Rwanda Pharmaceutical Licensing

In Rwanda, human-medicine businesses are regulated nationally by Rwanda FDA. Manufacturing, wholesale and retail are separate premises/business activities and may not be carried on without prior authorisation. Product marketing authorisation, individual practising licences and import/export documents are not automatically obtained with a premises licence. RDB/equivalent registration is one of the application documents, but the verified texts do not provide a generally applicable conclusion on foreign ownership percentages, minimum capital or direct operation by foreign entities.

— This draft focuses on human medicines; although veterinary medicines, devices and other products fall within the broader scope of the guide, human-medicine requirements should not be applied to them interchangeably.

— Area requirements differ between Kigali City, secondary cities and other areas; no separate provincial human-medicine business licensing system was identified.

The Drugs Department of Rwanda FDA covers human-medicine marketing authorisation, premises licensing and inspection, import/export, and post-market oversight. The Product Registration Division assesses quality, safety and efficacy before granting marketing authorisation; the inspection and licensing division inspects premises and GxP/QMS compliance and may grant, renew, suspend or revoke licences.

— Pharmaceutical Inspection and Licensing Division: premises inspections and licensing.

— Drugs Import and Export Control Division: cross-border applications, port inspections and disposition of non-compliant goods.

An application for a human medicines retail pharmacy must include an application letter, premises licensing form, RDB or equivalent registration, premises documents, proof of fee payment, and the qualifications, practising documents, CV and contract of the person in charge. The person in charge must hold a bachelor's degree in pharmacy and be registered with the National Pharmacy Council; this personal professional qualification is separate from the business premises licence. A retail premises licence also does not mean that a product has marketing authorisation.

A retail pharmacy is listed as one of the entities eligible to apply for import authorisation only in the limited circumstance where a prescription-only medicine is unavailable on the local market; separate procedures for the specific cross-border transaction are still required.

— Minimum area: 40 square metres in Kigali City/secondary cities; 30 square metres in other areas; minimum ceiling height 2.5 metres.

— The dispensing area must be separated from the public, lockable, and have an easily cleanable work surface and handwashing facilities.

A human medicines wholesale pharmacy must submit RDB or equivalent registration, premises documents, proof of payment, and the qualifications, practising licence, supply-chain experience, CV and contract of the authorised person in charge. The authorised person in charge must hold a bachelor's degree in pharmacy and be registered with the National Pharmacy Council. Manufacturers, distributors and wholesalers must also maintain systems, facilities and records compliant with GDP/GSP.

The Guidelines distinguish between a distributor and a wholesaler: the former may establish nationwide distribution points, but each point must meet the relevant wholesale requirements and may distribute only to wholesale pharmacies.

— The total area for a human medicines/medical devices wholesaler must be at least 90 square metres: 30 square metres for the sales/records area and 60 square metres for the storage area, with a ceiling height of 2.5 metres.

— Stored goods must be kept off the floor, with temperature and humidity controlled; recalled, expired and rejected goods must be segregated.

Before commencing operations, a manufacturing facility should obtain a premises registration certificate and premises licence from Rwanda FDA, and submit the premises licensing form, GMP/QMS audit application, registration/premises/building-plan documents, environmental impact assessment where applicable, product list, and information about authorised personnel and production, QA and QC staff. The facility must comply with applicable GMP/QMS requirements.

The verified sources do not specify universally applicable minimum floor area, capital or a fixed approval timeframe for human medicines manufacturing facilities; assessment should be made case by case according to the products, dosage forms, processes, equipment and audit scope. A premises licence does not mean that each product has marketing authorisation.

— Key functions include production, the quality unit, quality assurance, quality control and authorised personnel.

— The quality system should cover validation, training, supplier management and batch records.

The authorised person in charge of a human medicines retail pharmacy, wholesale pharmacy, distribution operation or hospital pharmacy must hold a bachelor's degree in pharmacy and be registered with the National Pharmacy Council. At application, verify the notarised qualification/equivalency documents, valid practising licence, CV, identity documents and contract with the operator.

A manufacturing facility should have a written organisational structure, defined job responsibilities and sufficient key personnel. An individual's practising licence and the business premises licence are independent of each other; applicable practising documents must still be submitted when the person in charge changes or the licence is renewed.

— Retail/wholesale: pharmacist qualification, registration, practising licence and contract.

— Manufacturing: qualifications, responsibilities and training records for authorised personnel and production, QA, QC and other staff.

Distribution, wholesale and retail premises should be protected from external contamination and suitable for storage, with cleanable walls and floors, lighting, ventilation, and appropriate temperature and humidity controls; in principle, they should be dedicated to medical products and not connected to other businesses. Access to storage areas must be restricted to authorised personnel; materials/products must be segregated, and recalled, expired and rejected goods isolated.

Human medicines retail and wholesale premises have explicit area requirements; manufacturing facilities are assessed according to GMP/QMS, processes, building plans and inspections, and cannot use retail or wholesale area requirements as a substitute.

— Retail: 40 square metres in Kigali City/secondary cities; 30 square metres in other areas; ceiling height 2.5 metres.

— Wholesale: 90 square metres, comprising a 30-square-metre sales/records area and a 60-square-metre storage area; ceiling height 2.5 metres.

— Controlled substances: fixed, separate, locked storage; temperature monitoring is required for the cold chain.

Applications may be submitted to Rwanda FDA headquarters, the official email address of the Director General, or the integrated information system. Payment does not mean that a licence will be issued; incomplete applications for new premises will not be processed, and Rwanda FDA will decide whether to issue a licence or require corrective action after inspecting the premises.

Common documents include an application letter, premises licensing form, registration, premises documents, fee payment, and the qualifications/contract and identity documents of the person in charge. Manufacturing applications additionally require a GMP/QMS audit application, building plans, environmental impact assessment where applicable, product list and key personnel information. The Regulations state that complete applications are processed within twenty working days, but this is not a promise of approval.

— First determine the business type, product scope and person in charge.

— Submit the documents according to the checklist and undergo inspection; complete corrective actions if any non-compliance is identified.

The verified sources require payment of prescribed fees but do not provide generally applicable fee amounts for retail, wholesale and manufacturing licences. Confirm the applicable service category and Rwanda FDA's instructions at the time of application. A premises business authorisation is valid for twelve months from issuance and may be renewed; renewal should be applied for one month before expiry.

The regulatory processing period for a complete application is twenty working days; an incomplete application will be closed if requirements remain unmet after ninety days. The timeframe for premises licensing must not be applied to product registration, cross-border transactions or controlled substances authorisations.

— Premises business licence: twelve months, renewable.

— Fees: proof of payment is required; no estimate is made in this document.

Manufacturers must comply with GMP; manufacturers, distributors and wholesalers must comply with GDP; and retail dispensers must comply with Good Dispensing Practice. Records of procurement, sales, distribution, imports (where applicable) and personnel must be kept, and the premises licence and practising licence of the person in charge must be displayed.

Rwanda FDA may conduct routine, enforcement, follow-up and special inspections; renewal, a new product line, or a significant change to processes, personnel, premises or equipment may trigger an inspection. Controlled substances must be stored separately under lock, and quarterly distribution reports must be submitted.

— Maintain the quality system, training, temperature and humidity controls, storage/transport conditions and traceability records on an ongoing basis.

— Controlled substances require separate storage and quarterly reporting.

A business authorisation is issued to the applicant and may not be transferred to another applicant or another premises without Rwanda FDA's prior written approval. Significant changes include relocation/additional storage, a change of person in charge, a new production line, expansion, changes to key manufacturing equipment or changes to business activities; the Guidelines require written approval before implementation.

A change of ownership requires an application, the current licence, a notarised sale agreement between the former and new rights holders, RDB or equivalent registration and identity documents for the person in charge. Therefore, a share or asset transaction does not automatically transfer the licence. The Regulations require notification of changes to authorisation information within five working days, while the Guidelines also state that a transferee should apply within thirty days; the relationship between these requirements is not explained.

— Relocation/additional storage: premises licence, registration, payment and documents for the new premises.

— Change of person in charge: the new appointee's qualifications/practising documents, CV and contract, and the former appointee's resignation documents.

— Change of ownership: transaction documents do not replace an application to Rwanda FDA for the change.

Product marketing authorisation is distinct from a premises licence. Before granting Marketing Authorization, Rwanda FDA evaluates the quality, safety and efficacy of the product dossier; import verification documents also require the product registration number. Each import consignment must have an Import Authorization/Visa, and imports and exports also require a permit/verification certificate; goods are inspected at the port of entry. Documents usually required include an invoice, packing list, registration number, batch quality-control documents, certificate of origin and pharmaceutical GMP documents.

Narcotic drugs, psychotropic substances and precursors require specific authorisation in addition to general import/export authorisation. Manufacturers importing controlled raw materials must demonstrate that they are for manufacturing use, and authorised importers/exporters must submit quarterly reports. A general business licence does not cover individual cross-border transactions or controlled-substance procedures.

— Products: marketing authorisation, registration number and post-registration changes.

— Cross-border trade: a Visa for each consignment, permits/verification documents and inspection at the port of entry.

— Controlled substances: specific authorisation, locked storage and quarterly reporting.