Comoros

Pharmacovigilance in the Union of the Comoros is overseen by the Agence Nationale des Médicaments et des Évacuations Sanitaires (ANAMEV), which acts as the national pharmaceutical regulatory authority and includes a dedicated Pharmacovigilance Department. The national Public Health Code recognizes a national pharmacovigilance system and provides for regulatory action where pharmacovigilance identifies a safety concern. Pharmacovigilance documentation is also included among ANAMEV’s documentation requirements for marketing authorisation applications. Persons involved in medical promotion and scientific information are required to communicate newly identified adverse effects to the national pharmacovigilance structure and the manufacturer without delay. However, no publicly available official requirements establishing a specific general MAH ICSR reporting timeline, a locally resident QPPV/LPPV, a standalone PSMF/PSSF, a routine PSUR/PBRER submission schedule, or a universal MAH RMP submission requirement were identified in current national sources. ANAMEV also maintains an inspection function for pharmaceutical-sector compliance. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.