Archive
02 May Explanatory Note on Fees Payable for Technical Amendments Related to Quality
Posted at 14:37h
in
The SAHPRA fees that have been gazetted are implementable from 22 December 2020. The fees outlined in most cases are self-explanatory, however in the case of fees payable for technical amendments related to quality, there are several options listed which require clarity and hence the...
02 May Annual retention fee payment notification for year ending 31 December 2024
Posted at 14:30h
in
Payment of retention fees for the year ending 31 March 2024 in respect of medicines and/or various licences registered until 31 December 2023....
02 May Annual retention fee payment notification for the Financial year ending 31 March 2020
Posted at 14:29h
in
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences...
02 May Annual retention fee payment notification for the Financial year ending 31 March 2022
Posted at 14:24h
in
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...
30 Apr South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic
Posted at 11:33h
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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....
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...
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...