OBJECTIVE OF THE GUIDELINE
This guideline is a document meant to assist pharmaceutical manufacturers in filing various variations of registered human products as per Cap 244 laws of Kenya submitted to the Pharmacy and Poisons Board. This document will simplify and streamline the process for submitting post authorization changes in manufacturing or chemistry.
SCOPE OF THE GUIDELINE
This guideline primarily covers the conditions to be fulfilled, documentation required and the format of submission of a variation.
PPB may request the applicant to furnish additional information, material or define conditions not provided in this guideline which may be deemed necessary to assist in evaluation of submitted variations.
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