Veterinarians and pharmaceutical companies are obligated to report suspected cases of medicine-related adverse events.
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.