Immunological veterinary medicinal products, such as animal vaccines, and other veterinary medicinal products, such as immunotherapeutics, are important for the health of livestock and pets. However, these products also contribute to the protection of humans within the framework of the one-health concept by protecting against infectious agents that can be transmitted from animals to humans. Regulatory support for the development of immunological veterinary medicinal products ensures the quality, safety, and efficacy of these medicines. The Paul-Ehrlich-Institut, which is responsible for immunological veterinary medicinal products in Germany and evaluates them at the European Medicines Agency with regard to authorisation, exchanged experiences with the Federal Association for Animal Health (Bundesverband für Tiergesundheit, BfT) at their annual dialogue on current regulatory developments. The BfT represents the leading manufacturers of veterinary medicinal products and feed additives in Germany. The ongoing exchange between the regulatory authority and veterinary medicinal product manufacturers makes an important contribution to maintaining the health of pets and livestock.
During the meeting, experts from the BfT and the Paul-Ehrlich-Institut discussed topics such as their experiences with the new EU Veterinary Medicinal Products Regulation and the European Union Product Database (UPD). The UPD functions as a central source of information on all veterinary medicinal products authorised in the Member States of the European Union (EU) and the European Economic Area (EEA). The European Medicines Agency (EMA) has set up a website with information on veterinary medicinal products as well as the EU product database in cooperation with the Member States' pharmaceutical authorities and the European Commission. The Paul-Ehrlich-Institut is actively involved in the ongoing development of the database at the EMA.
Another meeting topic was pharmacovigilance in the veterinary sector and how the reporting system for recording adverse drug reactions in veterinary medicinal products could be improved in the future. Ensuring safety is a common concern for the industry and public authorities. Experts from the field of veterinary medicine at the Paul-Ehrlich-Institut are active on various European committees as well as on the Standing Veterinary Vaccination Commission (Ständige Impfkommission Veterinärmedizin, StIKo Vet). The experts reported on their activities to the BfT at the meeting. Current research projects from the field of veterinary medicine at the Paul-Ehrlich-Institut were also presented. In addition to medicinal product evaluation, the Institute's tasks include federal batch testing and release of immunological veterinary medicinal products. In 2022, the Paul-Ehrlich-Institut tested over 2,000 batches of immunological veterinary medicinal products. The Paul-Ehrlich-Institut's testing activities promote the reliable supply of safe and effective animal vaccines and therapeutics.
Updated: 09.12.2023
