Payment of Retention Fees for the Financial Year Ending 31 March 2022 in Respect of Medicines Registered Up and Until 31 December 2020 and/or Manufacture or Wholesale Licences...
This communication intends to clarify the expectation for Good Clinical Practice (GCP) training post COVID-19 pandemic and supersedes the communication dated 13 April 2020 regarding online SA GCP training....
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...
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...
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...
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....
This document is intended to provide communication to the Medical Device Establishment Licence Industry in relation to the Appointment of Yellow Clip Financial Services....
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....
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....
