of goods into circulation, on the turnover of goods and on its withdrawal from circulation, during the period when the authorized federal executive body checks the activities of a participant in the turnover of goods who sent a notification of the change in information.

124. If there is a need to make changes to the information of the monitoring information system submitted in accordance with paragraph 33 of these Rules, the corrected acceptance document signed by both parties to the contract in the procurement information system in accordance with part 14 of Article 94 of the Federal Law on the Contract System is sent to the monitoring information system in accordance paragraph 33 of these Rules.