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Ministry of Justice

Russian Federation

On October 3, 2017 No. 48406

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of September 8, 2017 No. 621n

About modification of Administrative regulations of the Federal Service on supervision in the field of health care of execution of the state functions on control of the address of medical products, on implementation of licensed control of activities for production and maintenance of medical equipment, medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system in the territory of the innovative center "Skolkovo"), activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants

I order:

Approve the enclosed changes which are made to administrative regulations of the Federal Service on supervision in the field of health care of execution of the state functions on control of the address of medical products, on implementation of licensed control of activities for production and maintenance of medical equipment, medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system in the territory of the innovative center "Skolkovo"), activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants.

Vr.i.o. Minister

I. N. Kagramanyan

Approved by the Order of the Ministry of Health of the Russian Federation of September 8, 2017 No. 621n

Changes which are made to Administrative regulations of the Federal Service on supervision in the field of health care of execution of the state functions on control of the address of medical products, on implementation of licensed control of activities for production and maintenance of medical equipment, medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system in the territory of the innovative center "Skolkovo"), activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants

1. In the Administrative regulations of execution by the Federal Service on supervision in the field of health care on execution of the state function on control of the address of medical products approved by the order of the Ministry of Health of the Russian Federation of April 5, 2013 No. 196n (registration No. 29290) is registered by the Ministry of Justice of the Russian Federation on August 7, 2013, with the changes made by orders of the Ministry of Health of the Russian Federation of November 1, 2013 No. 813n (it is registered by the Ministry of Justice of the Russian Federation on December 18, 2013, registration No. 30634) and of July 18, 2016 No. 521n (registration No. 43151) is registered by the Ministry of Justice of the Russian Federation on August 8, 2016:

1) in Item 3:

a) add subitem 2 with words "(further - the Federal Law No. 294-FZ)";

b) declare subitem 9 invalid;

c) add with subitems 14.1 - 14.3 following of content:

"14. 1) the order of the Government of the Russian Federation of April 28, 2015 No. 415 "About Rules of forming and maintaining the unified register of checks" (The Russian Federation Code, 2015, No. 19, the Art. 2825) (further respectively - Rules, the unified register of checks);

14. 2) the order of the Government of the Russian Federation of April 18, 2016 No. 323 "About sending an inquiry and obtaining on a grant basis, including electronically, documents and (or) information state control (supervision) bodies, bodies of municipal control under the organization and conducting checks from other state bodies, local government bodies or subordinated to state bodies or local government bodies of the organizations at which disposal these documents and (or) information are, within interdepartmental information exchange" (The Russian Federation Code, 2016, No. 17, the Art. 2418) (further - Rules of sending an inquiry and receipt of documents and (or) information);

14. 3) the order of the Government of the Russian Federation of April 19, 2016 No. 724-r about approval of the list of documents and (or) information requested and received within interdepartmental information exchange by state control (supervision) bodies, bodies of municipal control (supervision) under the organization and conducting checks from other state bodies, local government bodies or the organizations at which disposal these documents and (or) information (The Russian Federation Code, 2016, No. 18, of Art. 2647 are; No. 42, Art. 5972);";

2) in Item 6:

a) add with subitem 7.1 of the following content:

"7. 1) to acquaint the head, other official or the authorized person of the subject of the address of medical products with the documents and (or) information received within interdepartmental information exchange;";

b) add subitem 13 with the words "in case of its availability at the licensee";

Item 15 to add 3) with paragraphs of the following content:

"In case of need when conducting check of small business entity (small enterprise, the microcompany) receipts of documents and (or) information within interdepartmental information exchange conducting check can be suspended by the head (deputy manager) of Roszdravnadzor for the term necessary for implementation of interdepartmental information exchange, but no more than for 10 (ten) working days. Repeated suspension of conducting check is not allowed.

For action of term of suspension of conducting check are suspended connected from the officials of Roszdravnadzor who are carrying out exit inspection in the territory specified by check in buildings, structures, constructions, rooms, on other objects of small business entity.";

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