France

Pharmacovigilance activities in France are regulated by the Agence nationale de sécurité du médicament et des produits de santé (ANSM) under the French Public Health Code, Bonnes pratiques de pharmacovigilance and applicable EU GVP. MAHs must maintain the EU pharmacovigilance system, including an EU/EEA QPPV and PSMF. In addition, an undertaking or organisation exploiting a medicinal product in France must designate a personne de référence en matière de pharmacovigilance (RPV), who must be a physician or pharmacist, reside and perform the role in France, have pharmacovigilance experience and be linked to the EU QPPV. French requirements additionally cover EudraVigilance reporting, PSUR/PBRER, risk-management and risk-minimisation activities, local literature surveillance, national signal detection, audits and ANSM pharmacovigilance inspections. 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.