The Minister for Health in consultation with the Pharmacy and Poisons Board is empowered by section 44(1) of the Pharmacy and Poisons Act, Cap 244 and misc. Amendments of 2002 to make rules under which medicines may be imported, manufactured for sale or sold in Kenya.
PREPARATIONS LIABLE TO REGISTRATION
Products 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. This format of technical documentation will significantly reduce the time and resources needed to compile applications for registration of herbal and complementary products and will in future ease the preparation of electronic submissions. Evaluation of dossiers and communication with the applicants will be facilitated by a standard document of common elements. This guideline will ensure that only good quality, safe and efficacious herbal and complementary products are available in Kenya; and to contribute towards their accessibility, cost effectiveness and appropriate use with the current state of knowledge. This guideline has been drawn to address the many issues on the quality of herbal and complementary medicines that have been used for a long period of time in Kenya. 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 products
c) Unethical practices that include:
- Adulteration of herbal and complementary products with conventional medicines
- Advertising of Herbal and complementary products in print media, electronic and bill boards
- Peddling of products with no therapeutic benefits
- Unsubstantiated medicinal claims by herbal practitioners.
- Dealing with herbal products whose toxicological profile is not known
d) Poor standards of preparation/manufacture and sale of herbal and complementary products. This guideline will focus on the manufacture, registration and marketing of herbal and complementary medicines.
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.
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. This document will simplify and streamline the process for submitting post authorization changes in manufacturing or chemistry.
SCOPE OF THE GUIDELINE
This guideline primarily covers the conditions to be fulfilled, documentation required and the format of submission of a variation.
PPB may request the applicant to furnish additional information, material or define conditions not provided in this guideline which may be deemed necessary to assist in evaluation of submitted variations.