Quality Variations

Quality Variations

This document is intended to provide Communication to Industry on post-registration quality variation general announcements and submission of exception codes.

 

The document contains information that the applicant should consider when submitting applications for review. This document includes general information applicable to application submissions and exception codes for variations applicable to South Africa.

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Document Number: PEM POST 04-2024/25
Version: 1
Date Updated: 11/11/2024
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, PEM Post-Reg