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Main  >  News  >  Changes to the calculation of fees for inspection for compliance with GMP rules have been developed

Changes to the calculation of fees for inspection for compliance with GMP rules have been developed

The Ministry of Industry and Trade of Russia has developed amendments to Order No. 3021 dated August 15, 2019 “On Approval of the Methodology for Determining the Amount of Fees for the Provision of Services for the Inspection of Manufacturers of Medicines (for Medical Use) Produced Outside the Russian Federation, for Compliance with the Requirements Manufacturing Practice (GMP) for the purpose of issuing conclusions on the compliance of the manufacturer of medicinal products with the requirements of GMP rules and the maximum fee for the provision of the specified service. " The draft document has been published on the regulation.gov.ru portal, its discussion will last until November 13 of this year.

The change in the determination of the size of the fee for inspection for GMP compliance was developed due to the fact that by the Decree of the Government of the Russian Federation dated September 5, 2020 No. 1361, amendments were made to the Rules for organizing and conducting inspections of drug manufacturers for compliance with the requirements of GMP rules and issuing appropriate conclusions, and a mechanism was established for the provision of a corrective and preventive action plan (CAPA) and a report on its implementation by foreign manufacturers of medicinal products for the possibility of eliminating the identified inconsistencies before deciding to issue (or refuse to issue) an opinion on the manufacturer's compliance with GMP rules.

The draft order assumes that in the case of the provision of the CAPA assessment service, the amount of the fee must be calculated in accordance with the specified Methodology approved by the authorized body and must not exceed the maximum amount of the fee approved by the authorized body.

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