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Main  >  News  >  A methodology for calculating fees for conducting inspections for compliance with GMP EAEU is presented

A methodology for calculating fees for conducting inspections for compliance with GMP EAEU is presented

The Ministry of Industry and Trade of Russia has developed a draft order on approval of the methodology for determining the amount of payment for the provision of services for conducting pharmaceutical inspections of drug manufacturers (for medical use) for compliance with the requirements of the rules of good manufacturing practice of the Eurasian Economic Union (GMP EAEU) in relation to a drug declared for registration and intended for circulation on the common market of medicines within the EAEU, as well as a non-resident manufacturer and the maximum amount of payment for the provision of this service. The draft document has been published on the regulation.gov.ru portal, its discussion will last until November 13 of this year.

By the developed document, the federal budgetary institution "State Institute of Medicines and Good Practices" (FBU "GILS and NP") is authorized to conduct:

• pharmaceutical inspections of the production of medicines for medical use located on the territory of the Russian Federation for compliance with the requirements of the EAEU GMP rules;

• pharmaceutical inspections of the production of medicines for medical use located outside the Russian Federation for compliance with the requirements of the EAEU GMP rules, including jointly with the pharmaceutical inspectorates of another EAEU member state.

Control over the execution of the order is entrusted to the First Deputy Minister of Industry and Trade of the Russian Federation S.A. Tsyba.

The described service is provided for by the Decree of the Government of the Russian Federation dated September 15, 2020 No. 1446 "On the determination of the federal executive body authorized to implement the decision of the Council of the Eurasian Economic Commission No. 83 dated November 3, 2016 and the decision of the Council of the Eurasian Economic Commission No. 82, as well as on amendments to some acts of the Government of the Russian Federation ”.

 

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