Bulgaria

Pharmacovigilance activities in Bulgaria are regulated by the Bulgarian Drug Agency (BDA) under EU pharmacovigilance legislation, EU GVP and the Medicinal Products in Human Medicine Act. The MAH must appoint an EU/EEA-based QPPV, maintain an EU/EEA PSMF and also designate a person established in Bulgaria to assist the QPPV, with the relevant details submitted to the BDA. EU requirements for EudraVigilance reporting, PSURs, RMPs, signal management and inspections apply. As an EU/EEA jurisdiction, the EU pharmacovigilance framework applies to the EU QPPV and Union PSMF, EudraVigilance ICSR reporting, applicable PSURs, RMPs, signal management, quality-system audits and competent-authority inspections. MAHs should also check current national submission channels, contact arrangements and language requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Difference in QPPV Nomination Between EU and KSA; PSMF Maintenance: Concept and Importance in Pharmacovigilance.