Romania

Pharmacovigilance in Romania is regulated by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) under EU legislation and EU GVP. The MAH must maintain an EU/EEA QPPV and PSMF and meet EudraVigilance, PSUR, RMP, signal-management and inspection obligations. A separate Romanian national contact is not automatically mandatory, but NAMMDR may request one for national pharmacovigilance matters; that person reports to the EU QPPV. 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.