Armenia

Pharmacovigilance in Armenia is overseen by the Ministry of Health, with national adverse-reaction monitoring performed by the Scientific Centre of Drug and Medical Technology Expertise. National requirements, including Ministry of Health Order No. 312-N of 18 October 2024, apply together with the EAEU Good Pharmacovigilance Practice Rules. The MAH must maintain a pharmacovigilance system, have a QPPV who resides and performs the role in an EAEU Member State, maintain an accessible PSMF and fulfil applicable ICSR, PSUR/PBRER, RMP, signal-management, audit and inspection obligations. The EAEU pharmacovigilance framework also addresses the qualified person, pharmacovigilance system master file, ICSR reporting, periodic safety reports, risk-management plans, signal management, audits and inspections; the MAH must verify national implementation and submission channels. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.