Italy

Pharmacovigilance in Italy is regulated by the Agenzia Italiana del Farmaco (AIFA) within the EU/EEA framework and EU GVP. An EU/EEA QPPV and EU PSMF are required; the QPPV is not required to reside specifically in Italy. AIFA may require or record a national pharmacovigilance contact in situations foreseen by the Italian/EU framework, but this is not a universal second Italian QPPV. ICSRs are transmitted through EudraVigilance within the EU 15-day serious and 90-day non-serious timelines. PSUR/PBRER, RMP and signal-management requirements follow the applicable EU framework and AIFA national implementation, together with pharmacovigilance-inspection requirements. 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.