On October 1, 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. Simultaneously, the Special Fee Ordinance of the Federal Ministry of Health for individually attributable services in its area of responsibility (Special Fee Ordinance BMG - BMGBGebV – German only) of September 24, 2021 (Federal Law Gazette I p. 4391) as well as the Special Fee Ordinance of the Federal Ministry of Food and Agriculture for individually attributable public services in its area of responsibility (Special Fee Ordinance BMEL - BMELBGebV - German only) of July 13, 2021 (Federal Law Gazette I p. 2874) entered into force.

Section 4 Table 2 BMGBGebV contains the fees that are to be charged in the course of notifications of changes/variations in accordance with Regulation (EC) 1234/2008. Section 3 Table 2 BMGBGebV contains the fees to be charged for approval procedures and all other fee-related facts according to the Medicinal Products Act (AMG), except for the fees for activities in the context of pharmacovigilance. These can be found in Section 14 of the BMELBGebV.

These 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 October 1, 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 applicable AMGKostV.

Consequences of the amendment of the law concerning veterinary medicinal products

Since January 28, 2022, Regulation (EU) 2019/6 of the European Parliament and of the Council of December 11, 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0006&from=DE) applies. At the same time, the law on the sale of veterinary medicinal products and on the implementation of EU regulations relating to veterinary medicinal products (Tierarzneimittelgesetz - TAMG) of September 27, 2021 (https://www.gesetze-im-internet.de/tamg/index.html - German only) entered into force .

As a result, the fee items in Section 3 Table 2 and Section 4 Table 2 of the BMGBGebV and Section 14 of the BMELBGebV had to be adjusted. The corresponding ordinance procedures have been completed with the enactment of the ordinance on the reorganisation of veterinary medicinal product regulations and on the adaptation of legal ordinances to the veterinary medicinal product law (Federal Law Gazette Volume 2022 Part I No. 25, issued on 18.07.2022, page 1102).

The updated fee regulations concerning veterinary medicinal products can now be found in Section 6a Table 1 of the BMGBGebV as well as in Section 14 of the BMELBGebV and came into force on 19.07.2022. The current versions of the ordinances can be found under the following links "BMGBGebV (German)" and "BMELBGebV (German)". The previously applicable ordinance texts can be found under the following links "BMGBGebV old version (German)" and "BMELBGebV old version (German)". 

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