Belgium

Pharmacovigilance activities in Belgium are regulated by the Federal Agency for Medicines and Health Products (FAMHP) and governed by EU pharmacovigilance legislation and EU GVP. In addition to the EU QPPV and PSMF requirements, every MAH or registration holder in Belgium must appoint and notify the FAMHP of a local pharmacovigilance contact person, including for centrally authorised products. The local contact must be continuously available through an appropriate back-up system and able to communicate with the EU QPPV; one local contact is required per PSMF. EU requirements for EudraVigilance reporting, PSURs, RMPs, signal management and inspections also 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.