Veterinary Surgeons and Veterinary Paraprofessionals (Veterinary Medicines Directorate) Regulations, 2015 (L.N. No. 209 of 2015).

These Regulations, made under section 6 (2) (f) of the Veterinary Surgeons and Veterinary Para-professionals Act, 2011, establish the Veterinary Medicines Directorate and regulate the manufacture, importation, exportation, registration, distribution, prescription and dispensing of veterinary medicines (including veterinary pesticides) and the practice of veterinary pharmacy in Kenya. They shall apply to all conventional and alternate veterinary medicine but not to a specified type of vaccine and animal foodstuff supplements with no therapeutic claim.
The Directorate shall be a body corporate and its functions shall include, among other things: (a) to formulate and enforce quality assurance standards in the in the manufacture, distribution and use of veterinary medicines to safeguard human and animal health and the environment; (b) in consultation with the Director of Veterinary Services, to regulate the use of veterinary medicine for the treatment of animals under the Animal Diseases Act; (c) to consider applications for approval for market authorization of veterinary medicines. The Directorate shall also appoint veterinary medicine inspectors.
A person shall not import, manufacture sell, transport or distribute any veterinary medicine in Kenya unless that veterinary medicine has been registered with the Council of the Directorate in accordance with the provisions of these Regulations. There shall be a Veterinary Medicines Registration Committee, which shall be responsible for matters relating to registration. The Cabinet Secretary shall classify veterinary medicines in the classes set out in Part I of the Second Schedule and categorize veterinary medicines as set out in Part II of the Second Schedule. A veterinary pharmacy may be conducted alongside complementary businesses including the sale of human medicines, horticultural chemicals, agro-forestry chemicals and fertilizer, animal foodstuffs, seeds and agricultural equipment.