Guidelines for Registration and Licensing of premises

The Pharmacy and Poisons Board is the National Medicines’ Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board is mandated to regulate the profession of Pharmacy, the manufacture and trade in medical products and health technologies. The overall goal is to maintain the required level of oversight while facilitating innovation and access to safe, effective and good quality medical products and professionals that are fit to practice.

Pursuant to the Pharmacy and Poisons Act, a person cannot carry on a pharmacy business in Kenya unless the premises have a current approval and all the holders of the financial interest in the pharmacy business are registered as pharmacists or enrolled as pharmaceutical technologists.

These Guidelines are intended to provide guidance to dealers in pharmaceuticals and the public on registration of premises and licensing of pharmaceutical business for purposes of manufacturing, storage and sale of medical products and pharmacy practice. It aims to highlight the minimum requirements for licensing and also guide through the licensure and registration process, how to apply for a pharmacy registration, and the types of licenses.

The guidelines are also intended to address challenges in the current practice environment, enhance implementation of current legislation, align licensing requirements with other PPB guidelines and respond to changes in technology.

These guidelines do not overrule the Law or the Regulations, and will be revised from time to time as policies are developed or amended to incorporate up-to-date practices.