The Agence Nationale des Médicaments et des Évacuations Sanitaires (ANAMEV) has announced that marketing authorisation (autorisation de mise sur le marché, AMM) became mandatory for all health products on 1 September 2026.
A product is “homologué” (approved) when ANAMEV experts have examined its dossier and the National Commission for the Registration of Pharmaceutical Products (Commission Nationale d’Homologation des Produits Pharmaceutiques, CNHPP) has granted approval. The review covers composition, manufacturing, effects and labelling.
The obligation applies to four categories: medicines, herbal medicinal products, cosmetics and medical devices intended for health or consumer wellbeing. Unapproved products have undergone no official verification and may be underdosed, poorly stored, expired or contain dangerous substances, according to the authority.
Final decisions on granting or refusing AMM rest with ANAMEV’s Director General, acting on the advice of the CNHPP, which comprises independent experts.
The authority stated that eventually all products available on the Comorian market will have been verified by ANAMEV, giving patients assurance that medicines, herbal products and medical devices meet controlled safety and quality criteria.
The authority did not state how many products currently on the market lack authorisation, what transition arrangements apply for existing stock, whether enforcement actions have begun, or penalties for non-compliance.
Source: Agence Nationale des Médicaments et des Évacuations Sanitaires (ANAMEV), “Comprendre l’AMM en 5 questions”, 18 September 2026: https://www.anamev.org/actualite.php?id=33
