Guinea

Pharmacovigilance in Guinea is coordinated by the Direction Nationale de la Pharmacie et du Médicament (DNPM) under the Ministry of Health and Public Hygiene, in accordance with the national pharmacovigilance guidelines. Pharmaceutical companies holding a marketing authorisation are required to establish a functional pharmacovigilance unit and an internal pharmacovigilance system with a qualified person responsible for pharmacovigilance. Serious and unexpected adverse reactions must be reported without delay; the national reporting table specifies 24–48 hours for serious cases reported by the pharmaceutical industry and 24 hours in the event of death. Companies must submit pharmacovigilance periodic safety reports every three months for new products and annually for other products, and provide a Risk Management Plan when requested by the DNPM. No requirement for an EU-style Pharmacovigilance System Master File (PSMF) was identified in current national guideline. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.