Uganda Pharmaceutical Licensing

This record focuses on retail pharmacies, wholesale pharmacies and pharmaceutical manufacturing of human or veterinary medicines in Uganda. The NDA defines retail as supplying medicines directly to patients, their agents or caregivers for use and not for resale; wholesale is supply to another licensed/authorised business for resale, or supply to a healthcare facility for treatment use. The two are not interchangeable.

Premises operations, individual pharmacist registration, product registration/marketing authorisation, import or export licences and per-shipment verification certificates are separate layers of requirements. Company incorporation, tax, land/municipal and labour compliance may also be required, but the NDA materials reviewed do not provide uniform capital requirements, foreign ownership limits, company forms, factory floor areas or approval times for all applicants; these must not be invented in this guide.

— Where human and veterinary medicines are to be handled at the same premises, the NDA requires each section to meet the respective minimum personnel and premises requirements, but a single certificate of suitability and licence may be applied for, provided the sections are segregated.

— Confirm the applicable regime first for medical devices, traditional/herbal products, clinical trial products and items classified as non-medicinal; this record does not automatically apply to them.

The NDA operates under the National Drug Policy and Authority Act and its subsidiary regulations on licensing, certificates of suitability of premises and related matters. Its 2022/23 annual report expressly states that the Inspectorate and Enforcement Department is responsible for licensing manufacturers, distributors and medicine suppliers, controlling imports and exports, licensing local manufacturers, pharmacies and drug shops, and conducting GMP inspections of foreign manufacturers.

This case concerns the national NDA regime; it is not an example of a federal country where states/provinces issue licences independently. The regional office handling an actual application, inspection arrangements and electronic account procedures should nevertheless be confirmed against current NDA notices and NDAMIS receipts.

— NDA: premises business licensing, GMP, product registration, cross-border verification and enforcement.

— Individual pharmacists: the person responsible for manufacturing must hold valid registration with the Pharmacy Council of Uganda; individual registration is not an NDA business licence.

Under the 2014 licensing regulations, a retail pharmacy application is made to the NDA using Form 17, with a partnership deed or company constitutional documents, as applicable, a certificate of suitability of premises, and evidence that the person in charge of the pharmacy is a partner or director. Under current guidelines, applicants submit applications for both a certificate of suitability and a business licence through NDAMIS, together with proof of payment, the supervising pharmacist's registration and annual membership of the Pharmaceutical Society of Uganda, an undertaking letter and auxiliary staff details.

Class A and B medicines must be supplied under the supervision of the pharmacist whose registration evidence was submitted; the pharmacy may not supply these medicines when the pharmacist is absent. Class A or Group 1 Class B medicines also require a valid prescription. Retail pharmacies should retain prescription/patient, source of supply, batch, expiry date and quantity records for at least five years and make them available for inspection.

— For a new location, first apply for location approval; after approval, apply for the certificate of suitability of premises and business licence within the applicable period.

— Company application documents listed include Form 20, a board resolution appointing directors and evidence that one director is a pharmacist; for a partnership, assess its partnership documents. This does not establish that all applicants must use a company form.

A wholesale pharmacy application uses Form 18 and must include the entity's partnership/company documents, a certificate of suitability of premises and a certified copy of the responsible pharmacist's registration. After a complete application and payment, the NDA inspects the proposed premises; wholesale applicants must also meet GDP requirements. A certificate of suitability of premises is not a business licence; the business licence is issued only after NDA approval.

When importing or wholesaling Class A and B medicines, a licensed wholesaler must operate under the supervision of the pharmacist named in the application; sales are not permitted when the pharmacist is absent. Wholesalers should retain supplier, quantity, batch, expiry date, import date and verification certificate details, as well as customer, quantity sold, batch, expiry date and stock-on-hand records for each consignment; records of expired or rejected medicines must be retained for at least five years.

— Include storage and transport temperatures, segregation, non-conforming products, batch traceability and customer authorisation checks in GDP procedures.

— Where human and veterinary medicines are handled at the same time, establish segregated sections and meet the respective minimum personnel and premises requirements.

A manufacturing application uses Form 19 and should include the registration evidence of the pharmacist in charge of production, a list of the medicines to be manufactured and their registration evidence, qualifications of key personnel, evidence of compliance with the GMP guidelines adopted by the NDA, and the prescribed fee. Before manufacturing begins, a manufacturer—or a foreign factory producing medicines for import into Uganda—must apply to the NDA for a facility GMP assessment using Form 20; on satisfactory assessment, the NDA issues a GMP compliance certificate.

Manufacturing must be carried out by a qualified pharmacist and supervised by the declared pharmacist. Quality control and quality assurance must be supervised by a team of qualified registered pharmacists recognised by the NDA, and the person in charge of production may not also be in charge of QC/QA. The current licensing guidelines further state that each production line and QC/QA must be supervised by a registered pharmacist resident in Uganda.

— Contact the NDA for guidance before construction of a new facility; do not begin production merely because the building is complete or the company has been incorporated.

— Check product registration for the medicines proposed for manufacture; if a change to the formulation, label or registration information triggers a variation, apply separately in accordance with NDA requirements.

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Individual pharmacist registration and business licensing must be handled separately. Retail/wholesale pharmacy applications use the supervising pharmacist's registration documents; current guidelines also require retail applications to submit proof of annual membership of the Pharmaceutical Society of Uganda and evidence for auxiliary staff. The supervising pharmacist should identify in writing the professional auxiliary staff assisting during business hours and is responsible for ensuring that auxiliary staff who handle medicines are registered.

The pharmacists in charge of production, QC or QA at a manufacturing facility must hold valid registration with the Pharmacy Council of Uganda. The competence guidelines additionally require at least two years of practical or regulatory experience in a licensed manufacturing/quality role or in medicine quality control/GMP inspections; the production and QC heads must remain independent at all times.

— First verify individual registration, annual status, proposed role, actual residency/supervision arrangements and auxiliary staff credentials.

— A supervising pharmacist for a retail/wholesale pharmacy may hold at most two licences issued in their name; confirm the specific arrangement with the NDA.

Before applying for a manufacturing, retail or wholesale premises, obtain location approval from the NDA, then apply for a certificate of suitability of premises. Location approval is valid for three months and may be extended once for reasonable cause; the 2021 amendment regulations also expressly state that the NDA considers only certificate-of-suitability applications for which location approval has been granted. Both the certificate of suitability and business licence must be applied for; the former is not the latter.

The 2021 regulations prescribe separate certificate-of-suitability formats for manufacturing, wholesale and retail, showing the physical location, address, TIN, issue date and valid-until date, and require prominent display at the relevant premises. Retail, wholesale and manufacturing premises must each pass inspection against the applicable minimum standards; the materials reviewed do not provide a nationally uniform floor area or capital threshold that can safely be applied.

— Submit a premises plan with a new application; where human and veterinary medicines are handled, the sections must be segregated.

— The premises sign should clearly state the name and type of business, for example, a human or veterinary retail pharmacy or wholesale pharmacy.

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Applications for certificates of suitability of premises and business licences for manufacturing, retail and wholesale are submitted through NDAMIS. Pharmacy applications typically upload both types of forms, proof of payment of prescribed fees, the supervising pharmacist's registration/annual membership evidence, undertakings or registration information for the supervising and auxiliary staff; new pharmacies also upload company or partnership documents, premises plans and a URA TIN, according to entity type. Incomplete new retail or wholesale applications will be rejected.

After a complete application and payment, the NDA inspects proposed retail or wholesale premises and assesses them against the applicable standards; if approved, it notifies the applicant and issues the business licence, and if refused, it gives written notice. Manufacturing applications must separately include product, personnel and GMP information, and the facility must undergo a GMP assessment.

— Step 1: Determine whether the activity is retail, wholesale, manufacturing, and whether human and/or veterinary medicines will also be handled.

— Step 2: Obtain site approval, prepare the premises suitability certificate and business licence documents, then submit them through NDAMIS.

— Step 3: Cooperate with inspections and respond to requests for corrections or information; do not operate until the actual licence has been issued.

The current NDA licensing guide states that licences issued under it are valid for three calendar years; renewal applications for manufacturing, wholesale and retail licences should be submitted at least three months before expiry. The NDA annual report also states that the pharmacy licensing cycle has changed from one year to three years. The three-month site approval, which may be extended once, must not be confused with the three-year business licence term.

Pay the prescribed fee when applying, but payment does not constitute the grant of a licence. The licensing and cross-border guides reviewed refer to “prescribed fees”; this research did not verify individual retail, wholesale, manufacturing, GMP, import or verification rates against the current fee regulations. Accordingly, no amounts are provided and no processing timelines are promised. Refer to the invoice generated by NDAMIS and the NDA’s current fee schedule.

— Set separate reminders for site approval expiry, the three-month-before-expiry licence renewal deadline, personnel credentials, and product registration/cross-border permit status.

— Budget separately for official fees, inspection-related remedial work, testing/quality systems, document notarisation and translation, and logistics.

Each January, licensed pharmacies must submit information to the NDA using the “Pharmacy Business Particulars Return Form”. If any particulars reported in the previous return change, the operator must notify the NDA in writing within 21 days of the change. At renewal, if an inspection identifies expired medicines, the operator must submit proof that they were destroyed in accordance with NDA procedures before the licence is issued. The premises must display a clear sign indicating the business category.

Retail, wholesale and manufacturing operations must each maintain the applicable personnel, premises and quality-control conditions. Statutory traceability records for retail and wholesale must be retained for at least five years. Manufacturing QA must ensure that each batch complies with registration and GMP requirements and certify the batch before release, marketing or export. The NDA may suspend or revoke a licence or certificate under the licensing regulations.

— Continuously verify the qualifications and actual roles of the supervising pharmacist, support staff, and production/QC/QA personnel.

— Establish inspection-ready records for procurement, batches, expiry dates, customers, rejected/expired products, destruction, and complaints/deviations.

A pharmacy may relocate only while holding a valid or renewable licence, and must obtain the NDA’s prior written approval before relocating. Relocation within the same district is permitted, subject to applicable distance rules. If a licensed pharmacy changes its supervising pharmacist, the company must demonstrate to the NDA that it has a pharmacist director. Changes to the location, business model or management arrangements should not be implemented first and reported afterwards.

A change in pharmacy ownership requires submission of the sale agreement, a certified board resolution approving the sale, and updated constitutional documents where applicable. The former licence holder should introduce the new owner in writing and surrender the old licence. The new owner must apply for a new licence for the pharmacy; the guide expressly states that the application is not subject to the conditions for a “new pharmacy”. Therefore, a share or asset transaction must never be described as automatically transferring the licence. For manufacturing, the QA lead must ensure that any change requiring an amendment to the product registration or manufacturing authorisation is notified to and authorised by the relevant authority.

— Before a transaction, check individually the registered entity, business address, licence holder, supervising pharmacist, product registrations, import/export entities and outstanding regulatory matters.

— When a relocation, change of responsible person, change in shareholding/control, or product/production change occurs, first obtain written confirmation from the NDA on the applicable procedure and retain records of submissions and approvals.

An applicant for a verification certificate for each consignment of registered medicines to be imported must hold a valid general or restricted import/export licence and submit the application electronically through NDAMIS. The NDA checks the product’s registration status in the current register, the manufacturing facility’s current GMP status, any applicable variation approvals, and the authorisation of the local technical representative (LTR). Import applications are generally accompanied by a pro forma invoice from the supplier, authorised by the local agent; additional documents are required for donations or medical camps. Product registration/marketing authorisation is not a retail, wholesale or manufacturing premises licence.

A verification application for imported raw materials or packaging materials must be made by an entity authorised under a Ugandan manufacturing licence. In addition to checking registration/GMP status, export of registered medicines requires verification of the certificate of analysis for each batch/lot; re-export also requires the NDA import cargo authorisation report issued at entry. Narcotic drugs, psychotropic substances and precursors require a separate import authorisation application. Unregistered medicines follow the “Special Case” import/export verification pathway in NDAMIS. The system guidance requires the premises to hold a valid licence and to have an annual or temporary import/export permit in place first; this is not a commitment to automatic approval for all unregistered commercial products.

— Verify each SKU: registration status, manufacturer’s GMP status, LTR, import/export licence, pro forma invoice and verification certificate for each consignment.

— Controlled drugs: prepare separate authorisation applications for narcotic drugs/psychotropic substances/precursors in addition to ordinary import/export or business licences.

— Select the corresponding NDAMIS pathway separately for raw materials, packaging materials, finished products, donations, medical camps and re-exports.

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