Query response timelines and review cycles for new and renewal marketing authorisation applications
- Version
- Download 15
- File Size 0.00 KB
- File Count 1
- Create Date September 25, 2026
- Last Updated September 26, 2026
Query response timelines and review cycles for new and renewal marketing authorisation applications
The Pharmacy and Poisons Board ("the Board") is mandated under the Pharmacy and Poisons Act, CAP 244 Laws of Kenya to protect and promote public health by ensuring access to quality, safe, and efficacious Health Products and Technologies (“HPTs”).
To support timely, predictable, and efficient processing of applications for Marketing Authorization of HPTs, the Board hereby reminds all Marketing Authorization Holders (MAHs) and Local Technical Representatives (LTRs) of the timelines for responding to regulatory queries for both New and Renewal Applications.
Response periods and review cycles
1. MAHs and LTRs must strictly comply with the query response timelines and maximum allowable review cycles set out below for both New Applications and Renewal Applications.
2. The response periods and review cycles below are drawn from Part VII, sections 5.2, 5.5 and 5.6 of the Compendium of Guidelines on Medicines Evaluation and Registration in Kenya and section 4.0 of the Guidelines on Renewal of Marketing Authorization for Medicines and Vaccines.
Attached Files
