Senegal

Pharmacovigilance in Senegal is regulated by the Agence sénégalaise de Réglementation pharmaceutique (ARP). Under the national vigilance framework established by Decree No. 2023-2423, every producer or marketing authorisation Holder (MAH) must collect and evaluate serious and non-serious adverse reactions and other required safety information, maintain a safety-data management and notification system, and transmit collected safety information to the competent pharmaceutical-regulation structure within 24 hours. The decree also provides for a person responsible for vigilance (PRV), whose duties follow the good-vigilance practices established by ARP, and requires periodic safety reports in a format, content and frequency determined by the Director General of ARP. Companies should therefore maintain a documented local pharmacovigilance system, keep product safety information current, implement risk-minimisation measures where required, and remain inspection-ready. ARP publishes its French-language Guide de bonnes pratiques de pharmacovigilance and provides an official public adverse-event notification page. Product-specific PSUR schedules, RMP commitments and any additional local conditions should be confirmed with ARP rather than inferred from EU rules. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.