The Paul-Ehrlich-Institut met with the Federal Association for Animal Health (Bundesverband für Tiergesundheit, BfT) for their annual dialogue on 11 November 2025 and exchanged views on current regulatory developments in the field of veterinary medicinal products. The Paul-Ehrlich-Institut is responsible for immunological veterinary medicinal products, immunotherapeutics, and animal allergens in Germany and also evaluates them at the European Medicines Agency (EMA) with regard to centralised marketing authorisations. The BfT represents the leading manufacturers of veterinary medicinal products and feed additives in Germany. Regulatory support for the development of immunological veterinary medicinal products, immunotherapeutics, and animal allergen products ensures the quality, safety, and efficacy of these veterinary medicines. The ongoing exchange between the Paul-Ehrlich-Institut as the competent higher federal authority and veterinary medicinal product manufacturers thus makes an important contribution to preserving the health of livestock and pets.
Source: Paul-Ehrlich-Institut
Discussion topics at the meeting between experts from the Paul-Ehrlich-Institut and the BfT included their recent experiences with the application and ongoing development of the EU Veterinary Medicinal Products Regulation, which has been in force since 28 January 2022, as well as the newly submitted draft law amending the Animal Health Act, the Veterinary Medicinal Products Regulation, and the Animal Vaccine Ordinance to adapt the national regulations to the EU Regulation. New developments regarding the European Union Product Database (UPD) and the pharmacovigilance databases, including the publicly accessible databases, were also discussed. These databases function as a central source of information on all authorised veterinary medicinal products in the Member States of the European Union (EU) and the European Economic Area (EEA). The Paul-Ehrlich-Institut is actively involved in the ongoing development of the databases.
Experts in the field of veterinary medicine at the Paul-Ehrlich-Institut are represented on various European committees of the EMA and the European Directorate for the Quality of Medicines & HealthCare (EDQM), which deal with issues relating to immunological veterinary medicinal products, and on the Coordination Group for the Mutual Recognition of Veterinary Medicinal Products and Decentralised Procedures (CMDv) and the Standing Committee on Veterinary Vaccination (Ständige Impfkommission Veterinärmedizin, StIKo Vet). The representatives reported to the BfT on new developments and their activities on these committees. Questions were discussed regarding vaccine monographs and guidelines, the recording of adverse events after the use of veterinary medicinal products, vaccination recommendations, the development of new vaccines, and on herd-specific vaccines. A presentation was also made of an ongoing research project to develop an in vitro method for batch testing in the field of veterinary medicine at the Paul-Ehrlich-Institut. The official batch testing and release of immunological veterinary medicinal products, one of the Paul-Ehrlich-Institut's tasks, was another topic of discussion. The Institute tested almost 2,500 batches of immunological veterinary medicinal products in 2024. The Paul-Ehrlich-Institut's testing activities contribute to a reliable supply of safe and effective immunological veterinary medicinal products. The BfT reported on the situation regarding the ongoing procedure to restrict perfluoroalkyl and polyfluoroalkyl substances (PFAS) and on other relevant restriction procedures (siloxanes, formalin) that could also affect the veterinary medicinal product sector.
Updated: 17.11.2025
