Veterinarians and pharmaceutical companies are obligated to report suspected cases of medicine-related adverse events.
As of 28 January 2022, Regulation (EU) 2019/6 of the European Parliament on veterinary medicinal products (EU TAM Regulation) will be applied in all Member States of the Union. This means that marketing authorisation holders of veterinary medicinal products (MAH) must report all adverse event (AE) reports they receive directly to the European database EVVet3. The reporting channel for marketing authorisation holders via the national authorities is no longer provided for.
These reports on medicine-related adverse events should be communicated to the following competent authorities:
- Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL)
The Federal Office of Consumer Protection and Food Safety is the national authority responsible for the authorisation and registration of veterinary drugs in Germany.
- Paul-Ehrlich-Institut (PEI)
The Paul-Ehrlich-Institut (PEI) in Langen is responsible for the authorisation and batch releases of sera and vaccines for animal use.
- German Veterinarians' Association (German only)
The German Veterinarians’ Association (Bundestierärztekammer) also collects reports and sends them to the competent authority.
- The European Commission
The European Commission is responsible for genetically engineered and innovative medicines on the European level, whereas the European Medicines Agency (EMA) carries out scientific evaluations.