Mandate of the Directorate

The Directorate of Inspectorate and Enforcement is responsible for ensuring compliance with the laws and regulations that apply to the manufacture, control and supply of medicines and healthcare products including; human, veterinary, medical devices, natural health products and blood& blood products on the Ugandan market.

Inspectorate and enforcement activities are a crucial foundation of safeguarding the drugs and healthcare products which Ugandans have access to

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Director Inspectorate & Enforcement Services
Dr. Denis Mwesigwa

Chief Regional Inspector of Drugs
Dr. Tamale James Williams

Head Enforcement

Kyomukama Samuel

Units under the DIrectorate

GMP Inspectors conduct inspections of pharmaceutical manufacturers to assess compliance with NDA guidance on Good Manufacturing Practice (GMP) and the relevant details contained in marketing authorizations. They ensure that medicines supplied in Uganda meet consistent high standards of quality, safety and efficacy.

Foreign manufacturing sites are also required to pass an inspection prior to approval of the marketing authorization application. Following approval, a risk-based inspection program maintains on-going surveillance of domestic and foreign manufacturing site compliance with NDA GMP.

GMP Inspectors are responsible for inspecting and authorizing a range of manufacturers of sterile and non-sterile dosage forms, biological products, herbal products and active pharmaceutical ingredients, in addition to analytical laboratories.

The safety and quality of human blood for transfusion, or for further manufacture into blood-derived medicines, is ensured through inspections of relevant collection, processing, testing and storage activities at Blood Establishments and Hospital Blood Banks. These inspections assess compliance with global regulatory requirements, which take into account the detailed principles of GMP.

Products are allowed entry into Uganda 0nly through gazetted ports of entry. Application for import permit is done online through the NDAMIS portal for licensed premises.

The Import operations, typically focus on issuance of verification certificates following application reviews, Port of entry Inspections and sampling. After the port of entry inspections, a decision of either goods authorization or rejection is issued.

In addition to getting safe effective and quality products to the market, NDA must ensure that the products currently on the market remain safe and effective.

NDA maintains a system of post marketing surveillance(PMS) and risk assessment programs to identify quality as well as safety and efficacy concerns that did not appear during the drug approval process. The Authority uses this information to update drug labeling, and occasionally to reevaluate the approval or marketing decision. NDA maintains both reactive and proactive PMS systems including receipt of complaints as well as annual surveys

Our post market surveillance program consists of problem identification, problem assessment, and public-health response.

The eight (8) Regional offices conduct inspections for purposes of support supervision, issuance of certificates of suitability of premises and licensing of retailers and wholesalers.

Inspectors conduct inspections of sites of wholesale premises to assess compliance with Guidelines on Good Distribution Practice (GDP) and the conditions of a wholesale license.

Inspectors will ensure that medicinal products are handled, stored and transported under conditions as prescribed by the marketing authorization or product specification.

Inspections are undertaken for new applicants and renewals, then subsequently on a routine schedule based on a risk assessment of the site.

As part of its regulatory responsibilities, NDA monitors compliance, undertakes enforcement activities and works towards preventing non-compliance

Enforcement actions include any actions NDA takes to compel or induce compliance in order to mitigate the risk identified by non-compliance with the Act.

Upon completion of an investigation, the NDA may use a range of sanctions, including the issuance of a warning letter or a formal caution. It can suspend, revoke or vary the authorizations held by the manufacturers and distributors of medicines. NDA may pursue criminal proceedings in appropriate circumstances

Key Activities

  • Inspections of manufacturing facilities
  • Premises inspection and licensing
  • Support supervision
  • Compliance verifications and investigations (including recalls and public advisories)
  • Control imports of medicines &healthcare products in collaboration with the Uganda Revenue Authority (URA)