Kazakhstan

Pharmacovigilance activities in Kazakhstan are regulated by the Medical and Pharmaceutical Control Committee and supported by the National Center for Expertise of Medicines and Medical Devices under national legislation and the EAEU Good Pharmacovigilance Practice Rules. The MAH must operate a pharmacovigilance system, appoint an EAEU QPPV who resides and performs the role in an EAEU Member State, maintain an accessible PSMF and comply with national/EAEU ICSR, PSUR/PBRER, signal-management and RMP requirements. A separate Kazakhstan local contact should only be stated where specifically requested by the competent authority or supported by current national instructions. 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.