National Drug Policy and Authority (Registration) Regulations, 2014 (S.I. No. 29 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, provide with respect to the registration of (a) human and veterinary drugs and preparations including herbal medicine products for human and veterinary use; (b) vaccines and other immunological products for human and veterinary use; and (c) surgical instruments. All products shall be registered in Uganda before sale or distribution but person who intends to manufacture, import or export a product shall, prior to the manufacture, importation or exportation of the product, apply to the Authority for registration of the product. The National Drugs Authority shall maintain a register of the drug or preparation, vaccine or other immunological products registered under these Regulations, in the format specified in Schedule 1 to these Regulations. The applicant shall provide information on the residue studies carried out on the product where it is administered to food producing animals to enable the Authority to investigate specified elements. The applicant shall provide information relating to the assessment of toxity to the environment.