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:

the test report about compliance of series or batch of medicine 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 constitutes 1200 rubles;

the conclusions about compliance of series or batch of immunobiological medicine to the requirements established in case of its state registration or registration are constituted by 2000 rubles.

3. Realization of the powers provided by this resolution is performed by the corresponding federal executive bodies within the limiting Russian Federation established by the Government of number and the salary fund of their workers, and also budgetary appropriations provided in the federal budget on management and management in the established fields of activity.

4. This resolution is effective within 6 years.

Approved by the Order of the Government of the Russian Federation of May 31, 2025 No. 815

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

1. These rules establish procedure for submission to the Federal Service on supervision in the field of health care of documents and data on each series or each batch of the medicine made in the Russian Federation or imported into the Russian Federation for the medical application (further medicine) introduced into civil circulation in the Russian Federation, except for immunobiological medicine.

2. The Federal Service on supervision in the field of health care provides to producer of medicines or the organization performing import of medicines to the Russian Federation (further - the importer), the authorized access to the automated information system of the Federal Service on supervision in the field of health care (further - the automated information system) by means of provision of personal account in such information system for submission of the documents and data specified in Items 3 - 5 these rules.

3. The producer of medicines before input in civil circulation of each series or each batch of the medicine made in the Russian Federation represents to the Federal Service on supervision in the field of health care through personal account in the automated information system:

a) for each series or each batch of the medicine made in the Russian Federation for medical application (further - medicine):

the document of the producer of medicines confirming quality of medicine;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info