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Ministry of Justice

Russian Federation

On July 25, 2019 No. 55388

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN HEALTH SECTOR

of May 6, 2019 No. 3371

About approval of Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in state registration of medical products

According to the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2011, No. 15, Art. 2038; No. 27, Art. 3873; Art. 3880; No. 29, Art. 4291; No. 30, Art. 4587; No. 49, Art. 7061; 2012, No. 31, Art. 4322; 2013, No. 14, Art. 1651; No. 27, Art. 3477; Art. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6952; Art. 6961; Art. 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; No. 49, Art. 6928; 2015, No. 1, Art. 67; Art. 72; No. 10, Art. 1393; No. 29, Art. 4342; Art. 4376; 2016, No. 7, Art. 916; No. 27, Art. 4293; Art. 4294; 2017, No. 1, Art. 12; No. 31, Art. 4785; No. 50, Art. 7555; 2018, No. 1, Art. 63; No. 9, Art. 1283; No. 17, Art. 2427; No. 18, Art. 2557; No. 24, Art. 3413; No. 27, Art. 3954; No. 30, Art. 4539; No. 31, Art. 4858; the official Internet portal of legal information http://www.pravo.gov.ru, on April 1, 2019), orders of the Government of the Russian Federation of December 27, 2012 No. 1416 "About approval of Rules of state registration of medical products" (The Russian Federation Code, 2013, No. 1, Art. 14; No. 43, Art. 5556; 2014, No. 30, Art. 4310; 2017, No. 8, Art. 1233; 2018, No. 24, the Art. 3523) and of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; №35, of Art. 5092; 2012, No. 28, Art. 3908; No. 36, Art. 4903; No. 50, Art. 7070; No. 52, Art. 7507; 2014, No. 5, Art. 506; 2017, No. 44, Art. 6523; 2018, No. 6, Art. 880; No. 25, Art. 3696; No. 36, Art. 5623; 46, of the Art. 7050) I order to No.:

Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in state registration of medical products.

Head

M. A. Murashko

Approved by the Order of the Federal Service of the Russian Federation on supervision in health sector of May 6, 2019, No. 3371

Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in state registration of medical products

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in health sector (further - Roszdravnadzor) on provision of the state service in state registration of medical products (further respectively - Administrative regulations, the state service) establish terms and the sequence of ministerial procedures (actions) of Roszdravnadzor, in the course of provision of the state service, order of interaction between structural divisions of Roszdravnadzor, his officials, and also interactions of Roszdravnadzor with applicants, other public authorities and local government bodies by provision of the state service.

Circle of applicants

2. Applicants on provision of the state service (further - applicants) are:

1) developer of medical product;

2) producer (manufacturer) of medical product;

3) authorized representative of the producer (manufacturer) of medical product.

Requirements to procedure for informing on provision of the state service

3. Informing on procedure for provision of the state service is performed:

on the official site of Roszdravnadzor on the Internet (further - the official site of Roszdravnadzor, Internet network);

on the official site in the federal state information system "Single Portal of the State and Municipal Services" (further - the Single portal);

in the federal state information system "Federal Register of the State Services (Functions)" (further - the federal register);

at information stands in reception on work with addresses of citizens;

on phone numbers for reference.

4. Reference information concerning provision of the state service is placed:

on the official site of Roszdravnadzor;

on the Single portal;

in the federal register;

at information stands.

5. Reference information is provided by officials of Roszdravnadzor by phone, on personal acceptance of the applicant or in writing the mailing or the electronic message to the address specified by the applicant.

Reference information includes data on the location, the working schedule, telephone numbers for enquiries, number of phone informant, addresses of the official site, e-mail and (or) form of feedback with Roszdravnadzor.

6. On the official site of Roszdravnadzor and on the Single portal the following information is placed:

procedure for receipt of information by applicants concerning provision of the state service;

the list of the regulatory legal acts of the Russian Federation regulating provision of the state service;

text of Administrative regulations;

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