ORDER OF THE MINISTRY OF INDUSTRY AND TRADE OF THE RUSSIAN FEDERATION

of December 31, 2015 No. 4369

About approval of Administrative regulations on provision by the Ministry of Industry and Trade of the Russian Federation of the state service in issue of the document which confirms that production of medicine for medical application is performed according to requirements of rules of proper production practice, and is subject to representation upon the demand of authorized body of the country into which medicine is imported

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. 3873, 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. 3477, 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; 2015, No. 1, the Art. 67, the Art. 72, No. 10, the Art. 1393, No. 29, the Art. 4342, the Art. 4376), 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 on provision by the Ministry of Industry and Trade of the Russian Federation of the state service in issue of the document which confirms that production of medicine for medical application is performed according to requirements of rules of proper production practice and is subject to representation upon the demand of authorized body of the country into which medicine is imported.

2. To impose control of execution of this order on the deputy minister of Tsyba S.A.

Approved by the Order of the Ministry of Industry and Trade of the Russian Federation of December 31, 2015, No. 4369

The administrative regulations on representation by the Ministry of Industry and Trade of the Russian Federation of the state service in issue of the document which confirms that production of medicine for medical application is performed according to requirements of rules of proper production practice and are subject to representation upon the demand of authorized body of the country into which medicine is imported

I. General provisions

Subject of regulation of administrative regulations

1. The administrative regulations on provision by the Ministry of Industry and Trade of the Russian Federation of the state service in issue of the document which confirms that production of medicine for medical application is performed according to requirements of rules of proper production practice and are subject to representation upon the demand of authorized body of the country into which medicine is imported (further - Administrative regulations), establish terms and the sequence of ministerial procedures (actions) of the Ministry of Industry and Trade of the Russian Federation, order of interaction of its structural divisions, their officials, including with other federal bodies of the government by provision of the state service (further - the state service).

Circle of applicants

2. Applicants on receipt of the state service are legal entities, the performing activities for production of medicines or the organization - the applicant acting on behalf of the producer (further - the applicant), filed petition for provision of the state service (further - the statement).

Requirements to procedure for informing on provision of the state service

3. Location of the Ministry of Industry and Trade of the Russian Federation: Kitaygorodsky Proyezd, 7, p. 1, Moscow.

Postal address of the Ministry of Industry and Trade of the Russian Federation: Minpromtorg of Russia, Kitaygorodsky Proyezd, 7, p. 1, Moscow, 109074.

The official site of the Ministry of Industry and Trade of the Russian Federation on the information and telecommunication Internet: http://www.minpromtorg.gov.ru, http://www.минпромторг.рф.

E-mail address of the Ministry of Industry and Trade of the Russian Federation: e-mail: pr@mte.gov.ru.

Working schedule of the Ministry of Industry and Trade of the Russian Federation (including responsible structural division of the Ministry of Industry and Trade of the Russian Federation):

Phone of the Ministry of Industry and Trade of the Russian Federation for receipt of references concerning acceptance of correspondence: +7 (495) 539-21-87,

Phones of the Ministry of Industry and Trade of the Russian Federation for receipt of references concerning provision of the state service: (495) 632-87-00; (495) 632-88-88 (additional 3516,2658,2690,2750); (495) 632-88-70; (495) 632-83-99; (495) 632-89-37.

Phone calls from applicants concerning informing on procedure for provision of the state service are received according to the working schedule of the Ministry of Industry and Trade of the Russian Federation:

Monday, Tuesday, environment, Thursday - from 9:00 till 18:00;

Friday - from 9:00 till 16:45.

4. On the website of the federal state information system "Single Portal of the State and Municipal Services (Functions)" on the e-mail address on the Internet: www.gosuslugi.ru (further - the Portal) is placed the following information:

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;

4) results of provision of the state service, procedure for submission of the document which is result of provision of the state service;

5) the exhaustive list of the bases for suspension or refusal in provision of the state service;

6) the amount of the state tax collected for provision of the state service;

7) about the applicant's right to pre-judicial (extrajudicial) appeal of actions (failure to act) and the decisions made (performed) during provision of the state service;

8) the forms of statements (notifications, messages) used by provision of the state service.

Information on the Portal on procedure and terms of provision of the state service based on the data containing in the federal state information system "Federal Register of the State and Municipal Services (Functions)" is provided to the applicant free of charge.

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