Uganda's NDA registers every medicine before import and issues a permit for every consignment that follows

What the National Drug Authority controls

The National Drug Authority (NDA) is Uganda's medicines regulator, established under the National Drug Policy and Authority Act, Chapter 206 of the Laws of Uganda. It registers pharmaceutical products, licenses the premises that import, manufacture, wholesale and retail them, and inspects consignments at the point of entry.

No medicine may be marketed, distributed or sold in Uganda unless it is entered on the National Drug Register. Registration is separate from import licensing: a product can be registered and still require a valid import permit and a verification certificate before a specific shipment clears customs. Exporters preparing a submission for the first time can review the general logic in WHO prequalification vs national registration before mapping it onto Uganda's own steps.

Product registration through NDAMIS

The NDA's online platform is the National Drug Authority Management Information System, referred to on its own documentation as NDAMIS. Registration applications, license renewals and verification certificate requests are all submitted through this portal, with access credentials issued to the applicant or its appointed local agent.

A foreign manufacturer does not need to incorporate a company in Uganda to register a product. NDA guidelines require every applicant who is not resident in Uganda to appoint a local technical representative in Uganda, authorised by the NDA to deal in medicinal products, and to notify the Authority with a letter of appointment supported by a power of attorney notarised in the country of origin and registered with the Registrar of Companies in Uganda. M Care Exports works with the importer's appointed local technical representative to compile the dossier rather than attempting registration without one, since NDAMIS will not accept a foreign-manufacturer application on its own.

The Directorate of Product Assessment and Registration evaluates the dossier against national and internationally accepted quality, safety and efficacy standards, and also handles post-registration amendments and renewals once a product is on the register.

Who is allowed to import: the licensed premises requirement

Importing medicines into Uganda is a licensed activity tied to a physical premises, not an open-ended permission to bring in stock. A wholesale pharmacy or importing entity needs an NDA premises licence, a certificate of suitability of premises following inspection, and a registered superintendent or supervising pharmacist named on the licence.

Importers, wholesalers and distributors are also expected to operate under Good Distribution Practice. For an Indian exporter this means the counterpart placing the purchase order in Uganda, whether a private wholesaler, a hospital pharmacy or one of the public and faith-based procurement bodies described below, must hold a current NDA import licence before M Care Exports can ship against that order.

Import permits and the verification certificate per consignment

The NDA issues two categories of import permit, both applied for through NDAMIS. An annual import permit covers regular importers, such as licensed wholesale pharmacies or manufacturers, for ongoing trade across the calendar year in which it is issued. A provisional import permit is issued per consignment, valid for one month, and is aimed at non-regular importers such as organisations receiving a donation or individuals bringing in a limited quantity of a specialised medicine not otherwise available in the country.

• Every consignment, even under an annual permit, is subject to a separate verification certificate application, reviewed against the shipping documents before the goods move.
• Products are only permitted entry through gazetted ports of entry, so the shipping route has to match a designated port before booking.
• Port-of-entry inspection and sampling follow the verification review, ahead of release to the importer.

Because the permit and the verification certificate are two separate checkpoints, exporters should confirm both are in place with the Ugandan importer before goods are loaded, not assume that registration or an annual permit alone is sufficient for a given shipment.

National Medical Stores and Joint Medical Store: the two public-facing procurement routes

Two institutions dominate bulk procurement for Uganda's health system, and they serve different networks. National Medical Stores (NMS) is a statutory corporation established by Act of Parliament to procure, store and distribute essential medicines and medical supplies to public health facilities in Uganda, including facilities run by the police, army and prisons. NMS procures through centralised, tender-based processes and works with international vendors channelled through local distributors.

Joint Medical Store (JMS) is a private not-for-profit organisation established in 1979 by the Uganda Catholic Medical Bureau and the Uganda Protestant Medical Bureau. It is licensed by the NDA to import, warehouse and distribute medicines, and supplies the country's faith-based, private not-for-profit health network, reported at around 3,000 facilities. A supplier relationship with either body still runs through NDA registration and import licensing; NMS and JMS are procurement channels, not a substitute for regulatory clearance. Exporters weighing tender routes elsewhere in the region can compare notes with how KEMSA tenders work in Kenya.

Reliance pathways and the document pack from the Indian side

Uganda's NDA is one of the national regulatory authorities participating in the WHO Collaborative Registration Procedure (CRP), under which a participating authority can draw on the assessment and inspection reports already produced by a stringent regulatory authority or by WHO Prequalification to run an accelerated, verification-style review rather than a full independent evaluation. This applies where the product itself carries WHO prequalification or SRA approval; it is not a general shortcut for every generic dossier, and eligibility should be confirmed against the specific product before it is assumed.

From the Indian side, the exporter's document pack for an NDA submission typically runs alongside the CTD dossier itself: a WHO-GMP certificate or equivalent GMP evidence for the manufacturing site, a Certificate of Pharmaceutical Product from India's drug regulator, a free sale certificate, product-specific stability and analytical data, and the power of attorney appointing the Ugandan local technical representative. M Care Exports assembles this pack against each manufacturer's own certification rather than a generic template, since the manufacturing site named in the dossier has to match the site actually holding the GMP certificate. Where the CTD itself needs building or restructuring for the NDA format, that sits with dossier preparation and CTD compilation.

Frequently asked

Does a medicine need to be registered with the NDA before it can be imported into Uganda at all?

Yes. Uganda requires marketing authorisation, meaning entry on the National Drug Register, before a pharmaceutical product can be sold or distributed in the country. Registration is handled by the NDA's Directorate of Product Assessment and Registration through the NDAMIS portal. A small set of exceptions and waivers exist, such as named-patient or donation imports under a provisional permit, but routine commercial supply requires registration first.

Can an Indian manufacturer register a product in Uganda without a local company?

Yes. Uganda does not require the foreign manufacturer to incorporate locally. It requires the appointment of a local technical representative, a person in Uganda authorised by the NDA to deal in medicinal products, notified with a letter of appointment and a notarised power of attorney registered with the Registrar of Companies in Uganda. M Care Exports works through the importer's existing local technical representative rather than trying to register a product without one.

What is the difference between an import permit and a verification certificate?

The import permit authorises a licensed entity to import medicines generally, either annually for regular importers or provisionally, valid one month, for a single non-regular import. The verification certificate is a separate, per-consignment check applied for through NDAMIS ahead of each shipment, reviewed alongside the shipping documents before goods are released for entry through a gazetted port. Holding an annual permit does not remove the need for a verification certificate on each consignment.

Who can legally import medicines into Uganda: any registered company?

No. Importing is tied to an NDA premises licence, which requires a certificate of suitability of premises following inspection and a registered superintendent pharmacist named on the licence. A general trading company without a licensed pharmaceutical premises and a supervising pharmacist cannot hold an NDA import licence, regardless of its registration status for other goods.

What is the difference between National Medical Stores and Joint Medical Store as customers?

National Medical Stores (NMS) is the statutory corporation procuring for Uganda's public health facilities, including police, army and prison health services, mostly through centralised tenders. Joint Medical Store (JMS) is a private not-for-profit body owned by the Catholic and Protestant medical bureaux, supplying the country's faith-based and private not-for-profit facility network. Both are licensed importers in their own right; supplying either still requires the product to be NDA-registered and the shipment to clear NDA import and verification checks.

Does WHO prequalification speed up NDA registration in Uganda?

It can, for products that carry it. Uganda's NDA participates in the WHO Collaborative Registration Procedure, which lets a participating authority rely, fully or partly, on the assessment and inspection findings already produced by WHO Prequalification or a stringent regulatory authority, running a faster verification review instead of starting the evaluation from zero. This only applies to the specific products covered by that prequalification or SRA approval, not to every generic in a manufacturer's range.