Belarus

Pharmacovigilance in Belarus is overseen by the Ministry of Health and supported by the Center for Examinations and Tests in Health Service (RCETH). National legislation applies together with the EAEU Good Pharmacovigilance Practice Rules. The MAH must maintain a pharmacovigilance system, appoint a QPPV who resides and performs the role in an EAEU Member State, keep an up-to-date and accessible PSMF, and meet EAEU and Belarusian requirements for adverse-reaction reporting, PSUR/PBRER and RMP submission where applicable, signal management, audits and pharmacovigilance inspections. The competent authority may additionally require a national-level pharmacovigilance contact. 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.