BAU Variations Communication

BAU Variations Communication

This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information Guideline for Variations. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. This document should be read in conjunction with SAHPRA’s revised guidelines and templates, available from SAHPRA’s website.

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Document Number: SAHPGL-HPA-05
Version: 4
Date Updated: 07/09/2022
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, HPA