Angola

Pharmacovigilance in Angola is coordinated by the Regulatory Agency for Medicines and Health Technologies (ARMED) under Presidential Decree No. 253/21 on Pharmacovigilance. The Decree requires pharmaceutical establishments to comply with good pharmacovigilance practices, designate a pharmacovigilance focal point and communicate that designation to ARMED, and maintain a pharmacovigilance service under the responsibility of a pharmacist or pharmacy technician with permanent communication to ARMED. Establishments handling or marketing medicines must immediately report any serious or unexpected adverse effect and must prepare risk-management plans for marketed products, submitting them when requested by the competent authority. The Decree does not establish an EU-style QPPV or PSMF requirement, so those terms are not established as mandatory Angolan requirements. Where the cited public sources do not expressly define ICSR reporting route and timelines, periodic safety reporting, 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.