Croatia

Pharmacovigilance activities in Croatia are regulated by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) under EU pharmacovigilance legislation, EU GVP and the Croatian Medicinal Products Act. The MAH must have an EU/EEA QPPV and maintain an EU/EEA PSMF. Croatia additionally requires a local qualified person for pharmacovigilance who resides in Croatia and is approved by HALMED, together with an approved deputy/back-up arrangement. EU requirements for EudraVigilance reporting, PSURs, RMPs, signal management and inspections also 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.