In Kenya, the Batch/Lot Release Certificate is a regulatory instrument issued by the Pharmacy and Poisons Board (PPB), established under the Pharmacy and Poisons Act, Cap. 244 of the Laws of Kenya. It is required for specified categories of pharmaceutical products — including vaccines, blood products, biological medicines, and certain controlled medicines — before each batch may be distributed in the Kenyan market. The batch release process verifies that each production lot meets the specifications registered with the PPB, providing an additional safety assurance layer beyond initial product registration.
Batch / Lot Release Certificate Fee Summary Table
| Fee Type | Amount | Notes |
|---|---|---|
| Batch/lot release certificate fee | As gazetted under Cap. 244 | Fees are prescribed by the Cabinet Secretary for Health under Section 44 of the Pharmacy and Poisons Act |
The PPB’s last full gazette of fees under the Pharmacy and Poisons Act was completed in 2010, and a revised schedule has been under consideration. Current fee amounts are communicated directly to applicants through the PPB regulatory process. Confirm the latest amounts with the PPB before submission.
Key Requirements
Applicants submit: batch manufacturing records, certificates of analysis from accredited quality control laboratories, summaries of in-process and end-product testing, and any deviation or incident reports for the batch. Submission is made to the PPB’s Product Regulatory Department through the PPB PRIMS online portal. PPB may additionally conduct or commission independent laboratory testing before issuing the certificate.
Contact
Pharmacy and Poisons Board (PPB)
Pharmacy and Poisons Board House, Lenana Road, Nairobi
P.O. Box 27663-00506, Nairobi
Website: pharmacyboardkenya.org
