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.


Download Version 3 (9.125)

Date updated

2022 Sep

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File Type: pdf
Category: Communication to industry, Guideline
Unit: General ECTD & human medicines