Order of the Government of the Russian Federation "About Procedure for Input in Civil Circulation of Medicines for Medical Application"

ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 31, 2025 No. 815

About procedure for input in civil circulation of medicines for medical application

According to article 52.1 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve enclosed:

Rules of representation according to parts 1, 1.1, 2, 2.1, 4, 4.1, 4.3 and 5 of article 52.1 of the Federal law "About Drug Circulation" of documents and data on the medicines for medical application introduced into civil circulation;

Rules of issue by federal state budgetary institutions of the Federal Law "About Drug Circulation" of the test report on compliance of series or batch of medicine specified regarding the 4th Article 52.1 for medical application to the quality indicators provided by the regulating documentation or the requirements established in case of registration according to the acts constituting the right of the Eurasian Economic Union;

Rules of carrying out the testing specified in parts 4, 4.1, 4.3 and 5 of article 52.1 of the Federal law "About Drug Circulation" including with use of means of remote interaction;

Rules of issue of permission to input in civil circulation of series or batch of immunobiological medicine, and also issue by the federal state budgetary institutions specified regarding the 4th article 52.1 of the Federal law "About Drug Circulation", the conclusion about compliance of series or batch of immunobiological medicine to the requirements established in case of its state registration or registration;

Rules of decision making about the termination of civil circulation specified in part 10 of article 52.1 of the Federal law "About Drug Circulation" of series or batch of medicine for medical application.

2. Determine that the amount of payment for issue:

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