ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of January 19, 2018 No. 20n

About approval of Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of permission to performing clinical trial of medicine for medical application

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. 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. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6952, 6961, 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; 2015, No. 1, Art. 67, 72; 2015, No. 10, Art. 1393; No. 29, Art. 4342, 4376; 2016, No. 7, Art. 916; No. 27, Art. 4293, 4294; 2017, No. 1, the Art. 12), 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, No. 5, Art. 506; 2017, 44, of the Art. 6523) I order to No.:

1. Approve the enclosed Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of permission to performing clinical trial of medicine for medical application.

2. Recognize invalid:

the order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 No. 748n "About approval of approval procedure on performing clinical trial of medicine for medical application" (registration No. 18317) is registered by the Ministry of Justice of the Russian Federation on August 31, 2010;

the order of the Ministry of Health of the Russian Federation of March 13, 2015 No. 111n "About modification of the approval procedure on performing clinical trial of medicine for medical application approved by the order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 No. 748n" (registration No. 36922) is registered by the Ministry of Justice of the Russian Federation on April 20, 2015.

Approved by the Order of the Ministry of Health of the Russian Federation of January 19, 2018, No. 20n

Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of permission to performing clinical trial of medicine for medical application

I. General provisions

Subject of regulation of regulations

1. The administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of permission to performing clinical trial of medicine for medical application (further respectively - the Ministry, medicine) establish terms and the sequence of ministerial procedures (actions) of the Ministry performed at the request of the applicant in the limits set by regulatory legal acts of the Russian Federation of powers according to requirements of the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" <1> (further - the Federal Law No. 210-FZ), and also order of interaction between structural divisions of the Ministry, his officials, interactions of the Ministry with applicants, other public authorities by provision of the state service (further - Administrative regulations, the state service).

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<1> Russian Federation Code, 2010, No. 31, Art. 4179; 2011, No. 15, Art. 2038; No. 27, 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. 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. 1, Art. 67; No. 1, Art. 72; 2015; No. 10, Art. 1393; No. 29, Art. 4342, Art. 4376; 2016, No. 10, Art. 916; No. 27, Art. 4293; 4294; 2017, No. 1, Art. 12; No. 50, Art. 7555.

Circle of applicants

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

1) developer of medicine or person authorized by it;

2) educational institutions of higher education and (or) educational institutions of additional professional education;

3) research organizations.

Requirements to procedure for informing on provision of the state service

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

1) by means of placement of information, including on graphics of acceptance of applicants and phone numbers for reference (consultations), on the official site of the Ministry on the Internet of www.rosminzdrav.ru (further - the official site of the Ministry);

2) in the federal state information system "Single Portal of the State and Municipal Services (Functions)" www.gosuslugi.ru (further - the Single portal);

3) on phone numbers for reference;

4) in mass media.

4. Reference information (the Ministry location, the schedule of its work, telephone numbers for enquiries of structural division of the Ministry providing the state service) is posted on the official site of the Ministry, the Single portal, in the federal state information system "Federal Register of the State and Municipal Services (Functions)" (further - the Federal register).

4.1. On the Single portal the following information is placed:

1) the exhaustive list of the documents necessary for provision of the state service, the requirement to execution of the specified documents, and also the list of documents which the applicant has the right to provide on own initiative;

2) circle of applicants;

3) term of provision of the state service;

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