ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 23, 2025 No. 1462

About approval of the Rules of voluntary provision in the state information system of monitoring of turnover of goods which are subject to obligatory marking by means of identification, information, its processing and application for the purpose of confirmation of country of source of the medicines for medical application which are subject to obligatory marking by means of identification

According to article 20.1 of the Federal law "About Bases of State Regulation of Trading Activity in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of voluntary provision in the state information system of monitoring of turnover of goods, means of identification, information, its processing and application which are subject to obligatory marking for the purpose of confirmation of country of source of the medicines for medical application which are subject to obligatory marking by means of identification.

2. The legal entities who are tax residents of the Russian Federation, performing the trading activity connected with acquisition and sale of the initial materials intended for production of medicines for medical application (further respectively - initial materials, medicines), at the same time being producers of medicines, performing use of initial materials in case of production of medicines, and also branches and representations of the foreign legal entities who are tax residents of state members of the Eurasian Economic Union and performing the trading activity in the Russian Federation connected with acquisition and sale of the initial materials which are at the same time producers of medicines and performing use of initial materials in case of production of medicines which intend to confirm implementation of all production stages (including synthesis of molecule of active ingredient of pharmaceutical substance) medicine in the territories of state members of the Eurasian Economic Union or initial materials of which are applied in case of production of medicines which all production stages are performed in the territories of state members of the Eurasian Economic Union (further - subjects of traceability), according to the Rules approved by this resolution:

a) from the date of entry into force of this resolution voluntarily give to the state information system of monitoring of turnover of goods, subject to obligatory marking by means of identification (further - information system of monitoring), the statement on their registration in information system of monitoring;

b) from the date of registration in information system of monitoring provide readiness of own software and hardware for information exchange with information system of monitoring and send to the operator of information system of monitoring the request for passing of testing of information exchange electronically;

c) from the date of registration in information system of monitoring and passing of the testing provided by the subitem "b" of this Item about day of receipt of the document containing data on the stages of engineering procedure of production of medicine performed in the territory of the Eurasian Economic Union (further - the document on production stages), voluntarily give to information system of monitoring of the data on the initial materials necessary for implementation of all production stages of medicine (including synthesis of molecule of active ingredient of pharmaceutical substance) in the territories of state members of the Eurasian Economic Union according to the stages of engineering procedure of production of medicine specified in industrial regulations or the regulating documents provided by rules of proper production practice of the Eurasian Economic Union (further - industrial regulations or the regulating documents), on the corresponding medicine for which receipt of the document on production stages is planned;

d) from the date of registration in information system of monitoring and passing of the testing provided by the subitem "b" of this Item voluntarily give to information system of monitoring of the data on acquisition and use of the initial materials specified in industrial regulations or the regulating documents on the corresponding medicine for which receipt of the document on production stages is planned or the document on production stages is received;

e) provide according to the Rules approved by this resolution, transfer of the data provided by the subitem "g" of this Item, automatically in real time, allowing to provide continuity of transfer of data in information system of monitoring and compliance of the provided information to the data on initial materials containing in information systems of subjects of traceability including data on the transactions with initial materials accompanying financial and economic activities of subjects of traceability.

3. The legal entities and physical persons registered as individual entrepreneurs, who are tax residents of the Russian Federation, performing production of initial materials and (or) the trading activity connected with acquisition and sale of the initial materials used in case of production of medicines by subjects of traceability (further - participants of turnover of initial materials), according to the Rules approved by this resolution:

a) voluntarily submit to information system of monitoring the registration application of participants of turnover of initial materials in information system of monitoring;

b) from the date of registration of participants of turnover of initial materials in information system of monitoring provide readiness of own software and hardware for information exchange with information system of monitoring and send to the operator of information system of monitoring the request for passing of testing of information exchange electronically;

c) from the date of registration of participants of turnover of initial materials in information system of monitoring and passing of the testing provided by the subitem "b" of this Item voluntarily give to information system of monitoring of the data on turnover of the initial materials used in case of production of medicines by subjects of traceability;

d) provide according to the Rules approved by this resolution, transfer of the data provided by the subitem "v" of this Item, automatically in real time, allowing to provide continuity of transfer of data in information system of monitoring and compliance of the provided information to the data on initial materials containing in information systems of participants of turnover of initial materials.

4. Registration in the information system used for the purpose of ensuring carrying out experiment according to the order of the Government of the Russian Federation of December 22, 2023 with No. 2261 "About carrying out in the territory of the Russian Federation experiment on traceability of medicines for the medical application and raw materials used for production of medicines for medical application" (further - experiment), legal entities and individual entrepreneurs who as of August 31, 2025 were participants of experiment is equated to registration in information system of monitoring according to the subitem "an" of Item 2 or the subitem "an" of Item 3 of this resolution.

If the information provided within the experiment by subjects of traceability or participants of turnover of initial materials for registration in the information system used for the purpose of ensuring carrying out experiment does not answer provisions of the Rules approved by this resolution regarding the procedure of registration in information system of monitoring, subjects of traceability and participants of turnover of initial materials provide in information system of monitoring missing and (or) urgent data according to Items 2 and 3 of this resolution.

5. Determine that the operator of information system of monitoring provides the organization of testing of information exchange of software and hardware of subjects of traceability and (or) participants of turnover of initial materials and information system of monitoring.

6. This resolution becomes effective from the date of its official publication.

Approved by the Order of the Government of the Russian Federation of September 23, 2025 No. 1462

Rules of voluntary provision in the state information system of monitoring of turnover of goods, means of identification, information, its processing and application which are subject to obligatory marking for the purpose of confirmation of country of source of the medicines for medical application which are subject to obligatory marking by means of identification

I. General provisions

1. These rules determine:

procedure for voluntary provision in the state information system of monitoring of turnover of goods, subject to obligatory marking by means of identification (further - information system of monitoring), information for the purpose of confirmation of country of source of medicines for medical application, its amount and structure;

procedure for processing and application of information which is voluntarily provided in information system of monitoring for the purpose of confirmation of country of source of medicines for medical application.

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