Register a medical device, IVD, herbal medicine or food supplement with PPB
Pharmacy and Poisons Board · sources read 3 Oct 2026
Apply online on PPB's PRIMS portal: submit the product dossier and pay the application fee, which is set in US dollars. A maker based outside Kenya must act through a local representative in Kenya.
- Fee
- We couldn't confirm a fee from the official page. Check it there before you pay.
- How long
- Herbal products: up to 180 working days for a complete application (no official time given for devices or supplements)
- Where
- Online on PPB's PRIMS portal (prims.pharmacyboardkenya.org)
What you need
- Herbal products: 3 samples of the smallest commercial pack from one batch, with batch certificates of analysis
- Herbal products: a site master file if the factory has not been inspected and approved by PPB
- Supplements: a copy of the legal authority (power of attorney) given to your local representative
- Medical devices: proposed labelling (actual artwork and packaging)
- Medical devices: regulatory approval from the product's country of origin
Steps
- Read the PPB guideline for your product type, fill in the application form, prepare the dossier and submit it on PRIMS (prims.pharmacyboardkenya.org).
- The application fee is charged as soon as you submit on the portal.
- Answer any request for more information from PPB. The clock stops until you reply.
- If the product meets the requirements, PPB registers it and lists it.
Watch out
- Fees are in US dollars. For example, the application fee for an imported herbal product is US$ 1,000.
- No herbal product is registered unless the factory meets current GMP; PPB may inspect it first.
- Food supplements: registration usually lasts five years, but you must renew (retain) it every year.
Who can apply
- The licence/patent holder, the manufacturer, or a local technical representative they have authorised
- A manufacturer based outside Kenya must appoint a local authorised representative
Official sources (4)
- Guidelines for Registration of Herbal Products (Rev. 2, January 2022) web.pharmacyboardkenya.org · read 3 Oct 2026
- Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics web.pharmacyboardkenya.org · read 3 Oct 2026
- Guideline on Registration of Health Supplements in Kenya (June 2025) web.pharmacyboardkenya.org · read 3 Oct 2026
- PPB Online Services Portal (PRIMS) prims.pharmacyboardkenya.org · read 3 Oct 2026