Spain

Pharmacovigilance in Spain is regulated by AEMPS under EU legislation, EU GVP and Royal Decree 577/2013. The MAH must maintain an EU/EEA QPPV and PSMF and meet EudraVigilance, PSUR, RMP and inspection obligations. Spain also requires nomination of a national pharmacovigilance contact to support the EU QPPV on Spanish matters; the role is a national requirement rather than merely an optional arrangement. 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.