Guidelines for Suspension, Withdrawal, Withholding and Revocation of Marketing Authorization of Medical Products and Health Technologies in Kenya

The Pharmacy and Poisons Board is established by law to protect and promote the health of the public by regulating the profession of pharmacy and ensuring access to quality, safe, efficacious and affordable health products and technologies (The Pharmacy and Poisons Act of 1957, Cap 244; and Health Act, 2017).

Marketing authorization also referred to as drug registration in Kenya started in 1982. Since the inception of marketing authorization, the board has made significant progress to secure the health of the public based on its mandate. It leverages on advanced science and technology and international best practices of marketing authorization that are intricately woven in robust strategies.

The guideline draws from lessons learnt as well as recent development in Kenya and globally to maintain a register of health products and technologies. Marketing authorization work has expanded remarkably and notable achievements include registration of medical devices, registration of blood products, issuance of conditional registration, growth of the workforce, automation and vigorous improvement of the quality management system.

This guideline reaffirms the Board’s commitment to assuring the highest attainable standard of health for all Kenyans as a right enshrined The Constitution of Kenya 2010. This document shall enable the Board not only to ensure access to affordable products that are of good quality, safe and efficacious, but also to remove products from the market that may cause a threat to public health. Towards this end, the Board will rely on a participatory and inclusive approach to ensure that stakeholders including manufacturers, traders, and healthcare professionals are proactively engaged and involved.

With this guideline, I am confident that the Board has established a strong pillar for the management of registers of medical products or technologies by way of suspension or revocation of marketing authorization certificates.