Cabo Verde

Pharmacovigilance in Cabo Verde is coordinated by the Entidade Reguladora Independente da Saúde (ERIS) through the Centro Nacional de Farmacovigilância (CNF) under the national system instituted by Decree-Law No. 17/2017. ERIS's specific Instructions for Marketing Authorisation Holders/Operators require the MAH/operator to establish a pharmacovigilance procedure, designate a technical person responsible for pharmacovigilance, and maintain a system that collects, records and communicates safety and quality information. The holder must submit documentation required by the pharmacovigilance rules, including risk-management/minimisation plans and periodic safety reports, and must immediately notify ERIS of serious suspected ADRs and serious medicine-related problems concerning its products. ERIS's published instruction uses 'immediately' for these serious reports and does not establish a numeric deadline. ERIS expressly requires risk-management and risk-minimisation plans and publishes a Plano de Gestão de Risco among its official pharmacovigilance documents. Where the cited public sources do not expressly define a pharmacovigilance system file, ICSR reporting route and numeric timelines, 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.