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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 4, 2017 No. 1204

About approval of the Regulations on implementation of the state control of activities in the sphere of the address of biomedical cellular products

According to article 46 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

Approve the enclosed Regulations on implementation of the state control of activities in the sphere of the address of biomedical cellular products.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of October 4, 2017 No. 1204

Regulations on implementation of the state control of activities in the sphere of the address of biomedical cellular products

1. This Provision establishes procedure of the state control of activities in the sphere of the address of biomedical cellular products (further - the state control).

2. The state control is exercised for the purpose of the prevention, identification and suppression of violations of requirements of the legislation of the Russian Federation governing the relations in the sphere of the address of biomedical cellular products when implementing activities of subjects of the address of biomedical cellular products.

3. The state control is exercised by the Federal Service on supervision in health sector and its territorial authorities.

4. Provisions of the Federal Law "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control" and the Federal Law "About Biomedical Cellular Products" are applied to the relations connected with implementation of the state control, the organization and conducting checks of subjects of the address of biomedical cellular products.

5. The state control includes:

a) the organization and conducting checks of observance by subjects of the address of the biomedical cellular products established by the Federal Law "About Biomedical Cellular Products" and other regulatory legal acts of the Russian Federation of requirements to preclinical researches, clinical trials, production, realization, storage, transportation, import accepted according to it to the Russian Federation, to export from the Russian Federation, to application and destruction of biomedical cellular products;

b) the organization and conducting checks of compliance of the biomedical cellular products which are in circulation, to the quality indicators established by the regulating documentation on biomedical cellular product;

c) application according to the procedure, established by the legislation of the Russian Federation, measures for suppression of the revealed violations of requirements of the Federal Law "About Biomedical Cellular Products" and (or) on elimination of consequences of such violations, including decision making about suspension of the address of biomedical cellular products and issue of instructions about elimination of the revealed violations, and also accountability of persons who made such violations.

6. The state control is exercised by means of conducting scheduled and unscheduled, documentary and exit inspections according to Articles 9 - 13 and 14 Federal Laws "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control".

Preliminary coordination with bodies of prosecutor's office of terms of carrying out unscheduled inspection of subjects of the address of biomedical cellular products, and also the prior notice of legal entities, individual entrepreneurs of the beginning of conducting such check are not required. Bodies of prosecutor's office are informed on carrying out unscheduled inspection of subjects of the address of biomedical cellular products by the direction of the relevant documents within 3 working days from the date of the end of such check.

Concerning the separate organizations performing activities in the sphere of the address of biomedical cellular products, scheduled inspections are carried out with the frequency established by the list of types of activity in the health sector, education and the social sphere performed by legal entities and individual entrepreneurs concerning whom scheduled inspections are carried out with the established frequency, the approved order of the Government of the Russian Federation of November 23, 2009 No. 944 "About approval of the list of types of activity in the health sector, education and the social sphere performed by legal entities and individual entrepreneurs concerning whom scheduled inspections are carried out with the established frequency".

7. Terms and the sequence of carrying out ministerial procedures when implementing the state control are established by the administrative regulations developed and approved according to the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of execution of the state functions and administrative regulations of provision of the state services".

8. Officials, representatives to exercise the state control, are:

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