See full address and map. See full address and map. Pharmacy Medicines And Poisons Board Phone and Map of Address: Lilongwe, Malawi, Malawi, Business Reviews, Consumer Complaints and Ratings for Pharmacies in Malawi. This document will simplify and streamline the process for submitting post authorization changes in manufacturing or chemistry. See full address and map. See full address and map. Address: Ndola, Zambia, Zambia. Address: Ridgeway, Lusaka, Zambia, Zambia. Surgical preparations such as catgut, plaster of Paris, bandages and artificial heart valves. Address: Kitwe, Zambia, Zambia. Login; Register; Home; Report a Suspected Adverse Drug Reaction; Report a Suspected Poor Quality Medicine; Feedback; Pharmacovigilance Electronic Reporting System Pink and Yellow Forms. Contact Now! Address: Luanshya, Zambia, Zambia. 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 2002Global 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. These issues include;a) Misconception amongst herbalists that documentation requested for by PPB is intended to steal their indigenous knowledge and thus, there has been hesitation to submit applications.b) Lack of documented evidence on quality, safety & efficacy of Herbal and complementary productsc) Unethical practices that include: d) Poor standards of preparation/manufacture and sale of herbal and complementary products. OBJECTIVE OF THE GUIDELINE This guideline is a document meant to assist pharmaceutical manufacturers in filing various variations of registered human products as per Cap 244 laws of Kenya submitted to the Pharmacy and Poisons Board. Amendments of 2002 to make rules under which medicines may be imported, manufactured for sale or sold in Kenya.PREPARATIONS LIABLE TO REGISTRATIONProducts claimed to be useful for any of the following purposes: This guideline presents a common format for presentation of a well-structured application for registration of herbal/complementary medicines to be submitted to Pharmacy and Poisons Board. Kenyans can identify legitimate pharmacies through SMS The Kenya Pharmacy and Poisons Board (PPB) a body which regulates the manufacture and sale of drugs and poisons within the country has so far closed down 994 illegal pharmaceutical outlets and arrested 881 offenders in a … SCOPE OF THE GUIDELINE This guideline primarily covers the conditions to be fulfilled, documentation required and the format of submission of a variation. Special arrangement has also been made with the building management office to enable persons with disability to gain access to our office. See full address and map. Medical Device Regulation in Kenya will be supervised and directed by Kenya Pharmacy and Poisons Board (PPB). The Act has given the board the power to operate as a body corporate. Amendments of 2002 to make rules under which medicines may be imported, manufactured for sale or sold in Kenya. Preventing or interfering with the normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing, postponing, increasing or accelerating the operation of that function, in human beings and animals. DOD. Barrier free access facilities at the office premises of the Board Secretariat include lifts.