Guinea-Bissau

Pharmacovigilance in Guinea-Bissau is developing within the national medicines-regulatory structure under the Ministry of Public Health (MINSAP), with the Autoridade Reguladora de Farmácia, Laboratório, Medicamentos e outros Produtos de Saúde (ARFAME) having a pharmacovigilance function. Publicly available health-system assessments indicate that pharmacovigilance strategy documents, guidelines and SOPs had been developed and technically validated but were not formally adopted or implemented at the time of the cited assessment. Based on the currently published requirements, no binding national requirement could be confirmed for an MAH-specific local QPPV or local pharmacovigilance responsible person, a PSMF, or defined routine PSUR/PBRER and RMP submission cycles. These requirements are therefore not established as mandatory for Guinea-Bissau unless supported by a current product-specific or authority-issued requirement. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.