Validation Template For ECTD Variation Applications

Validation Template For ECTD Variation Applications

The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate a variation application for a medicinal product for human use submitted in eCTD format. It is also used for follow-up sequences that may be required for the variation. The applicant must ensure that all relevant fields are completed.

 

The implementation date is 01 July 2023.

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Document Number: GLF-HPA-03A
Version: 2
Date Updated: 16/05/2023
File Type: docx
Category: Templates
Unit: General ECTD & human medicines