Germany participates in the EU pharmacovigilance system through the Federal Institute for Drugs and Medical Devices (BfArM) and, for biological medicinal products within its remit, the Paul-Ehrlich-Institut (PEI).
Core official resources
- BfArM pharmacovigilance — post-authorisation safety information and pharmacovigilance resources.
- BfArM adverse-reaction reporting form — official ADR reporting information.
- Joint BfArM/PEI online reporting portal — national portal for suspected adverse reactions.
- Paul-Ehrlich-Institut — competent authority for vaccines and specified biological medicinal products.
Practical use
For MAHs, German ICSRs are handled within the EU EudraVigilance framework. The national BfArM/PEI reporting infrastructure is particularly relevant for understanding locally reported cases, safety communications and authority responsibilities.