Regulatory Notice : Interim arrangements for regulatory laboratory testing
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Regulatory Notice : Interim arrangements for regulatory laboratory testing
The Pharmacy and Poisons Board (“the Board”) is established under section 3 of the Pharmacy and Poisons Act, Cap. 244 of the Laws of Kenya (“the Act”) under the Ministry of Health. The Board is primarily mandated to regulate the profession of Pharmacy and to ensure access to safe, quality and efficacious health products and technologies in Kenya.
Legal Framework
1. Section 3B(2)(k) of the Act mandates the Board to “prescribe a system for the sampling, analysis and other testing procedures of finished medicinal products released into the market to ensure compliance with labeled specifications”.
2. Section 3B(2)(r) of the Act authorises the Board to collaborate with national, regional and international institutions on the regulation of medicinal substances. 3. Further, Section 35D of the Pharmacy and Poisons Act (the “Act”) establishes the National Quality Control Laboratory (“NQCL”) as a facility for, among other functions, testing locally manufactured and imported drugs or medicinal substances, at the request of the Board and on behalf of the Government, to determine compliance with the Act and the rules made thereunder
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