Ghana Pharmaceutical Licensing

Ghana regulates activities on separate tracks. The Pharmacy Council issues retail and wholesale pharmacy licences and registers retail, wholesale, import wholesale, institutional and manufacturing wholesale pharmacies; the FDA separately licenses manufacturing facilities and storage/distribution facilities for products intended for use or sale in the Ghanaian market. If a business operates a pharmacy, storage facility, manufacturing operation or import activity at the same time, one licence must not be treated as automatic authorisation for the other activities.

The applicant described in the Pharmacy Guidelines is a corporate body that has employed a registered pharmacist, or a medical treatment centre that has employed a pharmacist, and must specify the location. The materials reviewed do not set uniform foreign ownership, minimum capital or company-form requirements applicable to pharmacy, warehousing or manufacturing premises; the proposed structure should be verified with the relevant authorities.

— Retail: Pharmacy Council retail pharmacy pathway.

— Wholesale/warehousing: check the Pharmacy Council and FDA pathways separately.

— Manufacturing, product registration, import/export, controlled substances and individual practice are separate matters.

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Act 851 establishes the FDA’s medicines regulatory framework, including product registration, imports, controlled substances, premises registration and licences/permits. The FDA publicly states that its Manufacturing Facilities Department licenses manufacturing facilities, while its Storage Facilities Department licenses storage and distribution facilities.

Part Four of Act 857 establishes the Pharmacy Council and covers pharmacist registration, company licensing, wholesale of restricted medicines, medicine classification and premises inspections. Pharmacy operations and pharmacists fall under the Council’s remit; products, facility quality and cross-border matters fall under the FDA’s remit.

— Pharmacy Council: pharmacies, superintendent pharmacists, renewals and changes.

— FDA: GMP/GDP, product registration, imports/exports and controlled substances.

— Separate warehousing materials may require local engineering permits.

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Retail pharmacy applications are handled by the Pharmacy Council. Applicants submit the prescribed forms, information and application fee through the website/portal and undergo proposed-site and final inspections. Preliminary approval does not authorise opening for business; operations may begin only after the final requirements are met, the registration fee is paid and a registration certificate stating the superintendent pharmacist is issued.

A pharmacy may supply prescription-only medicines, pharmacy medicines and over-the-counter medicines, but the superintendent pharmacist remains responsible for the custody, dispensing, supply and records of medicines and for removing non-compliant products. Class A medicines may be supplied only on prescription. The name of the pharmacist on duty and the premises registration certificate should be displayed during business hours.

— Submit forms and business/personnel information and undergo inspection.

— Issues identified must be corrected through CAPA and may be subject to reinspection.

— A physical pharmacy licence should not be assumed to cover an online pharmacy, product registration, imports or eligibility to handle controlled drugs.

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The Pharmacy Council requires wholesale activities to be conducted from registered premises holding a valid wholesale licence. Restricted medicines must be supervised by a pharmacist; Class A or Class B medicines may be supplied against orders from authorised persons. Supply is permitted only to authorised persons, transaction records must be kept, and vehicles cannot be used as direct supply points (except for delivery of compliant orders).

The FDA has a separate licensing pathway for storage facilities of wholesalers/distributors: apply to the FDA in writing and submit business registration, proof of fee payment, land documents, a location map, floor plans and any applicable engineering permits. Once the documents are accepted, the facility undergoes a GDP inspection and, where necessary, CAPA.

— Inspections may require a quality system, SOPs, supply agreements, personnel credentials, proof of ownership/lease and a product list.

— Maintain receiving and dispatch zones, temperature control, segregation, recalls, transport and traceability on an ongoing basis.

— Where both wholesale and storage/distribution are actually conducted, confirm the licensing combination with both authorities.

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The FDA’s Manufacturing Facilities Department licenses facilities manufacturing, among other products, allopathic medicines, veterinary medicines, vaccines, biologics, herbal medicines and homeopathic medicines. Application materials include business registration, proof of fee payment, a quality manual/land documents, and information on products, processes, key personnel, premises, water treatment and waste; separate applications are generally required for multiple locations.

A GMP inspection is conducted after the document review is complete. Deficiencies must be addressed through CAPA, with reinspection where necessary; a manufacturing licence or GMP certificate may be issued only after the inspection report and CAPA are satisfactory. Manufacturing licences are renewed annually and may be subject to announced or unannounced follow-up inspections.

— A manufacturing premises licence does not replace product registration, import permits or controlled-substance permits.

— Manufacturing operations must be supervised by a pharmacist or a qualified person approved by the FDA.

— If also operating as a pharmacy wholesaler, check the Pharmacy Council licensing requirements separately.

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All pharmacies must be supervised by a registered pharmacist in good standing with the Pharmacy Council. A proposed superintendent pharmacist must have at least 12 months of post-registration practice experience in Ghana and be employed full time; individual pharmacists must also renew their licences annually, with current requirements including 10 CPD points, a form and a fee.

For manufacturing, section 115 of Act 851 requires supervision by a pharmacist or a qualified person approved by the FDA. The FDA Qualified Person scheme includes academic qualifications, experience/training, employer nomination, FDA assessment and renewal every 3 years, and covers GMP, quality control, deviations, batch records and release; it is not equivalent to individual pharmacist registration.

— To replace a superintendent pharmacist, submit a change form, resignation/termination documents and the new contract.

— The wholesale supply of restricted medicines requires pharmacist supervision.

— Qualified personnel for manufacturing must submit their qualifications to the FDA; those with insufficient experience may be required to undertake training and examinations.

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A proposed pharmacy site must be a permanent, accessible structure with a washroom within or adjacent to the building. A retail pharmacy must have at least 36 square metres and a ceiling height of 3.2 metres, with customer, dispensing, office and consultation areas, and be equipped with a sink, ventilation, lighting, storage and cleanable surfaces.

A wholesale pharmacy must have separate reception, storage, office and accounting areas, with ventilation, shelving/pallets and good wholesale controls in the storage area. An FDA application for a separate warehouse must also include the site master file, drawings, applicable engineering permits and a GDP inspection; manufacturing is assessed against the process, quality system and GMP.

— Retail sites are also assessed against accessibility, population and the 400-metre radius criterion.

— The wholesale guidelines state 48 square metres in the pre-approval section and 36 square metres later, creating an internal inconsistency.

— The materials reviewed do not establish a uniform manufacturing floor-area standard.

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A pharmacy application proceeds through submission of forms/documents/fees, document review, proposed-site inspection, pre-approval, final inspection, payment of the registration fee and issuance of the licence; if issues arise at the final inspection, the applicant must submit CAPA within no more than 25 days.

An FDA manufacturing application undergoes completeness, administrative and technical reviews, followed by a GMP inspection; storage and distribution applications undergo a GDP inspection. CAPA may be required in either process, and the FDA decides whether to issue the licence, defer it or refuse it based on the inspection report and CAPA.

— Pharmacy: prescribed forms, Registrar-General’s Department documents, superintendent pharmacist’s documents and applicable contract.

— Manufacturing: company registration, quality manual/site master file, technical documents and applicable environmental documents.

— Warehousing: application letter, site master file, location/floor plans and applicable engineering permits.

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Applications, registration, renewal, changes, inspections and training involve prescribed fees, but this research has not used amounts that were not verified item by item; confirm against the fee schedule and scope of the application at the time of submission.

Pharmacy Council guidelines list receipt, missing-document, inspection and licensing milestones; these are not commitments to an overall timeline that includes requests for additional documents, CAPA, re-inspections and scheduling.

— Pharmacies: renewal is based on the calendar year; the guidelines require renewal by 31/1 of the following year.

— FDA manufacturing: renew annually; apply at least three months before expiry.

— FDA warehousing: apply for renewal one month before expiry.

— FDA changes: 20 working days for notification, 30 working days for prior approval of minor changes and 60 working days for major changes are published milestones and may be adjusted.

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Pharmacies must renew annually and maintain a superintendent pharmacist, records, sanitation and compliant supply. Persistent lack of a pharmacist, supply of non-compliant medicines, supply from unregistered premises, improper record-keeping or failure to renew may lead to sanctions; the Pharmacy Council may suspend or revoke the licence and stop retail/wholesale operations.

FDA manufacturing facilities may be subject to follow-up inspections, and GMP compliance is key to renewal; storage and distribution operations are also subject to routine inspections or inspections triggered by quality issues or changes. Breaches of GDP, licence conditions or the provision of false information may result in suspension, revocation or cancellation.

— Pharmacy: annual renewal, display of the certificate/pharmacist on duty and record-keeping.

— Wholesale/distribution: GDP, temperature control, segregation, recalls and traceability.

— Manufacturing: GMP, deviations/CAPA, batch records and release controls.

— A written notice is required for closure; closure may not exceed one year, and a final inspection is required before reopening.

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A change in pharmacy ownership/directors does not automatically transfer the licence. The applicant must notify the Council and submit a change form, necessary legal transfer documents, registration documents for the new entity, other Act 857 documents and fees. Changes to the name, superintendent pharmacist, location, business type, layout or scope of activities also have their own change procedures; relocation requires an inspection.

Under an FDA warehousing licence, a change of ownership, relocation and addition of products requiring different storage conditions are major changes; expansion, changes to activities, and administrative changes to the name or address are minor changes requiring prior approval; changes to pharmacists or other qualified personnel are among the changes requiring notification. Manufacturing licence holders must also report changes to facilities and operations.

— Pharmacy location/layout: complete the change process and undergo any applicable inspection in advance.

— Pharmacy manager: do not omit departure/termination documents or the new contract.

— The FDA may reclassify or amend a change based on the submitted information; an internal decision cannot replace a filing.

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Product registration is separate from premises licensing. The FDA allopathic drug registration guidelines require a separate application for each product and submission of information about the manufacturing site and a valid manufacturing licence. An applicant that is not resident in Ghana must appoint a local representative established in Ghana, authorised by the FDA to import and holding a wholesaler's licence; this requirement is not equivalent to a general restriction on foreign ownership.

Only FDA-licensed importers may import; ordinarily, only registered products may be imported, and each consignment requires prior electronic authorisation and inspection at an approved port. Controlled substances also require a quota, a specific import permit, arrival notification and quarterly returns; controlled raw materials must not be resold or transferred.

— Product registration, importer licensing and consignment-specific import authorisation are each required separately.

— For exports, an intention letter and documents such as a packing list, invoice, copy of the registration certificate and certificate of analysis must be submitted to the FDA.

— Unregistered commercial imports may be detained, returned, disposed of or penalised.

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