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GUIDELINE ON REGISTRATION OF HEALTH SUPPLEMENTS IN KENYA

Issued by the Pharmacy and Poisons Board (PPB), this guideline provides the regulatory framework for the  marketing authorisation of health supplements in Kenya. It establishes requirements to ensure that supplements are safe, of acceptable quality, and appropriately labelled, while clearly distinguishing them from medicines.

Scope

Applies to all health supplements intended for importation, manufacture, sale, or distribution within Kenya.

Main Content

• Application Requirements– dossier submission with product composition, manufacturing details, quality control measures, safety information, and labelling.
• Evaluation Criteria– safety (toxicological profile, history of safe use), quality (GMP compliance, stability data, specifications), and accurate representation of ingredients.
• Labelling & Claims– labelling and allowable health maintenance or nutritional claims. Specific annexures provide permitted dosage ranges and claim wordings for various categories of supplements.
• Post-Market Surveillance of food supplements

Objective

To regulate the safe use and fair marketing of health supplements, safeguarding public health while facilitating access to beneficial products.

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