Register a medicine or health product with PPB (marketing authorisation), and renew or vary it
Pharmacy and Poisons Board · sources read 3 Oct 2026
Apply online on the PPB products portal: pay the application fee (charged in US dollars), submit the full dossier and a valid GMP certificate, then answer PPB's queries on time. Once registered, pay the annual retention fee by 31 December and renew at least 3 months before expiry.
- Fee
- Registering a product costs USD 1,000 for a foreign product or USD 500 for a local maker. Keeping it registered costs USD 300 a year (foreign) or USD 150 (local).
- How long
- Imported medicines: up to 540 days of evaluation after the CTD number. Locally made: about 180 days. The clock stops while you answer queries.
- Deadline
- Annual retention fee due by 31 December every year
- Where
- Online on the PPB products portal (products.pharmacyboardkenya.org). Enquiries: drug_reg@ppb.go.ke; renewals: drugsrenewals@ppb.go.ke
What you need
- Complete product dossier (CTD format)
- Valid cGMP certificate, or payment for a GMP inspection
- Product samples, where PPB asks for them
Steps
- Log in to products.pharmacyboardkenya.org, pay the application fee and submit the full dossier with your cGMP certificate.
- Answer screening queries within 28 calendar days. You get up to 3 screening rounds.
- Send samples if asked. PPB then issues a CTD number and starts the full evaluation.
- Answer evaluation queries on time (first query within 180 days for new applications). PPB then decides and issues the registration certificate.
- Keep it on the register: pay the annual retention fee by 31 December, apply for any changes as minor or major variations, and renew before it expires.
Watch out
- Fees are in US dollars: routine registration is USD 1,000 for a foreign product and USD 500 for a locally made one. Retention is USD 300 foreign or USD 150 local a year.
- Miss a query deadline and the application lapses. You then have to start again and pay fresh fees.
- Submit a complete renewal at least 3 months before the current marketing authorisation expires.
Who can apply
- Companies (marketing authorisation holders and their local technical representatives) with human medicines, vaccines, herbal products, medical devices, blood products, supplements or cosmetics to sell in Kenya.
Official sources (5)
- Marketing Authorisation (Registration, Retention and Variations) web.pharmacyboardkenya.org · read 3 Oct 2026
- Customer Service Delivery Charter (Rev. 04, July 2026) web.pharmacyboardkenya.org · read 3 Oct 2026
- Regulatory notice: Query response timelines and review cycles for new and renewal marketing authorisation applications (25 Sept 2026) web.pharmacyboardkenya.org · read 3 Oct 2026
- Ports of Entry (site menu) web.pharmacyboardkenya.org · read 3 Oct 2026
- PPB products portal products.pharmacyboardkenya.org · read 3 Oct 2026