Pharmacy and Poison (Registration of Drugs) Rules (Cap. 244).

These Rules provide for the registration of drugs intended for human beings and animals and prohibit the import, manufacture for sale or selling of any drug in Kenya unless that drug has been registered in accordance with the provisions of these Rules. An application for registration of a drug shall be in Form 1 in the Schedule to these Rules. The Board shall consider the application made under rule 4, and, if it is satisfied of the safety, efficacy, quality and economic value of the drug, shall register the drug and issue a certificate of registration which shall be in Form 2 in the Schedule. The Board shall carry out an investigation on the pharmaceutical, pharmacological and other aspects of new drugs and may order the inspection of production premises before the issuing of a certificate of registration.