Slovenia

Pharmacovigilance in Slovenia is regulated by JAZMP under EU legislation and EU GVP. The MAH must maintain an EU/EEA QPPV and PSMF and meet EudraVigilance, PSUR, RMP and inspection obligations. A Slovenian national contact may be appointed and notified, especially where the MAH is not established in Slovenia, but it is not generally mandatory; JAZMP may require one in individual cases. 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.