The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...
We are sharing a communication to provide a general update on the progress for the deployment of the Regulatory Information Management System (RIMS) that commenced at the end of March 2024....
To be printed on the letterhead of the Holder of the Certificate of Registration...
To be printed on the letterhead of the proposed Holder of the Certificate of Registration...
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...
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....
This document is set to provide a summary of the frequently asked questions regarding the Medicine Registration Renewals Process ensuring a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public....
This document sets out to serve as a notification to all stakeholders on the status of the Health Products Medicines Register. This is a "living document" and will be updated as required. This communication is an interim document....
Please note that SAHPRA will continue to communicate registration certificates for both new medicines and relevant type || variation applications via e-mail to applicants until further notice....