Germany

Pharmacovigilance in Germany is supervised by the Federal Institute for Drugs and Medical Devices (BfArM) and, for vaccines and certain biological medicinal products, the Paul-Ehrlich-Institut (PEI) under EU legislation and EU GVP. The MAH must appoint an EU/EEA QPPV, maintain an EU/EEA PSMF and meet EU ICSR, PSUR and RMP obligations. German law additionally requires notification of a national Graduated Plan Officer (Stufenplanbeauftragter) for relevant nationally authorised products; an MAH holding only centrally authorised products may rely on the EU QPPV for this function. Pharmacovigilance inspections apply. As an EU/EEA jurisdiction, the EU pharmacovigilance framework applies to the EU QPPV and Union PSMF, EudraVigilance ICSR reporting, applicable PSURs, RMPs, signal management, quality-system audits and competent-authority inspections. MAHs should also check current national submission channels, contact arrangements and language requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Difference in QPPV Nomination Between EU and KSA; PSMF Maintenance: Concept and Importance in Pharmacovigilance.