Azerbaijan

Pharmacovigilance activities in Azerbaijan are regulated by the Analytical Expertise Center (AEC) of the Ministry of Health under Cabinet of Ministers Resolution No. 503 and the national Good Pharmacovigilance Practice requirements. The MAH must establish a pharmacovigilance system, appoint a qualified person responsible for pharmacovigilance in Azerbaijan, maintain an accessible Pharmacovigilance System Master File (PSMF), report domestic adverse reactions to the AEC within 15 calendar days, submit periodic safety reports according to the statutory schedule, provide an RMP in the specified situations or when requested, and maintain signal-management, risk-based audit and record-retention arrangements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.