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Ministry of Justice

Russian Federation

On July 15, 2016 No. 42874

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

of December 31, 2015 No. 4368

About approval of Administrative regulations of the Ministry of Industry and Trade of the Russian Federation on provision of the state service in issue of the document containing data on the stages of engineering procedure of production of medicine for medical application performed in the territory of the Eurasian Economic Union

According to the Rules of development and approval of administrative regulations of provision of the state services approved by the order of the Government of the Russian Federation of May 16, 2011 No. 373 (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, to No. 5, of the Art. 506), I order:

1. Approve the enclosed Administrative regulations of the Ministry of Industry and Trade of the Russian Federation on provision of the state service in issue of the document containing data on the stages of engineering procedure of production of medicine for medical application performed in the territory of the Eurasian Economic Union.

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

Vr.i.o. Minister

G. S. Nikitin

Approved by the Order of the Ministry of Industry and Trade of the Russian Federation of December 31, 2015, No. 4368

Administrative regulations of the Ministry of Industry and Trade of the Russian Federation on provision of the state service in issue of the document containing data on the stages of engineering procedure of production of medicine for medical application performed in the territory of the Eurasian Economic Union

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Ministry of Industry and Trade of the Russian Federation on provision of the state service in issue of the document containing data on the stages of engineering procedure of production of medicine for medical application performed in the territory of the Eurasian Economic Union (further - Administrative regulations and the state service respectively) establish terms and the sequence of ministerial procedures (actions) of the Ministry of Industry and Trade of the Russian Federation (further - Minpromtorg of Russia), order of interaction between structural divisions, their officials, and also interactions of Minpromtorg of Russia with applicants, public authorities of the Russian Federation.

Circle of applicants

2. Applicants on receipt of the state service are the legal entities performing activities for production of medicines for medical application in the territory of the Eurasian Economic Union, or the organization applicant operating on behalf of the producer (further - the applicant), which filed petition for provision of the state service (further - the statement).

Requirements to procedure for informing the state service

3. Location of Minpromtorg of Russia:

109074, Moscow, Kitaygorodsky Proyezd, 7.

The postal address for the direction of correspondence on questions of provision of the state service:

109074, Moscow, Kitaygorodsky Proyezd, 7, Minpromtorg of Russia.

Location of expedition of Minpromtorg of Russia:

109074, Moscow, Kitaygorodsky Proyezd, 7.

Official site of Minpromtorg of Russia: http://www.minpromtorg.gov.ru, http://www.минпромторг.рф.

Working hours of Minpromtorg of Russia (Moscow time):

 

Monday

9:00 - 12:00;

12:45 - 18:00

Tuesday

9:00 - 12:00;

12:45 - 18:00

Environment

9:00 - 12:00;

12:45 - 18:00

Thursday

9:00 - 12:00;

12:45 - 18:00

Friday

9:00 - 12:00;

12:45 - 16:45

Saturday

The day off


Sunday

The day off


 

Phone of service desk of Minpromtorg of Russia: +7 (495) 539-21-87, e-mails: pr@mte.gov.ru.

Phones of Minpromtorg of Russia for consultations concerning provision of the state service: (495) 632-87-00; (495) 632-89-37; (495) 539-21-29; (495) 647-87-37; (495) 632-85-89.

Phone calls from applicants concerning informing on procedure for provision of the state service are received according to the working schedule of Minpromtorg of Russia:

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 information and telecommunication Internet: www.gosuslugi.ru (further - the Portal) is placed the following information on provision of the state service:

the regulatory legal acts containing the regulations regulating provision of the state service;

the text of these Administrative regulations with appendices;

list of the documents necessary for provision of the state service;

requirements to submission of documents electronically;

the postal address, the address of the official site of Minpromtorg of Russia and the e-mail address to which reception of applications and documents of applicants for provision of the state service is performed;

the working schedule of expedition and acceptance of applicants in Minpromtorg of Russia;

the bases for refusal in documents acceptance and provision of the state service;

procedure for informing on the course of provision of the state service;

data on telephone numbers for receipt of information on the state service;

information on procedure for giving and consideration of the claim to decisions, actions (failure to act) of Minpromtorg of Russia, and also officials of Minpromtorg of Russia, actionees of the ministerial procedures connected with provision of the state service;

samples of the documents used by Minpromtorg of Russia in the course of provision of the state service;

models of execution of statements for provision of the state service;

other information concerning provision of the state service.

5. Information specified in item 4 of these Administrative regulations and also information on the issued documents containing data on stages of engineering procedure of production of medicine for medical application and reference materials concerning provision of the state service is posted on the official site of Minpromtorg of Russia.

6. For receipt of information on procedure for provision of the state service, including electronically, the applicant addresses to Minpromtorg of Russia:

by phones of Minpromtorg of Russia specified in Item 3 presents of Administrative regulations;

in writing (mail, fax connection) to the address of Minpromtorg of Russia specified in Item 3 presents of Administrative regulations;

to the e-mail address, through the official site of Minpromtorg of Russia or through the Portal.

7. Informing on the course of provision of the state service is performed by officials of Minpromtorg of Russia in case of the personal address of applicants, with use of means of the information and telecommunication Internet, mail, telephone communication, by e-mail.

Consultations (reference) concerning provision of the state service are performed by the officials of Minpromtorg of Russia responsible for consideration of the application about provision of the state service and documents of the applicant.

8. When informing on the course of provision of the state service the following information is provided:

about the entering number at which the statement for provision of the state service and documents of the applicant are registered;

about phone number and surname, name, middle name (in the presence) the official of Minpromtorg of Russia responsible for consideration of the application about provision of the state service and documents of the applicant;

about the course of consideration of the application about provision of the state service and documents of the applicant;

about the made decision according to the specific statement for provision of the state service.

Time of conversation shall not exceed 5 minutes.

Other information is provided only based on the corresponding request in writing (mail, fax connection, e-mail to the address of Minpromtorg of Russia) or through the Portal.

9. When informing on the course of provision of the state service in written addresses the answer to the address goes to the address (post or electronic) specified by the applicant, in time, which is not exceeding five working days from registration date in Minpromtorg of Russia of the address.

10. In case of responses to phone calls and oral addresses officials of Minpromtorg of Russia in detail and in polite (correct) form inform addressed on the questions interesting them.

The response to phone call shall begin with specifying of surname, name, middle name and position of person who received phone call.

11. In case of impossibility of the official who received call to answer independently the questions posed, the phone number on which it is possible to obtain necessary information shall be told the applicant, or opportunity to leave the coordinates for the subsequent informing the applicant on the questions posed is offered.

II. Standard of provision of the state service

Name of the state service

12. The state service in issue of the document containing data on the stages of engineering procedure of production of medicine for medical application performed in the territory of the Eurasian Economic Union (further - the document of the joint venture).

The name of the federal executive body providing the state service

13. The state service is provided by Minpromtorg of Russia. The structural division of Minpromtorg of Russia responsible for provision of the state service, the Development department of the pharmaceutical and medical industry is (further - Department).

14. By provision of the state service it is forbidden to demand from the applicant of implementation of actions the, including coordination necessary for receipt of the state service and connected with the appeal to other state bodies and the organizations, except for receipts of the services included in the list of services which are necessary and obligatory for provision of the state services, No. 352 approved by the order of the Government of the Russian Federation of May 6, 2011 (The Russian Federation Code, 2011, No. 20, of Art. 2829; 2012, No. 14, Art. 1655; No. 36, Art. 4922; 2013, No. 33, Art. 4382; No. 49, Art. 6421; No. 52, Art. 7207; 2014, No. 21, Art. 2712; 2015, No. 50, Art. 7165, Art. 7189).

Description of result of provision of the state service

15. Provisions of the state service are result:

a) issue (refusal in issue) the document of the joint venture;

b) issue of the duplicate of the document of the joint venture.

The term of provision of the state service, including taking into account need of the appeal to the organizations participating in provision of the state service, the term of suspension of provision of the state service if the possibility of suspension is stipulated by the legislation the Russian Federation, the term of issue (direction) of the documents which are result of provision of the state service

16. Decision making term about issue (about refusal in issue) the document of the joint venture cannot exceed thirty working days from receipt date in Minpromtorg of Russia of the issued application and complete set of the documents attached to it. Time necessary for the direction Minpromtorg of Russia of request about submission of required materials and submission of the answer by the applicant, is not considered in case of calculation of term of issue of the document of the joint venture.

17. The term of issue to the applicant of the duplicate of the document of the joint venture cannot exceed five working days from receipt date in Minpromtorg of Russia of properly issued application.

The list of the regulatory legal acts governing the relations arising in connection with provision of the state service

18. The list of the regulatory legal acts governing the relations arising in connection with provision of the state service:

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. 7578; 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, Art. 4367, Art. 4388, No. 51, Art. 7245; 2016, No. 1, Art. 9; No. 23, Art. 3287);

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