On 8 April 2025, the first-ever European Veterinary Medicine Safety Day (#VetMedSafetyDay) will take place, a Europe-wide initiative organised by the European Medicines Agency (EMA), the national medicines authorities of the European Economic Area (EEA), and the Federation of Veterinarians of Europe (FVE). The aim of the annual action day is to raise awareness among veterinarians and animal keepers of the importance of reporting adverse events that occur after the use of veterinary medicinal products. Reporting suspected adverse reactions is an important component of pharmacovigilance in the field of veterinary medicine. The reports help to further improve the safety and efficacy of veterinary medicinal products. The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, assesses reports submitted in Germany on immunological veterinary medicinal products and thus actively contributes to the safety of these medicinal products.
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Marketing authorisation of veterinary medicinal products requires that extensive studies on the safety and efficacy of the medicinal product be conducted in advance. However, continuous monitoring is essential, even after authorisation: some adverse events that are very rare or only occur in certain breeds or animal groups can only be detected if veterinary medicinal products are used under practical conditions. Reports of suspected adverse events can help to identify these previously unknown risks. In veterinary medicine, an adverse event is any adverse reaction in an animal that occurs after the use of a veterinary medicinal product. A lack of efficacy of the medicinal product, negative environmental effects, and events that occur in a human after the intended or unintended use of a veterinary medicinal product should also be reported if observed. All reports of suspected adverse events are systematically recorded in the EudraVigilance database of the EMA.
The Paul-Ehrlich-Institut is responsible in Germany for the authorisation and batch release of vaccines and other immunological medicinal products for use in animals and the monitoring of the safety of these medicinal products. Concurrently, the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) is responsible for the authorisation or registration and monitoring of the safety of all other veterinary medicinal products in Germany. Both authorities evaluate suspected adverse event reports to determine whether a causal relationship between the use of the veterinary medicinal product and the reported events is possible or probable. Veterinary medicine experts investigate any patterns that emerge due to frequent reports. Depending on the severity of the symptoms and the conditions under which they have occurred, the experts may be able to take measures to minimise risk.
Veterinarians are obliged to report suspected adverse events after the use of a medicinal product in accordance with their professional code. Pharmaceutical companies are legally obliged to report in accordance with the European Veterinary Medicinal Products Regulation (EU) 2019/6 and the Animal Vaccine Regulation (TierImpfStV 2006). Animal keepers can also report suspected adverse events directly to the competent authorities. The Paul-Ehrlich-Institut and the BVL maintain an online portal for veterinarians and animal keepers to report adverse events in the field of veterinary medicine. Each report received makes an important contribution to risk detection and minimisation.
Updated: 08.04.2025
