Equatorial Guinea

Pharmacovigilance and medicines-safety activities in Equatorial Guinea are overseen by the Ministry of Health and Social Welfare and operate within the national medicines framework established under Law No. 3/2003 on Medicines. The law requires healthcare professionals and citizens to promptly report anomalies and unexpected adverse reactions to the Ministry. Publicly accessible official sources do not establish detailed MAH-specific requirements for a local QPPV or residency, PSMF/PSSF, fixed MAH ICSR timelines, PSUR/PBRER periodicity, universal RMP submission, formal MAH signal management, or PV-specific audits. A 2022 Ministry source described a pharmacovigilance Ministerial Order as a draft pending review/approval. Product-specific obligations should therefore be confirmed directly with the Ministry. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.