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

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

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 in eCTD format. Please also take note of the new v2.0 trigger file that was uploaded for use on the SAHPRA website in May 2024.

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Document Number: HPA-15
Version: 5
Date Updated: 09/07/2024
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, HPA