Russia

Pharmacovigilance in Russia is supervised by Roszdravnadzor under Russian requirements and the EAEU GVP Rules. The MAH must maintain a pharmacovigilance system, appoint an EAEU QPPV who resides and operates in an EAEU Member State, keep an accessible PSMF and fulfil national/EAEU ICSR, PSUR/PBRER, RMP, signal-management, audit and inspection obligations. A separate Russian local contact should be stated only where required by the current national procedure or authority, rather than as a universal EAEU rule. 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.