Pharmacovigilance Requirements Brief Overview

Côte d’Ivoire

Pharmacovigilance activities in Côte d’Ivoire are overseen by the Autorité Ivoirienne de Régulation Pharmaceutique (AIRP). AIRP describes the national pharmacovigilance function as collecting and evaluating safety information on health products, with adverse-event reporting channels for healthcare professionals and other stakeholders. The current publicly accessible national sources do not establish detailed universal MAH requirements for a locally resident QPPV, a PSMF, fixed MAH ICSR timelines, routine PSUR/PBRER periodicity, universal RMP submission, or a detailed MAH-specific pharmacovigilance inspection framework. Product-specific post-marketing safety obligations should therefore be confirmed with AIRP. Where the cited public sources do not expressly define 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): Effective Signal Management in Pharmacovigilance.

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