Kenya Product Registration Route Finder
Answer a few questions and get the correct PPB registration route for your product, whether you need a Local Technical Representative, the dossier format the Board expects, and your first practical steps.
Class A to D sets how much evidence the technical file must carry.
Your route
Choose your product type and who you are, then select Find my route. Your registration path, representative requirement, dossier format, and first steps appear here.
Registration route
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Local Technical Representative
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Dossier format
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First steps
Not legal advice. This is planning guidance only. The PPB confirms the final product classification and registration route.
Registration routes in Kenya: FAQ
How do I know if my product is a medicine or a device?
A finished pharmaceutical works mainly through pharmacological, immunological, or metabolic action, so it registers as a medicine on the CTD dossier. A medical device achieves its main purpose by physical or mechanical means and registers on a technical file scaled to its risk class. Borderline products, such as a medicated dressing or a drug-device combination, are decided case by case, so confirm the classification with the PPB before you build the file.
Do foreign manufacturers need a local representative to register with the PPB?
Yes. A manufacturer based outside Kenya cannot hold a PPB registration directly. You must appoint a locally licensed Local Technical Representative to hold the registration and face the Board on your behalf. The Pharma Partner can act as your Local Technical Representative.
What dossier format does the PPB use?
Human medicines are submitted as a Common Technical Document, Modules 1 to 5, covering administrative, quality, non-clinical, and clinical information. Medical devices and IVDs use a technical file in the CSDT structure, with the depth of evidence scaled to the A to D risk class. Supplements and cosmetics use a product information file per the PPB requirements.
Where do veterinary products register?
Veterinary medicines follow the Veterinary Medicines Directorate route, not the human PPB medicines pathway. If your product is intended for animals, confirm the correct regulator early so you do not build a dossier for the wrong Board.
How product registration routes work in Kenya
Before any regulated health product can be sold in Kenya it must be registered with the correct regulator, and the route depends first on what the product is. The Pharmacy and Poisons Board (PPB) handles human medicines, medical devices, in vitro diagnostics, health supplements, and cosmetics, each on its own pathway through the PRIMS online portal. Veterinary products follow a separate route under the Veterinary Medicines Directorate. Getting the classification right at the start matters, because it sets the dossier format, the evidence you must gather, and often the timeline and cost of the whole project.
For human medicines the Board expects a Common Technical Document, or CTD, arranged as Modules 1 to 5. Medical devices and IVDs use a technical file in the CSDT structure, and the risk class, from Class A at the low end to Class D at the high end, decides how much clinical and performance evidence the file must contain. Supplements and cosmetics are lighter touch, registered or notified on a product information file, but they still need proper labelling, composition, and safety information. Whatever the category, an incomplete or mis-formatted dossier is the most common reason applications stall.
The second question is who can hold the registration. A manufacturer based outside Kenya cannot register directly and must appoint a locally licensed Local Technical Representative, sometimes called a Scientific Office, to hold the registration and answer to the Board. A local distributor or importer can often hold the registration itself if it carries the required PPB licence, and a local manufacturer registers directly under its own licence. This tool reads your two or three answers and maps them to the route, the representative requirement, the dossier format, and the first steps, so you can plan the engagement before you commit resources.
Ready to map your full registration roadmap?
We confirm your product classification, build the dossier in the format the PPB expects, and act as your Local Technical Representative if you are based outside Kenya. One partner from classification to approval.