News Flash
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Head Offices
Pharmacy and Poisons Board offices along Lenana Road in Nairobi. The building was officially opened in 2005 by the Minister of Health at the time, Hon. Charity Ngilu. -
PV Launch
Pharmacovigilance department came out to the Kenyan public on the 9th of June 2009 when a formal launch of the Pharmacovigilance System in Kenya took place at the Panafric Hotel in Nairobi. -
NQCL
National Quality Control Laboratory. The quality of a drug is one of the criteria for market approval. Quality assurance covers all activities aimed at ensuring that consumers and patients receive a product that meets established specifications and standards of quality, safety an efficacy. -
Ministry of Health HQ
Pharmacy and Poisons Board is under the Ministry of Health whose HQ are at Afya House, Bishop Road, Nairobi -
Guidelines
The Pharmacy and Poisons Board has various guidelines that explain how services are delivered. The guidelines can be downloaded from this site.
Medical Devices
REQUEST FOR COMMENTS ON MEDICAL DEVICES REGULATION
Medical Device Regulation in Kenya will be supervised and directed by Kenya Pharmacy and Poisons Board (PPB). Classification, requirements and evaluation of Medical Devices will be mainly simulation of rules and regulations recognized by the international regulatory benchmarks, which are mainly:
The Pharmacy and Poisons Act Chapter 244 of 2002
Global Harmonization Task Force (GHTF) for Medical Device EU Medical Device Directives 93/42/EEC,
EU In Vitro Diagnostic Device Directive (IVDD) 98/79/EC and EU Active Implantable Medical Device Directive (AIMDD) 90/385/EEC.
US FDA (United States Food & Drug Administration)
Australia TGA (Therapeutics Goods Act)
The regulation of medical devices in Kenya is aimed at maintaining balance between ensuring product safety, quality and effectiveness and providing the public with timely access to medical devices and preventing the entrance of unsafe or ineffective devices into the market.
Medical Devices Regulation Guidelines: DOC
Application Form for Registration of Medical Devices: DOC
Template for Medical Devices: XLX
The Board requests for you comments on the above documents. Please send your comments to drugreg@pharmacyboardkenya.org