Côte d’Ivoire Pharmaceutical Licensing

This record concerns only the retail, wholesale, and manufacture of human medicines. AIRP administers institutional authorisations, AMMs, imports and exports, and inspections separately; business registration cannot replace pharmaceutical regulatory authorisation.

The materials verified describe the national system; no basis for separate state/provincial licensing was found. Nationality and company-form requirements listed on the retail webpage should not be extrapolated as general conclusions for manufacturing or complex foreign-investment transactions.

— First define whether the activity is retail, wholesale, or manufacturing.

— Maintain separate files for the institution, pharmacist, products, and cross-border permits.

AIRP is responsible for medicine AMMs, commercialisation, the establishment/operation of pharmaceutical institutions, imports and exports, inspections, quality, and pharmacovigilance. ONPCI is a key point of contact for pharmacist registration and professional organisation.

In 2024, AIRP stated that it had fully implemented UEMOA regional rules on human medicine registration, good practices for medicine distribution/importation, and GMP, among others.

— Institutional licensing and inspections: AIRP.

— Pharmacist registration and statutory opinion on retail licences: ONPCI.

A pharmacy must obtain an establishment/relocation permit before opening. The permit is tied to a fixed location and cannot be transferred separately from the business assets; an operating permit must also be applied for after opening.

The published checklist for an operating permit includes the establishment permit, ONPCI annual registration, commercial/tax documents, articles of association where applicable, and an AIRP pre-opening compliance inspection report. A pharmacy may not be located within a healthcare facility or carry out medical procedures.

— Obtain the establishment/relocation permit first, then arrange the compliance inspection.

— Handle opening, the operating permit, and product/import permits separately.

Wholesale distribution of medicines is an activity of pharmaceutical institutions; private wholesale distributors are, in principle, permitted to supply pharmacies only. Manufacturing, import, export, and wholesale activities cannot be conducted by an ordinary trading entity outside this framework.

The current service page lists the project, company documents, premises/layout, personnel, management, and responsible pharmacist materials. An official document hosted from 2010 also lists proof of premises rights, equipment, and staff responsibilities, but its current validity must be confirmed.

— Verify the intended customers and distribution channels.

— Prepare auditable records concerning the responsible pharmacist, storage, equipment, and personnel.

A manufacturing facility must first apply to AIRP for in-principle approval, submitting information on the promoters, products, site selection, technical matters, personnel, storage, funding, GMP commitment, and business plan. In-principle approval does not authorise manufacturing or commercialisation.

The next steps are drawing approval and an application for authorisation, requiring information on flows, utilities/waste, company and sectoral permits, the site master file, management, and the responsible pharmacist’s dossier.

— Proceed to construction and apply for authorisation only after in-principle approval.

— Set separate milestones for the manufacturing institution, product AMMs, commercialisation, and imports.

If the holder of a retail pharmacy licence is absent, another pharmacist must lawfully provide cover. Technical management of manufacturing and wholesale operations must be undertaken by a pharmacist registered with ONPCI, and each institution must have a responsible pharmacist.

The responsible pharmacist supervises pharmaceutical operations, manufacturing/packaging controls, and batch release. The published checklist requires the pharmacist’s identification, qualifications, résumé, employment contract, and annual registration certificate.

— Keep the responsible pharmacist’s ONPCI registration valid.

— Document arrangements for appointment, deputising, and replacement during suspension of practice.

Retail locations are subject to national planning; establishment/relocation permits specify a fixed operating location, and pharmacies may not be located within healthcare facilities. Wholesale operations must have premises, equipment, and personnel that ensure proper storage and distribution.

Manufacturing drawings must show the flows of people, materials, packaging materials, and finished products; air and utilities; and wastewater/waste handling. Ordinary warehouse drawings cannot substitute for these.

— Obtain AIRP’s compliance inspection before opening a retail pharmacy.

— Check AIRP’s inspection checklist for wholesale and manufacturing designs before submitting them.

Retail operations proceed through establishment/relocation, a pre-opening compliance inspection and an operating licence; wholesale applications are based on the organisation, premises, personnel and responsible pharmacist documentation; manufacturing proceeds in sequence through principle approval, drawing confirmation and an approval application.

Electronic licensing documents should use the version in force on the filing date. Historical wholesale documents may be used to identify gaps, but the receiving authority, forms and number of copies should be confirmed with AIRP.

— Prepare a five-column checklist covering organisation, personnel, premises, products and cross-border matters.

— Confirm the current forms, fees and paper/electronic submission route before filing.

The private pharmacy operating service page lists renewal every 10 years, a renewal inspection, 250,000 FCFA and a “155-day” field; the wholesale service page lists renewal every 5 years, a renewal inspection, 2,500,000 FCFA and a “225-day” field.

The manufacturing service page does not show a standard fee, processing period, licence term or renewal requirement. The 3-month validity period and 72-hour processing target for imports apply only to a single import authorisation.

— Confirm fees and timelines separately with AIRP for each service.

— Allow a buffer for requests for additional information, inspections and product reviews.

If the responsible pharmacist of an industrial or wholesale organisation becomes aware of a manufacturing, import or distribution incident that may endanger public health, they must stop sales, recall the products and report the incident to the administrative authority; manufacturing and wholesale organisations must establish traceability systems.

AIRP is responsible for inspections, quality control, pharmacovigilance and market surveillance. It confirms the applicability of UEMOA GDP/GMP; maintenance systems should cover personnel, premises, records, complaints, recalls and product flows.

— Maintain annual registration and substitute records for the responsible pharmacist.

— Retain traceability, quality incident and recall documentation for inspection.

Relocation, acquisition or sale of a pharmaceutical organisation requires authorisation from the competent authority; a share transaction, change of directors, lease or asset transaction does not automatically transfer operating authorisation.

An agreement on ownership of a retail pharmacy must be made in writing and submitted to the ONPCI regional council and the health authority; the establishment licence is revoked when a pharmacy closes permanently. AIRP should confirm and update the change procedure set out in the old wholesale documents.

— In transaction due diligence, verify the organisation, premises, responsible pharmacist, products and import authorisations separately.

— Obtain guidance from AIRP before a proposed relocation, acquisition, sale or change of responsible pharmacist.

AIRP treats product AMM/marketing, establishment authorisation and imports/exports as separate matters. Approval of an operating organisation does not mean that each product has an AMM or that products may be imported or exported without restriction.

AIRP authorisation must be obtained before importation; the organisation must be accredited and the product must generally hold an AMM or temporary use authorisation. Unregistered products or products nearing expiry require special authorisation; narcotic drugs, psychotropic substances and precursors follow a separate official import authorisation process, and controlled products without an AMM also require special import authorisation.

— Keep AMM, marketing and quality documentation for each product.

— For each consignment, verify the organisation’s eligibility, invoice, batch number/expiry date and import authorisation.