Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix

Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix

This document is intended to provide an update on the document matrix to be utilised by all applicants submitting applications for the Renewal of the certificate of registration from 22 January 2025. The Document Matrix location is as follows: https://ectd.sahpra.org.za/

 

Reference is made to ZA-SAHPRA eCTD Specification, SAHPGL-HPA – Renewal of Human and Veterinary Medicines Requirements and Process and GLF-HPA-04A – ECTD Validation And Technical Screening For Renewals.

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Document Number: HPA15-2025/26
Version: 10
Date Updated: 30/01/2025
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, HPA