Guidelines for Registration of Herbal Products

Issued by the Pharmacy and Poisons Board (PPB) under the Ministry of Health, Kenya, this guideline provides the framework for the registration of herbal products intended for use in the country. It establishes requirements to ensure that such products meet standards of quality, safety, and efficacy, while recognizing their unique nature compared to conventional pharmaceuticals.

Scope

Applies to all herbal products intended for registration and use in Kenya, including traditional medicines and herbal preparations, whether imported or locally manufactured.

Main Content

• The document provides guidance on the preparation and submission of applications for the registration of herbal products. It specifies requirements for product information, manufacturing details, composition, quality control of raw materials and finished products, stability studies, and pharmacological or toxicological data.
• The guideline also highlights the need for compliance with Good Manufacturing Practice (GMP), labelling and packaging requirements.

Objective

The guideline aims to regulate the safe and effective use of herbal products, promoting their integration into healthcare while ensuring protection of public health through proper evaluation and oversight.