How do I register a new herbal supplement in Kenya and what approvals are required?

Hello.

To launch a herbal supplement in Kenya you must register it with the Pharmacy and Poisons Board (PPB), which regulates health products including dietary/herbal supplements to ensure safety, quality and proper labelling. The process involves submitting a complete dossier (product composition, manufacturing details, quality/safety data, Certificate of Analysis, GMP evidence, samples of the product, proposed labelling with mandatory information like ingredients, batch, expiry, warnings, etc.) and paying the prescribed fees; imported products also need appropriate free sale/manufacture certificates from the country of origin. The PPB evaluates safety, quality, and claims and, if satisfied, issues a registration certificate typically within about 180 days after submission and responses to queries. Once registered, you must comply with ongoing requirements like renewals and safety reporting. Given the technical regulatory framework, documentation requirements and ongoing compliance, it’s generally beneficial to engage a lawyer or regulatory consultant to manage submissions, ensure correct classification/claims, handle interactions with PPB, and align labeling and safety data with Kenyan law.