Archive
09 Jul Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use
Posted at 11:58h
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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...
06 Jun ZA-SAHPRA CTD eSubmission Specification – Document for comment
Posted at 20:25h
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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
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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
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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
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To be printed on the letterhead of the proposed Holder of the Certificate of Registration...
30 Apr Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format
Posted at 11:22h
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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
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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...
06 Mar Communication to Industry – Implementation of Regulatory Information Management System
Posted at 19:38h
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As you are aware, SAHPRA has been focused on progressing the digital transformation of the organisation over the past few years. We have different initiatives underway to digitalise our business processes....
31 May Communication to Industry – Health Products Register Notification
Posted at 11:04h
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This document sets out to serve as a notification to all stakeholders on the status of the Health Products Medicines Register. This is a "living document" and will be updated as required. This communication is an interim document....