Document from CIS Legislation database © 2003-2023 SojuzPravoInform LLC

The document ceased to be valid since October 17, 2020 according to the Order of the Ministry of Health of the Russian Federation of July 29, 2020 No. 768n

It is registered

Ministry of Justice

Russian Federation

On March 17, 2017 No. 46014

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of December 26, 2016 No. 998n

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 observance by subjects of drug circulation of requirements to preclinical researches of medicines, to clinical trials of medicines, storage, transportation, leave, realization of medicines, use of medicines, destruction of medicines

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.:

1. 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 observance by subjects of drug circulation of requirements to preclinical researches of medicines, to clinical trials of medicines, storage, transportation, leave, realization of medicines, use of medicines, destruction of medicines.

2. Recognize invalid:

the order of the Ministry of Health and Social Development of the Russian Federation of September 29, 2011 No. 1090n "About approval of Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on control of destruction of medicines" (registration No. 22945) is registered by the Ministry of Justice of the Russian Federation on January 18, 2012;

the order of the Ministry of Health and Social Development of the Russian Federation on September 29, 2011 No. 1091n "About approval of Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development on execution of the state function on control of carrying out preclinical researches of medicines and clinical trials of medicines for medical application" (registration No. 23023) is registered by the Ministry of Justice of the Russian Federation on January 26, 2012.

Minister

V. I. Skvortsova

Approved by the Order of the Ministry of Health of the Russian Federation of December 26, 2016, No. 998n

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 observance by subjects of drug circulation of requirements to preclinical researches of medicines, to clinical trials of medicines, storage, transportation, leave, realization of medicines, use of medicines, destruction of medicines

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 observance by subjects of drug circulation of requirements to preclinical researches of medicines, to clinical trials of medicines, storage, transportation, leave, realization of medicines, use of medicines, destruction of medicines (further - the state supervision).

The name of the federal executive body performing the state function

2. The state supervision is exercised by the Federal Service on supervision in health sector (further - Roszdravnadzor) and territorial authorities of the Federal Service on supervision in health sector (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 November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" (The Russian Federation Code, 2011, No. 48, Art. 6724; 2012, No. 26, Art. 3442, Art. 3446; 2013, No. 27, Art. 3459, 3477; No. 30, Art. 4038; No. 39, Art. 4883; No. 48, Art. 6165; No. 52, Art. 6951; 2014, No. 23, Art. 2930; No. 30, Art. 4106, 4206, 4244, 4247, 4257; No. 43, Art. 5798; No. 49, Art. 6927, 6928; 2015, No. 1, Art. 72, 85; No. 10, Art. 1403, 1425; No. 14, Art. 2018; No. 27, Art. 3951; No. 29, Art. 4339, 4356, 4359, 4397; No. 51, Art. 7245; 2016, No. 1, Art. 9, 28; No. 18, Art. 2488; No. 27, Art. 4219);

3) 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 of April 12, 2010 No. 61-FZ);

4) 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; Art. No. 27 4160, 4187, 4287) (further - the Federal Law of December 26, 2008 No. 294-FZ);

5) 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);

6) 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);

7) the Federal Law of January 10, 2002 No. 7-FZ "About environmental protection" (The Russian Federation Code, 2002, No. 2, Art. 133; 2004, No. 35, Art. 3607; 2005, No. 1, Art. 25; No. 19, Art. 1752; 2006, No. 1, Art. 10; No. 52, Art. 5498; 2007, No. 7, Art. 834; No. 27, Art. 3213; 2008, No. 26, Art. 3012; No. 29, Art. 3418; No. 30, Art. 3616; 2009, No. 1, Art. 17; No. 11, Art. 1261; No. 52, Art. 6450; 2011, No. 1, Art. 54; No. 29, Art. 4281; No. 30, Art. 4590, 4591, 4596; No. 48, Art. 6732; 2012, No. 26, Art. 3446; 2013, No. 11, Art. 1164; No. 27, Art. 3477; No. 30, Art. 4059; No. 52, Art. 6971, 6974; 2014, No. 11, Art. 1092; No. 30, Art. 4220; No. 48, Art. 6642; 2015, No. 1, Art. 11; No. 27, Art. 3994; No. 29, Art. 4359; No. 48, Art. 6723; 2016, No. 1, Art. 24; No. 15, Art. 2066; No. 27, Art. 4187, 4291);

8) 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, Art. 1323);

9) 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, Art. 535);

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SoyuzPravoInform LLC.