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Ministry of Justice

Russian Federation

On July 26, 2019 No. 55419

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

of April 25, 2019 No. 3239

About approval of Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the sphere of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair)

According to orders of the Government of the Russian Federation of July 16, 2009 No. 584 "About notifying procedure for the beginning of implementation of separate types of business activity" (The Russian Federation Code, 2009, No. 30, Art. 3823; 2010, No. 16, Art. 1928; No. 44, Art. 5692; 2012, No. 1, Art. 171; No. 37, Art. 5002; 2013, No. 5, Art. 386; No. 8, Art. 826; No. 26, Art. 3338; No. 31, Art. 4214; No. 33, Art. 4391; 2014, No. 51, Art. 7466; 2016, No. 14, Art. 2001; 2017, No. 11, Art. 1577; No. 40, Art. 5848; No. 52, Art. 8121; 2018, No. 28, Art. 4215; No. 36, Art. 5647; No. 47, the Art. 7275) 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; No. 35, 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 acceptance and accounting of notifications on the beginning of implementation of activities in the sphere of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair).

Head

M. A. Murashko

Approved by the Order of the Federal Service of the Russian Federation on supervision in health sector of April 25, 2019, No. 3239

Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the sphere of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair)

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in health sector on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the sphere of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair) (further respectively - Administrative regulations, the state service) establish terms and the sequence of ministerial procedures (actions) of officials of the Federal Service for supervision in health sector (further - Roszdravnadzor) and its territorial authorities (further - territorial authority) by provision of the state service, and also order of interaction between structural divisions of Roszdravnadzor (territorial authorities), their officials, interactions of Roszdravnadzor (territorial authorities) with applicants by provision of the state service.

Circle of applicants

2. Applicants on receipt of the state service (further - applicants) are the legal entities and individual entrepreneurs assuming to perform the following types of activity in the sphere of the address of medical products: technical testing, toxicological researches, production, import to the territory of the Russian Federation, export from the territory of the Russian Federation, storage, transportation, realization, utilization, destruction of medical products.

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

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

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