Kyrgyzstan

Pharmacovigilance activities in Kyrgyzstan are overseen by the Department of Medicines and Medical Devices under the Ministry of Health and are governed by national legislation together with the EAEU Good Pharmacovigilance Practice Rules. The MAH must maintain 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 applicable ICSR, PSUR/PBRER, signal-management and RMP obligations. Current national materials also provide for a pharmacovigilance contact person alongside the qualified person; the applicable appointment/notification arrangement should be confirmed for the product route. 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.