At their annual dialogue on 12 December 2024, the Paul-Ehrlich-Institut exchanged views with the Federal Association for Animal Health (Bundesverband für Tiergesundheit, BfT) on current regulatory developments in the field of veterinary medicinal products. The Paul-Ehrlich-Institut is responsible for immunological veterinary medicinal products and immunotherapeutics 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 and immunotherapeutics 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
During the meeting, experts from the BfT and the Paul-Ehrlich-Institut discussed topics such as their experiences with the application of the EU Veterinary Medicinal Products Regulation, which has been in force since 28 January, 2022, and the proposals for the corresponding revision of national legislation. New developments regarding the European Union Product Database (UPD) and the Pharmacovigilance Database 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 these 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 Standing Veterinary Vaccination Commission (Ständige Impfkommission Veterinärmedizin, StIKo Vet). The experts reported to the BfT on their activities on these committees. An ongoing research project in the field of veterinary medicine at the Paul-Ehrlich-Institut was also presented. Another topic discussed at the meeting was the further development of pharmacovigilance in the veterinary sector and how the reporting system for recording adverse events after the use of veterinary medicinal products could be improved in the future. Ensuring the safety of veterinary medicinal products is a common concern for the industry and public authorities. The federal batch testing and release of immunological veterinary medicinal products is one of the Paul-Ehrlich-Institut's tasks. The Institute tested over 2,400 batches of immunological veterinary medicinal products in 2023. The Paul-Ehrlich-Institut's testing activities contribute to a reliable supply of safe and effective immunological veterinary medicinal products.
Updated: 19.12.2024
