On 1 October 2021, the Fee Regulation for the Authorisation and Registration of Medicinal Products by the Federal Institute for Drugs and Medical Devices and the Federal Office for Consumer Protection and Food Safety (AMG Fee Regulation - AMGKostV) expired and was replaced by two new Special Fee Ordinances: The "Besondere Gebührenverordnung des Bundesministeriums für Gesundheit für die individuell zurechenbaren Leistungen in seinem Zuständigkeitsbereich (Besondere Gebührenverordnung BMG – BMGBGebV) vom 24 September 2021 (Federal Law Gazette. I p. 4391) (https://www.gesetze-im-internet.de/bmgbgebv/index.html)" and the "Besondere Gebührenverordnung des Bundesministeriums für Ernährung und Landwirtschaft für individuell zurechenbare öffentliche Leistungen in dessen Zuständigkeitsbereich (Besondere Gebührenverordnung BMEL - BMELBGebV) vom 13. Juli 2021 (Federal Law Gazette I p. 2874) (https://www.gesetze-im-internet.de/bmelbgebv/index.html)" entered into force on 1 October 2021.

Section 4 Table 2 BMGBGebV contains the fees to be charged in the course of notifications of amendments according to Regulation (EC) 1234/2008. Section 3 Table 2 BMGBGebV contains the fees to be charged for marketing authorisation procedures and other fee-relevant individually attributable services according to the Medicinal Products Act (Arzneimittelgesetz – AMG) except for the fees for activities within the scope of pharmacovigilance. These can be found in section 14 of the BMELBGebV.

The above Special Fee Ordinances apply to all individually attributable services (in particular applications and notifications) received by the Federal Office of Consumer Protection and Food Safety (BVL) from 1 October 2021. For chargeable services that were applied for or started before the above-mentioned Special Fee Ordinances came into force on October 1, 2021, but for which the provision of services has not yet been completed at this point in time, transitional provisions regulate the further application of the previously valid AMGKostV.

Year of issue 2021
Date 06.10.2021

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