Nigeria Pharmaceutical Licensing

The PCN Act covers premises used for pharmaceutical activities including retail, wholesale, manufacturing, storage, import and export, and subjects them to registration and inspection; NAFDAC separately regulates pharmaceutical manufacturing, product registration, and import and export matters. At a minimum, the business plan should be divided into four workstreams: premises, personnel, products and cross-border activities.

For a foreign company operating a chain of retail/community pharmacies, the Act states that the board must include Nigerian pharmacists who collectively hold at least 40% of the shares. This provision does not permit the parties to treat a share transfer closing as automatically transferring a premises licence, nor does it support inventing a uniform capital or company-form threshold.

— Nationwide PCN requirements are handled and inspected by the state/regional office where the proposed site is located.

— No nationwide uniform checklist for state and local planning, fire safety, environmental, tax and business requirements was verified in this research; these must be confirmed for each site.

PCN is responsible for pharmacists and pharmaceutical premises. A Superintendent Pharmacist's personal registration and annual practising licence are separate from registration/retention of the business premises.

NAFDAC's 2024 local drug registration and GMP guidelines, 2025 imported drug guidelines, and 2024 controlled-product import guidelines explain that product requirements, manufacturing quality requirements and controlled cross-border permits are not interchangeable.

— PCN: premises location, structure, inspection, retention renewal and professional supervision.

— NAFDAC: separate approvals for product registration, GMP, controlled-product import/clearance and product advertising.

A new community/retail pharmacy should apply to the PCN state/regional office where the premises are located using Form B, and complete location and pre-registration inspections. The Superintendent Pharmacist must be a fully registered pharmacist holding a valid annual practising licence.

The PCN inspection guidelines set a minimum floor area of 30 square metres for community pharmacies and specify arrangements for dispensing, consultation/pharmaceutical care, waiting and storage areas; the site must not fall within prohibited categories such as motor parks, filling stations, markets or kiosks/containers.

— When the Superintendent Pharmacist is absent, listed prescription medicines in the dispensing area must be locked away.

— Temperature and humidity monitoring, suitable shelving/pallets, purchase and sales records, and refrigeration equipment used only for preparations requiring refrigeration should be provided.

Wholesale, distribution, storage and import premises should follow the PCN premises registration and inspection pathway and be under the direct supervision of a Superintendent Pharmacist. The company's pharmacist-director requirement applies to businesses including manufacturing, import, export, storage, distribution or wholesale.

The minimum floor area specified in the PCN guidelines for ordinary wholesale and distribution/import premises is 70 square metres; large/public/coordinated wholesale centres may be subject to different classification rules, so the business model must be determined first.

— Warehousing, records, appropriate storage facilities and security arrangements are key inspection points.

— NAFDAC product registration and any applicable sample import permit should be confirmed separately for products intended for import.

In addition to general premises and personnel information, a manufacturing application should include the proposed products, organisational structure, personnel responsibilities, building and process flow diagrams, production and quality-control equipment, water-system information, sources of supply, SOPs and cleaning procedures.

The NAFDAC 2024 GMP guidelines remain in effect until 2029 11 and cover pharmaceutical quality systems, personnel, premises and equipment, qualification and validation, documentation, production, materials, quality control, contract activities, complaints/recalls and self-inspection. PCN manufacturing premises registration does not mean NAFDAC GMP requirements have been met.

— Each locally manufactured medicine must be submitted separately through NAPAMS with a product dossier.

— Product registration assessment considers the dossier, GMP status of the manufacturing facility and, where applicable, laboratory analysis; an electronic product registration certificate is issued only after approval.

The premises must be under the direct supervision of a registered Superintendent Pharmacist holding a valid annual practising licence. If the Superintendent Pharmacist is absent for 30 consecutive days, the premises licence expires at the end of that period.

The superintendent pharmacist at a new community pharmacy, wholesale, distribution or import premises must also meet the requirements for full registration, NYSC completion/exemption and applicable mandatory continuing professional development under the PCN 2025 Registration Guidelines. Manufacturing teams must additionally meet NAFDAC GMP requirements for personnel, responsibilities and quality systems.

— An individual annual practising licence is not a premises licence.

— An individual annual practising licence also does not constitute authorisation to import or clear controlled drugs.

The PCN requires a location assessment and pre-registration inspection before registration. The minimum floor area is 30 square metres for an ordinary community pharmacy and 70 square metres for ordinary wholesale and distribution/import premises. Details of the specific buildings, processes, quality control and water systems at manufacturing premises must be submitted according to the business activity.

Controlled substances/poisons must have a register and dedicated secure storage, and may be handled only by a licensed pharmacist. For manufacturing, NAFDAC GMP requires ongoing control of the premises and equipment, documentation, validation, quality control, and systems such as recalls and self-inspection.

— Pharmacy premises must generally comply with PCN rules on distances between pharmacies and prohibited locations.

— Local land, planning, fire safety, environmental and property requirements should be confirmed separately before finalising an address.

The premises process is generally as follows: first apply to the PCN for location approval/inspection, then apply for a pre-registration inspection and premises registration once the premises, personnel and materials are ready. Form B, the superintendent pharmacist’s annual practising licence, company/director details, proof of fee payment and relevant declarations are the common core documents.

The product process is handled through NAFDAC NAPAMS, with a separate application for each product. For imported products, the guidelines also require documents for the local applicant company, overseas manufacturing/free sale and GMP, the PCN superintendent pharmacist’s annual licence, and proof of premises retention.

— For manufacturing premises, also prepare factory, personnel, equipment, production/quality control, water system, supplier, SOP and cleaning documentation.

— NAFDAC product registration, sample import permits, advertising permits and controlled products permits are not automatic outcomes of a PCN premises application.

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Public guidelines direct applicants to the PCN/NAFDAC fee schedules in force at the time, and do not provide a single total price that can safely be applied to all premises, products and services; this draft therefore does not invent fees.

PCN inspection/registration documents list conditional service targets for different stages, such as inspection after the documents and fees are complete, submission by the State/Regional Office and issuance by the registry. NAFDAC local and imported product registration guidelines specify a target of 120 working days from acceptance of a submission to issuance of a registration number, with the clock stopped when a compliance query is issued.

— A successful NAFDAC product registration certificate is valid for five years.

— Controlled-substance import permits expire on 31/12 of the year of issue; the guideline target for complete and satisfactory applications is 5 working days.

PCN premises should undertake renewal/retention from 1/1 each year. The Act requires applications in January; if fees are not paid by 31/3, PCN may close the premises and remove them from the register, and operating after the deadline may also constitute an offence.

PCN routine inspections are conducted on a risk-rating basis, and manufacturing premises are additionally subject to re-granting licence inspections. Manufacturing companies should continuously operate the quality systems, documentation, validation, quality control, complaint/recall and self-inspection arrangements required by NAFDAC GMP.

— Maintain the superintendent pharmacist’s annual practising licence and direct supervision on an ongoing basis.

— Keep records of purchases and sales, controlled substances/poisons and, where applicable, product quality and distribution.

For any change to the superintendent pharmacist, premises structure, location, scope of business or other matter that may affect a licence, apply to the PCN Registrar for approval. Changes to company details, pharmacist-director details, ownership, premises business type or company name must be notified to the PCN within 60 days at the latest.

The PCN 2025 Registration Guidelines require changes to the superintendent pharmacist, premises name, structure, address, scope of business or the addition of a manufacturing production line, among other changes, to be handled using Form B, accompanied by an explanation and evidence of the change.

— Before a share/control transaction, director change or change in the qualifications of a pharmacist-director, assess the impact on PCN changes.

— If product registration, controlled products registration/import permits or advertising permits are affected by the licence holder, manufacturing site, label, formulation or ingredients, they must still be assessed separately under NAFDAC rules.

Local and imported medicines must each be registered by product under NAFDAC rules. Imported products require a separate application through NAPAMS. Product registration does not automatically grant an advertising permit; advertising requires a separate application to NAFDAC.

In addition to registration, products containing narcotic, controlled/psychotropic substances, precursors or domestically controlled drugs require an Import Permit for import and, where applicable, a Permit to Clear. Only holders of the relevant controlled products registration certificate may apply; importation through a third party is prohibited.

— Controlled products applications are submitted through the Federal Single Window for Trade Portal and must include, among other documents, an application signed by the superintendent pharmacist, an annual practising licence, premises retention, product registration and records of previous disposal/distribution.

— Current consignment-by-consignment commercial export permit/clearance guidelines for ordinary non-controlled medicines were not obtained in this review; the controlled products import process or product registration must not be treated as establishing a permit requirement for ordinary drug exports.