Burundi

Medicines regulation in Burundi is overseen by the Autorité Burundaise de Régulation des Médicaments à usage humain et des Aliments (ABREMA). ABREMA's official vigilance and pharmaceutical-advertising legal framework addresses pharmacovigilance, risk management and safety communication, while ABREMA's statutory functions include post-marketing surveillance of adverse effects. The current public official materials do not provide a detailed MAH GVP guideline establishing a local QPPV, EU-style PSMF, fixed MAH ICSR timelines, or a universal PSUR/RMP schedule. Regional or EU templates do not establish those requirements; product-specific confirmation with ABREMA is required. 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.