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Guideline for Submission of Variation Applications for Registered Human Products

This guideline is meant to inform the applicant on how to submit variation applications of registered human products as per Cap 244 laws of Kenya to the Pharmacy and Poisons Board.

This document will simplify and streamline the process for submitting post-approval changes.

Applicants should start by reading through this document with reference to the conditions and documentation required. Thereafter applicants should submit a variation application form using the application template in Annex 1.

This is a living document and will be updated frequently as experience is gained through the processing of variations.

This guideline primarily covers the conditions to be fulfilled, documentation required, and the format of submission of variations applications for registered medicines. This guideline does not apply to vaccines and biological products.

PPB may request the applicant to furnish additional information, material, or define conditions not provided for in this guideline that may be deemed necessary to assist in the evaluation of submitted variations.

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