Greece

Pharmacovigilance activities in Greece are regulated by the National Organization for Medicines (EOF) and are conducted within the European Union pharmacovigilance framework and EU Good Pharmacovigilance Practices (GVP). Marketing authorisation Holders (MAHs) must maintain a pharmacovigilance system, appoint an EU/EEA Qualified Person Responsible for Pharmacovigilance (QPPV), and maintain a Pharmacovigilance System Master File (PSMF). In addition, EOF requires a local pharmacovigilance responsible person in Greece and a deputy/alternate contact, with relevant QPPV/local-contact changes notified to EOF. The PSMF is maintained under EU requirements and is not routinely submitted to EOF unless requested. Individual case safety reporting through EudraVigilance, PSUR/PBRER and Risk Management Plan (RMP) obligations, and pharmacovigilance inspections follow the applicable EU/EEA 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.