Mozambique

Pharmacovigilance in Mozambique is regulated by the Autoridade Nacional Reguladora de Medicamentos, IP (ANARME). The Manual de Boas Práticas de Farmacovigilância para titulares de AIM requires each MAH to operate a national pharmacovigilance system and designate a resident Responsável de Farmacovigilância (RFV). The RFV must be a pharmacy professional with pharmacovigilance training or experience, be immediately available and have a trained substitute; neither role may be outsourced. The MAH must maintain an Arquivo Mestre ou Manual do Sistema de Farmacovigilância, SOPs, trained personnel and a quality system. Serious suspected adverse reactions are reportable within 24 hours of awareness and non-serious reactions within seven days. The Manual also addresses periodic safety reports, lifecycle Planos de Gestão de Risco, risk-minimisation measures and documented self-inspection, preferably annually and no more than two years apart. Permitted activities may be outsourced, but regulatory responsibility remains with the MAH. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.