National Drug Policy and Authority (Licensing) Regulations, 2014 (S.I. No. 35 of 2014).

These Regulations, made by the Minister responsible for health under section 64 of the National Drug Policy and Authority Act, and on the advice of the National Drug Authority, generally provide with respect to the licensing of a business concerning the manufacture of or trade in drugs. A person shall not without a licence — (a) operate as a licensed seller or import or export drugs; or (b) carry on the business of manufacturing or supplying by wholesale or retail of drugs. Licences shall be issued by the National Drug Policy and Authority. There shall be various classes of licences to sell (veterinary) drugs and a licence to manufacture drugs. Drugs may be imported by persons licensed as a wholesale seller. The Authority shall, for the purposes of assessing the manufacturing practices of the manufacturer, adopt with the necessary modifications, internationally accepted Good Manufacturing Practice Guidelines. A manufacturer who manufactures drugs in Uganda or outside Uganda for importation into Uganda shall comply with the Good Manufacturing Practice Guidelines adopted by the Authority.