Before any drug or medical device can be marketed or sold in Kenya, it must be registered with the Pharmacy and Poisons Board (PPB) under the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules. Foreign manufacturers must work through a locally registered Kenyan representative to handle this process.
Fee Summary Table
| Item | Fee |
|---|---|
| Product registration (drugs) | Varies by category — locally manufactured vs. imported, generic vs. innovator |
| Product registration (medical devices) | Varies by device risk class |
PPB does not apply one flat registration fee across all products; charges differ significantly by product type, manufacturing origin, and risk classification. For an accurate quote, consult PPB’s current Schedule of Fees for Regulatory Activities or contact PPB’s product evaluation desk directly with your specific product category.
What You Need
- Product dossier (chemical, pharmaceutical, pre-clinical and clinical data, where applicable)
- Certificate of Pharmaceutical Product / GMP certificate
- Evidence of registration (or pending registration) in other jurisdictions, if available
- Local representative agreement (for foreign manufacturers)
- Valid wholesale dealer’s, manufacturer’s, or poisons licence, as applicable
