Slovakia

Pharmacovigilance in Slovakia is regulated by the State Institute for Drug Control (ŠÚKL) under EU legislation and EU GVP. The MAH must maintain an EU/EEA QPPV and PSMF and fulfil EudraVigilance, PSUR and RMP obligations. Slovakia additionally requires a national pharmacovigilance contact reporting to the EU QPPV; the person must have relevant PV knowledge, know applicable requirements, communicate in Slovak or Czech and be notified to ŠÚKL. The premises may be outside Slovakia, but the PV activities must cover Slovakia. 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.