Tunisia

Pharmacovigilance in Tunisia involves the National Agency for Medicines and Health Products (ANMPS), the Directorate of Pharmacy and Medicines (DPM) and the National Pharmacovigilance Centre. The 2025 human-medicines registration guide requires the applicant to provide a detailed description or summary of the pharmacovigilance system and a pharmacovigilance plan as part of the dossier. MAHs must maintain local safety-reporting and benefit-risk arrangements and comply with periodic reporting and risk-management requests. A universal EU-style QPPV/PSMF model is not established without a current Tunisian implementing requirement. Where the cited public sources do not expressly define ICSR reporting route and timelines, periodic safety reporting, risk-management plan, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.