Gabon

Pharmacovigilance activities in Gabon are overseen by the Agence Nationale du Médicament et des Autres Produits de Santé (ANMAPS), under the supervision of the Ministry responsible for Health, in accordance with national pharmaceutical legislation and health-vigilance requirements. ANMAPS is responsible for post-marketing monitoring of medicinal products, pharmacovigilance, collection and assessment of adverse-event information, health-risk management, and pharmaceutical market surveillance and control. Current publicly accessible national sources do not establish detailed MAH-specific requirements for a locally resident QPPV, PSMF/PSSF, fixed ICSR reporting timelines, routine PSUR/PBRER periodicity, or universal submission of an RMP. Where the cited public sources do not expressly define 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.