Republic of the Congo

Pharmacovigilance in the Republic of the Congo is overseen by the Ministry of Health and Population through the national medicines and pharmacy regulatory structure, which includes a dedicated pharmacovigilance function. As a CEMAC Member State, the Republic of the Congo is also subject to the regional pharmacovigilance framework established under Regulation No. 03/13-UEAC-OCEAC-CM-SE-2. Under this framework, marketing authorisation Holders are required to maintain and document an appropriate pharmacovigilance system and have a qualified person responsible for pharmacovigilance; no specific national residency requirement for this person was identified. Serious domestic adverse reactions and serious unexpected adverse reactions occurring outside the country that become known to the MAH are subject to 15-day reporting. Periodic pharmacovigilance safety reporting is provided for under the CEMAC framework, although no separate publicly available Congo-specific submission frequency was identified. National pharmaceutical inspection structures are established to monitor regulatory compliance. No standalone Congo-specific PSMF requirement or universal national RMP submission requirement was identified in current official sources. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.