General ECTD & human medicines Archives - Page 16 of 23

09 Jul Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use

Posted at 11:58h in

This document is intended to provide communication to applicants on system updates regarding the Regulatory Information Management System (RIMS) Portal and the Digital Variations Portal (DVP). SAHPRA’s digital transformation has progressed as planned with submissions via the sFTP for new product applications, all variations, and renewals...

01 Jul Template of Amendment Schedule to APIMF Holder

Posted at 11:37h in

The template of Amendment Schedule to APIMF holder is for API suppliers to complete to indicate any changes in the APIMF....

06 Jun ZA-SAHPRA CTD eSubmission Specification – Document for comment

Posted at 20:25h in

The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...

28 May Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress

Posted at 15:18h in

This communication is intended to provide an update on the progress of the Regulatory Information Management System (RIMS) deployment at the South African Health Products Regulatory Authority (SAHPRA)....

22 May Letter of Permission from HCR

Posted at 12:02h in

To be printed on the letterhead of the Holder of the Certificate of Registration...

22 May Declaration of Sameness for Clones and Replicas

Posted at 11:59h in

To be printed on the letterhead of the proposed Holder of the Certificate of Registration...

14 May CEP Letter of Access Template

Posted at 11:29h in

The CEP Letter of access must be drafted on the latest approved SAHPRA letterhead...

30 Apr Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format

Posted at 11:22h in

During the recent webinar engagements, we have had several applicants raise questions seeking clarity around the appropriate process to follow for submitting Responses to queries that have been shared by SAHPRA for their review, action and response – for either new medicine applications or variation...

30 Apr Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress

Posted at 09:46h in

We want to provide a general update on the progress of the RIMS deployment that commenced at the end of March 2024. We have completed our migration processes for all eCTD applications and the priority eSubmission applications that were a work in progress – with some...

29 Apr EDQM CEP 2.0 Implementation

Posted at 08:28h in

This document is intended to provide communication to industry on the changes of EDQM CEP and implementation of CEP 2.0 for all other new applications for orthodox medicines. This will be a “living document” and will be updated in line with changes observed from the...

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