Archive

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...

Read More

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...

Read More

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...

Read More

11 Apr SAHPRA IB Sealing and Unsealing

Posted at 14:07h in

Read More

22 Mar Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 1965

Posted at 13:47h in

This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Applicants are required to comply with the provisions of the Act and Regulations....

Read More

08 Mar Collection of Outstanding Retention Fees

Posted at 17:02h in

This document is intended to provide communication to the Medical Device Establishment Licence Industry in relation to the Appointment of Yellow Clip Financial Services....

Read More

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....

Read More

06 Mar Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation

Posted at 11:16h in

Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....

Read More

29 Feb Minimum Requirements For Establishment of Internal Rules

Posted at 13:06h in

This document is intended to provide communication to applicants and holders of authorities of activities regulated by the Hazardous Substances Act, Act 15 of 1993 and amended regarding the requirements for internal rules that must be drawn up terms of Regulation 7 of the Regulations...

Read More

02 Jan COVID-19 Clinical Trials – Two-Weekly Progress Reports

Posted at 11:30h in

COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...

Read More