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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 15, 2020 No. 1446

About determination of the federal executive body authorized on implementation of the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83 and the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 82, and also about introduction of amendments to some acts of the Government of the Russian Federation

The government of the Russian Federation decides:

1. Determine the Ministry of Industry and Trade of the Russian Federation the body authorized on implementation of the decision of Council of the Eurasian economic commission of November 3, 2016 No. 83 "About approval of Rules of conducting pharmaceutical inspections" regarding the organization and (or) conducting pharmaceutical inspections on compliance of production of medicines for medical application to requirements of Rules of proper production practice of the Eurasian Economic Union No. approved by the decision of Council of the Eurasian economic commission of November 3, 2016 77, and also on implementation of the decision of Council of the Eurasian economic commission of November 3, 2016 No. 82 "About approval of General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union" on ensuring reduction of quality systems of pharmaceutical inspectorate (regarding production of medicines for medical application) in compliance with provisions of the specified General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union.

2. Approve the enclosed changes which are made to acts of the Government of the Russian Federation.

3. Realization of the powers provided by this resolution is performed by the Ministry of Industry and Trade of the Russian Federation within the limiting Russian Federation established by the Government of number and the salary fund of his workers, and also budgetary appropriations provided in the federal budget on management and management in the established fields of activity.

4. To the Ministry of Foreign Affairs of the Russian Federation to notify the Eurasian economic commission on the authorized body determined by Item 1 of this resolution.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of September 15, 2020 No. 1446

Changes which are made to acts of the Government of the Russian Federation

1. In subitem 5.8.18 (1) the Regulations on the Ministry of Industry and Trade of the Russian Federation approved by the order of the Government of the Russian Federation of June 5, 2008 No. 438 "About the Ministry of Industry and Trade of the Russian Federation" (The Russian Federation Code, 2008, No. 24, Art. 2868; 2017, No. 36, of the Art. 5436) to replace the words "carrying out initiation" with the word "organization".

2. The list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and are provided by the organizations participating in provision of the state services No. 352 approved by the order of the Government of the Russian Federation of May 6, 2011 "About approval of the list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and are provided by the organizations participating in provision of the state services, and determination of the amount of payment for their rendering" (The Russian Federation Code, 2011, No. 20, Art. 2829; 2012, No. 14, Art. 1655; No. 36, Art. 4922; 2013, No. 49, Art. 6421; No. 52, Art. 7207; 2014, No. 21, Art. 2712; 2015, No. 50, Art. 7165, 7189; 2016, No. 31, Art. 5031; No. 37, Art. 5495; 2017, No. 8, Art. 1257; No. 28, Art. 4138; No. 32, Art. 5090; No. 40, Art. 5843; No. 42, Art. 6154; 2018, No. 16, Art. 2371; No. 27, Art. 4084; No. 40, Art. 6129; 2019, No. 5, Art. 390; No. 23, Art. 2943; No. 26, Art. 3460; No. 36, Art. 5022; No. 48, Art. 6852; 2020, No. 1, of the Art. 51) to add with Items 52 and 53 of the following content:

"52. Conducting pharmaceutical inspections of production of medicines for the medical application located in the territory of the Russian Federation on compliance to requirements of rules of proper production practice of the Eurasian Economic Union for the purpose of issue of the certificate (certificates) of compliance of the producer (producers) of medicines for medical application to requirements of rules of proper production practice of the Eurasian Economic Union for the medicine declared on registration and intended for the address in the total market of medicines within the Eurasian Economic Union <*>.

53. Conducting pharmaceutical inspections of production of medicines for the medical application located outside the Russian Federation on compliance to requirements of rules of proper production practice of the Eurasian Economic Union, including together with pharmaceutical inspectorates of other state member of the Eurasian Economic Union, for the purpose of issue of the certificate (certificates) of compliance of the producer (producers) of medicines for medical application to requirements of rules of proper production practice of the Eurasian Economic Union <*>.".

 

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