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Ministry of Justice

Russian Federation

On March 16, 2017 No. 45975

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of December 26, 2016 No. 999n

About approval of Administrative regulations of the Federal Service on supervision in health sector on execution of the state function on implementation of federal state supervision in the sphere of drug circulation by means of the organization and conducting checks of compliance of the medicines for medical application which are in civil circulation, to the established requirements to their quality

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" (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, 5, of the Art. 506) I order to No.:

Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector on execution of the state function on implementation of federal state supervision in the sphere of drug circulation by means of the organization and conducting checks of compliance of the medicines for medical application which are in civil circulation, to the established requirements to their quality.

Minister

V. I. Skvortsova

Approved by the Order of the Ministry of Health of the Russian Federation of December 26, 2016, No. 999n

Administrative regulations of the Federal Service on supervision in health sector on execution of the state function on implementation of federal state supervision in the sphere of drug circulation by means of the organization and conducting checks of compliance of the medicines for medical application which are in civil circulation, to the established requirements to their quality

I. General provisions

Name of the state function

1. The state function regulated by these Administrative regulations (further - Administrative regulations), is implementation of federal state supervision in the sphere of drug circulation by means of the organization and conducting checks of compliance of the medicines for medical application which are in civil circulation, to the established requirements to their quality (further - the state supervision).

The name of the federal executive body performing the state function

2. Execution of the state function is performed by the Federal Service on supervision in health sector (further - Roszdravnadzor) and territorial authorities of Roszdravnadzor (further - territorial authorities) which list is given in appendix No. 1 to Administrative regulations.

3. The state supervision is exercised by the officials of Roszdravnadzor (territorial authorities) specified in Item 8 of the Regulations on federal state supervision in the sphere of the drug circulation approved by the order of the Government of the Russian Federation of October 15, 2012 No. 1043 (The Russian Federation Code, 2012, No. 43, Art. 5877; 2013, No. 24, Art. 2999; 2015, No. 25, Art. 3672; No. 37, Art. 5153; 2016, No. 38, Art. 5567):

1) head (deputy managers) of Roszdravnadzor (territorial authorities);

2) heads of structural divisions of Roszdravnadzor (territorial authorities), their deputies whose official regulations provide powers on implementation of the state supervision;

3) other government civil servants of Roszdravnadzor (territorial authorities) which official regulations provide powers on implementation of the state supervision.

The list of the regulatory legal acts regulating execution of the state function

4. Execution of the state function is performed according to:

2) the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 31, Art. 4161; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; No. 53, Art. 7587; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 11, Art. 1098; No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 10, Art. 1404; No. 27, Art. 3951; No. 29, Art. 4359, 4367, 4388; No. 51, Art. 7245; 2016, No. 1, Art. 9; No. 23, Art. 3287; No. 27, the Art. 4194, 4238, 4283) (further - the Federal Law of April 12, 2010 No. 61-FZ);

3) the Federal Law of December 26, 2008 No. 294-FZ "About protection of the rights of legal entities and individual entrepreneurs when implementing the state control (supervision) and municipal control" (The Russian Federation Code, 2008, No. 52, Art. 6249; 2009, No. 18, Art. 2140; No. 29, Art. 3601; No. 48, Art. 5711; No. 52, Art. 6441; 2010, No. 17, Art. 1988; No. 18, Art. 2142; No. 31, Art. 4160, 4193, 4196; No. 32, Art. 4298; 2011, No. 1, Art. 20; No. 17, Art. 2310; No. 23, Art. 3263; No. 27, Art. 3880; No. 30, Art. 4590; No. 48, Art. 6728; 2012, No. 19, Art. 2281; No. 26, Art. 3446; No. 31, Art. 4320, 4322; No. 47, Art. 6402; 2013, No. 9, Art. 874; No. 27, Art. 3477; No. 30, Art. 4041, 4243; No. 44, Art. 5633; No. 48, Art. 6165; No. 49, Art. 6338; No. 52, Art. 6961, 6979, 6981; 2014, No. 11, Art. 1092, 1098; No. 26, Art. 3366; No. 30, Art. 4220, 4235, 4243, 4256; No. 42, Art. 5615; No. 48, Art. 6659; 2015, No. 1, Art. 53, 64; 72; 85; No. 14, Art. 2022; No. 18, Art. 2614; No. 27, Art. 3950; No. 29, Art. 4339; 4362; 4372; 4389; No. 48, Art. 6707; 2016, No. 11, Art. 1495; No. 18, Art. 2503; No. 27, the Art. 4160, 4164, 4187, 4210, 4194, 4287) (further - the Federal Law of December 26, 2008 No. 294-FZ);

4) the Federal Law of February 9, 2009 No. 8-FZ "About ensuring access to information on activities of state bodies and local government bodies" (The Russian Federation Code, 2009, No. 7, Art. 776; 2011, No. 29, Art. 4291; 2013, No. 23, Art. 2870; No. 51, Art. 6686; No. 52, Art. 6961; 2014, No. 45, Art. 6141; No. 49, Art. 6928; 2015, No. 48, Art. 6723; 2016, No. 11, Art. 1493);

5) the Federal Law of May 2, 2006 No. 59-FZ "About procedure for consideration of addresses of citizens of the Russian Federation" (The Russian Federation Code, 2006, No. 19, Art. 2060; 2010, No. 27, Art. 3410; No. 31, Art. 4196; 2012, No. 31, Art. 4470; 2013, No. 19, Art. 2307; No. 27, Art. 3474; 2014, No. 48, Art. 6638; 2015, No. 45, the Art. 6206) (further - the Federal Law of May 2, 2006 No. 59-FZ);

6) the Federal Law of December 28, 2013 No. 412-FZ "About accreditation in national accreditation system" (The Russian Federation Code, 2013, No. 52, Art. 6977; 2014, No. 26, Art. 3366; 2016, No. 10, the Art. 1323) (further - the Federal Law of December 28, 2013 No. 412-FZ);

7) the order of the Government of the Russian Federation of September 3, 2010 No. 674 "About approval of Rules of destruction of substandard medicines, counterfeited medicines and counterfeit medicines" (The Russian Federation Code, 2010, No. 37, Art. 4689; 2012, No. 37, Art. 5002; 2016, No. 4, the Art. 535) (further - the order of the Government of the Russian Federation of September 3, 2010 No. 674);

8) the order of the Government of the Russian Federation of June 30, 2004 No. 323 "About approval of the Regulations on the Federal Service on supervision in health sector" (The Russian Federation Code, 2004, No. 28, Art. 2900; No. 33, Art. 3499; 2006, No. 52, Art. 5587; 2007, No. 12, Art. 1414; No. 35, Art. 4310; 2008, No. 46, Art. 5337; 2009, No. 2, Art. 244; 2009, No. 6, Art. 738; No. 33, Art. 4081; 2010, No. 26, Art. 3350; No. 35, Art. 4574; No. 45, Art. 5851; 2011, No. 2, Art. 339; No. 14, Art. 1935; 2012, No. 1, Art. 171; No. 20, Art. 2528; No. 26, Art. 3531; 2013, No. 20, Art. 2477; No. 45, Art. 5822; 2014, No. 37, Art. 4969; 2015, No. 2, Art. 491; No. 23, Art. 3333; 2016, No. 2, Art. 325; No. 28, Art. 4741);

9) the order of the Government of the Russian Federation of November 24, 2009 No. 953 "About ensuring access to information on activities of the Government of the Russian Federation and federal executive bodies" (The Russian Federation Code, 2009, No. 48, Art. 5832; 2012, No. 17, Art. 2002; 2013, No. 28, Art. 3838; No. 30, Art. 4107; 2014, No. 42, Art. 5735; 2016, No. 27, Art. 4494);

10) the order of the Government of the Russian Federation of June 30, 2010 No. 489 "About approval of rules of preparation by state control (supervision) bodies and bodies of municipal control of annual plans of conducting planned inspections of legal entities and individual entrepreneurs" (The Russian Federation Code, 2010, No. 28, Art. 3706; 2012, No. 2, Art. 301; No. 53, Art. 7958; 2015, No. 49, Art. 6964; 2016, No. 1, Art. 234; No. 30, Art. 4928; No. 35, Art. 5326; No. 38, the Art. 5542) (further - the order of the Government of the Russian Federation of June 30, 2010 No. 489);

11) 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 - the order of the Government of the Russian Federation of April 28, 2015 No. 415);

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