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

of May 26, 2016 No. 1714

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 conclusions about compliance of producers of medicines for medical application to requirements of rules of proper production practice

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; No. 49, Art. 6928; 2015, No. 1, Art. 67, Art. 72; No. 10, Art. 1393; No. 29, Art. 4342, Art. 4376; 2016, No. 7, the Art. 916), 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 Ministry of Industry and Trade of the Russian Federation on provision of the state service in issue of the conclusions about compliance of producers of medicines for medical application to requirements of Rules of proper production practice.

2. To impose control of execution of this order on the First Deputy Minister of Industry and Trade of the Russian Federation S. A. Tsyba.

Approved by the Order of the Ministry of Industry and Trade of the Russian Federation of May 26, 2016, No. 1714

Administrative regulations of the Ministry of Industry and Trade of the Russian Federation on provision of the state service in issue of the conclusions about compliance of producers of medicines for medical application to requirements of rules of proper production practice

I. General provisions

Subject of regulation of these Administrative regulations

1. The administrative regulations of provision by the Ministry of Industry and Trade of the Russian Federation of service in issue of the conclusions about compliance of producers of medicines for medical application to requirements of Rules of proper production practice (further - Administrative regulations and the state service respectively) establish terms and the sequence of ministerial procedures (actions) performed by the Ministry of Industry and Trade of the Russian Federation, order of interaction between structural divisions of the Ministry of Industry and Trade of the Russian Federation, their officials with public authorities by provision of the state service, including with the Federal budgetary institution "The State Institute of Medicines and Ought the Practician" subordinated to the Ministry of Industry and Trade of the Russian Federation (further - authorized institution).

Circle of applicants

2. Applicants on receipt of the state service are legal entities: producers of medicines for medical application which production is performed in the Russian Federation (further - the producer) or producers of medicines for medical application which production is performed outside the Russian Federation (further - the foreign producer), or their authorized representatives.

Requirements to procedure for informing on provision of the state service

3. Information on the location, telephone numbers for enquiries, including number of phone answerphone, addresses of the official site, e-mail and (or) form of feedback, the schedule (mode) of work of the Ministry of Industry and Trade of the Russian Federation, is placed in the federal state information system "Federal Register of the State and Municipal Services (Functions)", in the federal state information system "Single Portal of the State and Municipal Services (Functions)", on the official site of the Ministry of Industry and Trade of the Russian Federation on the Internet to the address: http://www.minpromtorg.gov.ru, http://www.минпромторг.рф (further - the official site of the Ministry).

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.

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;

9) the list of the regulatory legal acts governing the relations arising in connection with provision of the state service with indication of their details and sources of official publication.

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.

The information access about terms and procedure for provision of the state service is performed without accomplishment by the applicant of any requirements, including without use of the software which installation on technical means of the applicant requires the conclusion of license or other agreement with the owner of the software providing collection of payment, registration or authorization of the applicant or provision of personal data by it.

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