HPA Archives - Page 5 of 6

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...

06 Mar Communication to Industry – Implementation of Regulatory Information Management System

Posted at 19:38h in

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 in

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....

15 Mar Communication on Hard Copy Registration Certificates

Posted at 11:46h in

Please note that SAHPRA will continue to communicate registration certificates for both new medicines and relevant type || variation applications via e-mail to applicants until further notice....

17 Feb Communication to Industry – Pilot Application Process through the SAHPRA Service Desk

Posted at 09:22h in

As you are aware SAHPRA has embarked on a process to digitalise its business processes. We have recently concluded a pilot application process with Lot Release Testing Requests through the SAHPRA Service Desk and would like to kick off a process for taking in our...

22 Jun Renewal of Human and Veterinary Medicines Requirements and Process

Posted at 14:17h in

This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: Annexure 1: Renewals Process Flow Diagram...

22 Feb Multiple Applications Guideline

Posted at 09:57h in

This guideline is intended to provide recommendations to applicants wishing to submit multiple applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an...

01 Feb SAHPRA Pre-Submission Meeting Request Form

Posted at 09:51h in

2021 Aug...

25 Jan BAU Variations Communication

Posted at 10:36h in

This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...

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