On July 1st, 2020, Germany has assumed the Presidency of the Council of the European Union (EU) for the following six months and sets political priorities for Europe. On the occasion of the German Council Presidency, the Federal Office of Consumer Protection and Food Safety with the Department for Veterinary Drugs has increased its commitment in the field of EU veterinary medicinal products regulation and for the availability of veterinary drugs. The BVL amongst others organises meetings of European pharmaceutical bodies and committees, which are dedicated to the current strategies of veterinary drugs supply, approval processes and crisis management in Europe.

On October 20 and 21, in cooperation with the Paul Ehrlich Institute (PEI), the BVL hosted the informal meeting of the Committee for Veterinary Medicinal Products (CVMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv). Both meetings took place virtually.

The CVMP dealt with Vaccine antigen master files (VAMF) and Vaccine platform technology master files (PTMF). Furthermore, the “3R” principle in animal testing (replace, reduce, refine) and its implementation in current legislation was addressed. The coordination group (CMDv) was primarily dedicated to the upcoming application of the new European Regulation on Veterinary Medicinal Products (Regulation (EU) 2019/6) in January 2022 and the associated changes in the regulation of veterinary medicinal products. Among other topics, the upcoming harmonisation of the Summary of Product Characteristics (SPC), the handling of future variation procedures and the IT systems to be established were discussed. In the area of pharmacovigilance, the upcoming tasks of the coordination group were explored.

More than 50 experts from the European Union successfully attended the virtual format and participated actively in the subsequent discussions.

Year of issue 2020
Date 03.11.2020

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