Ireland

Pharmacovigilance in Ireland is regulated by the Health Products Regulatory Authority (HPRA) within the EU/EEA framework and EU GVP. MAHs must have an EU/EEA QPPV and maintain an EU PSMF; there is no separate general Irish-residency requirement for the QPPV. ICSRs are submitted through EudraVigilance, with serious valid ICSRs reported within 15 days and non-serious valid ICSRs within 90 days. PSUR/PBRERs follow the EU EURD and PSUR repository process, while EU RMP, signal-management and inspection requirements apply. HPRA also manages national interaction for additional risk-minimisation materials where applicable. 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.