Benin

Pharmacovigilance in Benin is coordinated by the Beninese Agency for Medicines and Other Health Products (ABMed) through its national vigilance system. ABMed's official vigilance materials describe a national system for detecting, reporting, investigating and assessing adverse events, coordinated by the agency's vigilance service, and confirm that laboratories and international organisations contribute safety reports concerning products marketed in Benin. ABMed also publishes a national vigilance regulatory framework and its 2025 inspection guideline confirms that vigilance systems may be inspected against applicable national good-practice standards. The current public official sources do not support the specific claim that every MAH must appoint a person titled 'PRV' or maintain an EU-style PSMF; those requirements are not established unless a specific ABMed rule is identified. MAHs should comply with ABMed's applicable vigilance, reporting and inspection requirements and any product-specific risk-management conditions. Where the cited public sources do not expressly define local QPPV or responsible-person arrangement, periodic safety reporting, risk-management plan and signal management, 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): How to Prepare and Comply with a Pharmacovigilance Inspection.