Chad

Pharmacovigilance in Chad is overseen by the Ministry of Public Health and Prevention within the applicable national and CEMAC regulatory framework, notably CEMAC Regulation No. 03/13-UEAC-OCEAC-CM-SE-2 on pharmacovigilance. Marketing authorisation Holders (MAHs) are required to maintain an appropriate pharmacovigilance system, keep its documentation up to date, and designate a qualified person responsible for pharmacovigilance. Serious domestic adverse reactions, as well as serious and unexpected adverse reactions occurring outside the country that become known to the MAH, are subject to reporting to the national regulatory authority within 15 days. MAHs are also required to provide periodic pharmacovigilance safety reports, although no publicly available Chad-specific universal submission frequency was identified. The framework provides for pharmacovigilance inspections by the national regulatory authority and for pharmacovigilance planning in connection with product registration. A documented description of the pharmacovigilance system is required; however, no standalone Chad-specific PSMF requirement or universal RMP submission requirement was identified in the current public official sources. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.