FEDERAL LAW OF THE RUSSIAN FEDERATION

of August 4, 2026 No. 324-FZ

About introduction of amendments to the Federal law "About Drug Circulation" and separate legal acts of the Russian Federation

Accepted by the State Duma on July 23, 2026

Approved by the Federation Council on July 24, 2026

Article 1

Bring in the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; 2011, No. 50, Art. 7351; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 52, Art. 7540; 2018, No. 24, Art. 3407; No. 49, Art. 7521; 2019, No. 52, Art. 7780, 7793, 7796; 2021, No. 24, Art. 4188; No. 27, Art. 5145; 2022, No. 1, Art. 32; No. 13, Art. 1953; No. 43, Art. 7268; No. 50, Art. 8796; No. 52, Art. 9349; 2024, No. 6, Art. 764; No. 53, Art. 8504; 2025, No. 31, Art. 4658; No. 51, Art. 8002; 2026, No. 18, Art. 2294) following changes:

To add 1) with Article 8.3 of the following content:

"Article 8.3. Features of licensing of production of medicines for medical application

1. If by results of assessment of observance by the licensee of licensed requirements which is carried out according to article 19 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" gross violations of licensed requirements which are the critical discrepancies to requirements of rules of proper production practice of the Eurasian Economic Union determined by rules of conducting pharmaceutical inspections on compliance to requirements of rules of proper production practice of the Eurasian Economic Union and which entailed established by part 10 of article 19.2 of the specified Federal Law of effect are revealed action of the license for production of medicines for medical application and (or) the certificate of conformity of production of medicines for medical application to requirements of rules of proper production practice of the Eurasian Economic Union stops concerning all or separate works provided by such license and (or) the certificate for the term which is not exceeding hundred twenty days from the date of acceptance by the licensing body of the decision on suspension of action such licenses and (or) the certificate. The specified term can be prolonged for sixty days according to the application of the licensee which is submitted not earlier than sixty days from the date of acceptance by the licensing body of the decision on suspension of action such licenses and (or) the certificate. If the licensee performs the licensed type of activity in several places, can be suspended the license concerning the performed works on one or several places of implementation of the licensed type of activity.

2. If by results of assessment of observance by the licensee of licensed requirements which is carried out according to article 19 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" gross violations of licensed requirements which are the essential discrepancies to requirements of rules of proper production practice of the Eurasian Economic Union determined by rules of conducting pharmaceutical inspections on compliance to requirements of rules of proper production practice of the Eurasian Economic Union are revealed provisions, the stipulated in Article 20 Federal Laws of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" are applied.

3. Action of the license for the production of medicines for medical application and (or) the certificate of conformity of production of medicines for medical application to requirements of rules of proper production practice of the Eurasian Economic Union suspended according to part of 1 this Article is resumed according to the decision of the licensing body according to article 20 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity". In case of not elimination by the licensee during suspension of action of the license for production of medicines for medical application and (or) the certificate of conformity of production of medicines for medical application to requirements of rules of proper production practice of the Eurasian Economic Union of the revealed violations specified regarding 1 this Article, the licensing body terminates such the license and (or) the certificate after the term of suspension of their action.";

2) in part 7 of Article 9:

a) in Item 1 of the word "civil circulation" to replace with the word "address";

b) in Item 2 of the word "from civil circulation" shall be replaced with words "from the address and destruction";

3) part 6 of Article 11 to recognize invalid;

4) in Article 39:

a) in part 2:

state Item 11 in the following edition:

"11) the documents confirming quality of medicine for the medical application made for clinical trials including the document constituted by producer of medicine for medical application and containing indicators (characteristics) of quality of medicine (except for biological medicines);";

add with Item 13 of the following content:

"13) information on the data on safety and efficiency of medicine proving use of the researched medicine, including use of the declared methods of introduction and dosages, for the corresponding groups of patients at the corresponding duration of research obtained as a result of carrying out preclinical researches.";

b) in part 6 of the word "and 11.1" shall be replaced with words ", 11.1 and 13";

Part 3 of Article 47 to add 5) with the offer of the following content: "Import to the Russian Federation of tests (samples) of the medicines which are selected during conducting pharmaceutical inspections on compliance to requirements of rules of proper production practice of the Eurasian Economic Union, according to the procedure and on conditions which are provided by this part is allowed.";

Part 2 of Article 56 to add 6) with the offer of the following content: "In case of production of medicines for veterinary application use of the pharmaceutical substances made for realization included in the state register of medicines by the authorized federal executive body performing maintaining the state register of medicines for medical application is allowed.".

Article 2

Regarding 4.1 articles 1 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" (The Russian Federation Code, 2011, No. 19, Art. 2716; No. 48, Art. 6728; 2013, No. 27, Art. 3477; 2014, No. 30, Art. 4256; No. 42, Art. 5615; 2015, No. 1, Art. 11, 72; No. 27, Art. 3951; No. 29, Art. 4339, 4342; 2016, No. 1, Art. 50; 2017, No. 31, Art. 4765; 2018, No. 1, Art. 35; No. 45, Art. 6841; 2019, No. 16, Art. 1817; No. 30, Art. 4142; No. 31, Art. 4457; No. 52, Art. 7799; 2020, No. 31, Art. 5029; 2021, No. 18, Art. 3067; No. 24, Art. 4186, 4188; 2022, No. 29, Art. 5220, 5238; 2023, No. 25, Art. 4393; No. 29, Art. 5317; 32, the Art. 6160) the words "or terminations" shall be replaced with words No. ", renewals or the terminations".

Article 3

Part 12 of article 66 of the Federal Law of July 31, 2020 No. 248-FZ "About the state control (supervision) and municipal control in the Russian Federation" (The Russian Federation Code, 2020, No. 31, Art. 5007; 2021, No. 24, Art. 4188; 2024, No. 33, Art. 4985; 53, the Art. 8550) after words of "the specified data" to add No. with words ", and when implementing federal state licensed control of activities for production of medicines for medical application - within seventy two hours after receipt of the specified data".

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