Hungary

Pharmacovigilance activities in Hungary are regulated by the National Center for Public Health and Pharmacy (NNGYK; formerly OGYÉI) under EU legislation and EU GVP. The MAH must appoint an EU/EEA QPPV, maintain an EU/EEA PSMF and meet EU ICSR, PSUR and RMP obligations. A local pharmacovigilance contact residing in Hungary is mandatory when the EU QPPV does not reside in Hungary; the appointment and contact details must be notified to the authority. The local contact is not required to be available 24/7 under the national decree, although the MAH must ensure continuous system compliance and inspection readiness. 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.