Côte d'Ivoire

The primary regulatory authority for health products in Côte d'Ivoire is the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML), operating under the Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle. The principal legal framework is governed by Law No. 2015-533 of July 20, 2015, relating to public health, complemented by various ministerial decrees and orders regulating the importation, registration, distribution, and post-market surveillance of pharmaceuticals, medical devices, in-vitro diagnostics, and related health products. All health products intended for the Ivorian market must undergo a formal marketing authorization (Autorisation de Mise sur le Marché, AMM) process administered by the DPML, which involves technical evaluation by an advisory commission before a registration certificate is issued.

Applicants are required to appoint a locally registered representative or importer, who assumes legal responsibility for the product on the national market. Dossiers are generally expected to follow the Common Technical Document (CTD) format, though alignment with ECOWAS regional harmonization guidelines is increasingly encouraged as Côte d'Ivoire participates in the West African Health Organisation (WAHO) regulatory harmonization initiative. Supporting documentation typically includes proof of marketing authorization in the country of manufacture, good manufacturing practice (GMP) certificates, product quality and safety data, labeling in French, and evidence of local pharmacovigilance arrangements. Recent reforms have focused on strengthening post-market surveillance, digitizing parts of the submission process, and advancing regional regulatory convergence under the ECOWAS framework to reduce duplication and shorten review timelines.

Public procurement of health products in Côte d'Ivoire is centrally coordinated through the Centrale d'Achat des Médicaments Essentiels, Vaccins et Consommables Médicaux (CAMEG-CI), which serves as the primary government entity responsible for the purchase, storage, and distribution of essential medicines, vaccines, diagnostics, and medical consumables to public health facilities nationwide. CAMEG-CI operates under the oversight of the Ministry of Health and procures products through national competitive tenders governed by the general public procurement framework overseen by the Autorité Nationale de Régulation des Marchés Publics (ANRMP). Procurement procedures follow Law No. 2019-1080 of December 18, 2019, on public procurement, requiring open competitive bidding for contracts above defined thresholds, with price, quality, and regulatory compliance as key evaluation criteria. There is no formal federal-state procurement split, as Côte d'Ivoire operates a centralized system, although decentralized health districts may manage smaller procurement processes for locally sourced consumables.

The private sector plays a substantial role in health product distribution, with products reaching end users through a network of licensed pharmaceutical wholesalers and retail pharmacies regulated by the Ordre des Pharmaciens de Côte d'Ivoire. Donor-funded procurement channels are significant, particularly for HIV/AIDS, malaria, tuberculosis, and immunization programs, with major partners including the Global Fund, USAID via the GHSC-PSM mechanism, Gavi the Vaccine Alliance, UNICEF Supply Division, and the World Bank. These channels often follow international procurement standards and may source products independently of CAMEG-CI, though coordination with national authorities is expected. Côte d'Ivoire does not yet enforce strong formal local manufacturing preference policies, though the government has expressed strategic interest in developing regional pharmaceutical production capacity in alignment with the Africa Union's Pharmaceutical Manufacturing Plan for Africa, and preference for products registered and compliant with national standards is consistently applied across all procurement channels.