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Ministry of Justice

Russian Federation

On September 29, 2017 No. 48379

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of September 1, 2017 No. 585n

About approval of Administrative regulations of execution by the Federal Service on supervision in health sector of the state function on implementation of licensed control of pharmaceutical activities

According to orders of the Government of the Russian Federation of December 22, 2011 No. 1081 "About licensing of pharmaceutical activities" (The Russian Federation Code, 2012, No. 1, Art. 126; No. 37, Art. 5002; 2013, No. 16, Art. 1970; 2016, No. 40, the Art. 5738) and 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 execution by the Federal Service on supervision in health sector of the state function on implementation of licensed control of pharmaceutical activities.

Minister

V. I. Skvortsova

Approved by the Order of the Ministry of Health of the Russian Federation of September 1, 2017, No. 585n

Administrative regulations of execution by the Federal Service on supervision in health sector of the state function on implementation of licensed control of pharmaceutical activities

I. General provisions

Name of the state function

1. The state function regulated by these Administrative regulations (further - Administrative regulations), is implementation of licensed control of the pharmaceutical activities performed by legal entities including the organizations of wholesale trade by medicines for medical application, the pharmaceutical organizations, the medical organizations and their separate divisions (the centers (departments) of general medical (family) practice, out-patient clinic, medical assistant's and medical and obstetrical centers) located in rural settlements in which there are no pharmaceutical organizations, and the individual entrepreneurs having the license for pharmaceutical activities (further respectively - the state function, licensed control).

The name of the federal executive body performing the state function

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

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

3. 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. 4238, 4283) (further - the Federal Law "About Drug Circulation");

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, Art. 4160, 4187, 4287; No. 50, Art. 6975; 2017, No. 9, Art. 1276; No. 18, the Art. 2673) (further - the Federal Law of December 26, 2008 No. 294-FZ);

4) the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" (The Russian Federation Code, 2011, No. 19, Art. 2716; No. 30, Art. 4590; No. 43, Art. 5971; No. 48, Art. 6728; 2012, No. 26, Art. 3446; No. 31, Art. 4322; 2013, No. 9, Art. 874; No. 27, Art. 3477; 2014, No. 30, Art. 4256; No. 42, Art. 5615; 2015, No. 1, Art. 11, 72; No. 29, Art. 4342; Art. 4389; No. 44, Art. 6047; 2016, No. 1, Art. 50, 51; 2017, No. 31, the Art. 4765) (further - the Federal Law of May 4, 2011 No. 99-FZ);

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 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; 2017, №6, of Art. 958; No. 13, Art. 1942);

8) 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, Art. 2825; 2016, No. 51, the Art. 7406) (further respectively - the order of the Government of the Russian Federation of April 28, 2015 No. 415, the unified register of checks);

9) the order of the Government of the Russian Federation of December 22, 2011 No. 1081 "About licensing of pharmaceutical activities" (The Russian Federation Code, 2012, No. 1, Art. 126; No. 37, Art. 5002; 2013, No. 16, Art. 1970; 2016, No. 40, Art. 5738; 2017, No. 28, Art. 4165);

10) the order of the Government of the Russian Federation of November 21, 2011 No. 957 "About the organization of licensing of separate types of activity" (The Russian Federation Code, 2011, No. 48, Art. 6931; 2012, No. 17, Art. 1965; No. 36, Art. 4916; No. 37, Art. 5002; No. 39, Art. 5267; 2013, No. 24, Art. 3014; No. 44, Art. 5764; 2015, No. 1, Art. 279; No. 19, Art. 2820; No. 41, Art. 5670; 2016, No. 40, Art. 5738; No. 45, Art. 6264; No. 48, Art. 6783; 2017, No. 20, Art. 2920; No. 28, Art. 4165);

11) the order of the Government of the Russian Federation of July 10, 2014 No. 636 "About certification of the experts involved by the bodies authorized on implementation of the state control (supervision), bodies of municipal control to holding actions for control" (The Russian Federation Code, 2014, No. 29, the Art. 4142) (further - the order of the Government of the Russian Federation of July 10, 2014 No. 636);

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