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

Subject

Livestock, Cultivated plants, Waste & hazardous substances

Keyword

Animal health Drugs Registration International trade Inspection Pesticides Hazardous substances

Geographical area

Africa, Eastern Africa

Abstract

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.

Full text

English

Website

www.kenyalaw.org

References - Legislation

Implements

Pharmacy and Poisons Act (Cap. 244).

Legislation | Kenya | 1957 (2002)

Keyword: Basic legislation, Animal health, Drugs, Authorization/permit, Internal trade, International trade, Pesticides, Registration, Hazardous substances

Source: FAO, FAOLEX

Repealed by

The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, Legal Notice no. 100 of 2022.

Legislation | Kenya | 2022

Keyword: Animal health, Authorization/permit, Packaging/labelling, Public health, Registration, Vaccination, Drugs, Plant production

Source: FAO, FAOLEX