Payment of retention fees for the year ending 31 March 2024 in respect of medicines and/or various licences registered until 31 December 2023....
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...
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...
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)....
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...
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...
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)....
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...