Clinical Variations Fee Schedule and Explanatory Notes
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...
02 May Recommended Calculations of Contraception Duration After Completion of Therapy with Genotoxic Anticancer Medicines (Sanofi and Other Collaborators)
Posted at 06:29h
in
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed below would like to inform you about recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (including potential metabolites)....
02 May Important Medicine Safety Information Section 36 Approval – Phenylephrine Hydrochloric Injectiontm
Posted at 06:25h
in
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Abbott Laboratories SA (Pty) Ltd, would like to inform you that Phenylephrine hydrochloric injectionTM has been up scheduled from Schedule 1 to Schedule 4 status. However, Abbott is experiencing unforeseen delays in the implementation...
30 Apr South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic
Posted at 11:33h
in
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
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 Recommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines (Sun Pharma and Other Collaborators)
Posted at 11:13h
in
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed in the attached document would like to inform you about recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (Including potential genotoxic metabolites)....