FEDERAL LAW OF THE RUSSIAN FEDERATION

of July 2, 2021 No. 317-FZ

About introduction of amendments to the Federal law "About Drug Circulation"

Accepted by the State Duma on June 16, 2021

Approved by the Federation Council on June 23, 2021

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. 48, Art. 6165; 2014, No. 52, Art. 7540; 2018, No. 24, Art. 3407; No. 49, Art. 7521; 2019, No. 52, Art. 7780, 7793) following changes:

Article 47 to add 1) with part 10 of the following content:

"10. Input in civil circulation of the medicines for veterinary application imported (moved) into the Russian Federation is performed with observance of requirements, the stipulated in Clause 52.2 presents of the Federal Law.";

To add 2) with Article 52.2 of the following content:

"Article 52.2. Input in civil circulation of medicines for veterinary application

1. Before input in civil circulation of each series of the medicine made in the Russian Federation for veterinary application, except for immunobiological medicine for veterinary application, the producer of such medicine represents in notifying procedure to the federal executive body performing functions on control (supervision) in the field of drug circulation for veterinary application:

1) the document of the producer of medicines confirming compliance of quality of medicine for the veterinary application introduced into civil circulation, to the requirements established in case of its state registration;

2) confirmation of the authorized person of the producer of medicines of compliance of medicine for veterinary application to the requirements established in case of its state registration.

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