PPB Fees Kenya / Medicines and other health products
Medicines and other health products: PPB fees, timelines and our charges
PPB registration of pharmaceutical and other health products in Kenya, through PRIMS.
This covers finished pharmaceutical products and other health products registered with the PPB under the Registration of Health Products and Technologies Rules, 2022. Applications are compiled in the CTD format and submitted through the PPB PRIMS portal.
A manufacturer based outside Kenya must appoint a Local Technical Representative (LTR) to hold and manage the registration. Pharma Verixa acts as LTR directly as a PPB-licensed Scientific Office.
Government (PPB) fees
Statutory charges paid to the PPB, passed through at cost when we act for you.
| Item | Fee |
|---|---|
| Registration, product not made in Kenya | USD 1,000 |
| Registration, product made in Kenya | USD 500 |
| Renewal, product not made in Kenya | USD 1,000 |
| Renewal, product made in Kenya | USD 500 |
| Fast-tracked evaluation (imported) | USD 2,000 |
| NQCL sample testing and any GMP inspection | At cost |
Our professional charges
USD 1,000 per product
Our professional fee covers dossier evaluation and CTD compilation, PRIMS submission, one standard round of query response, and LTR representation for foreign applicants. The PPB statutory fee, NQCL sample testing and any GMP inspection are paid separately at cost.
Fees are indicative and open to discussion for the right fit, with volume and portfolio discounts by quote. Government fees are separate and billed at cost.
Request a quoteHow long registration takes
Typically 6 to 12 months from a complete dossier, depending on the PPB queue and any queries. A fast-tracked evaluation can shorten this.
When renewal is due
The registration certificate is generally valid for 5 years. Renew before expiry to keep the product on the market; the renewal fee matches the registration fee. Confirm the exact validity on your certificate.
Checklists for this category
Use these to prepare and gap-check your file before submitting through PRIMS.