Burkina Faso

Pharmacovigilance in Burkina Faso is coordinated by the Agence Nationale de Régulation Pharmaceutique (ANRP) under the national vigilance framework. ANRP's official regulatory repository lists Decree No. 2012-1033 establishing the national health-products vigilance system and Order No. 2013-542 organizing the adverse-effect notification circuit, and provides national vigilance reporting tools. The current public official materials confirm the national vigilance/reporting framework but do not identify a standalone MAH GVP document establishing a local QPPV, EU-style PSMF, fixed MAH ICSR timelines, or universal PSUR/RMP submission schedule. Product- and authorisation-specific obligations depend on the applicable authorisation requirements. 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.