This document provides an overview of the safety regulatory decisions taken by SAHPRA during April - July 2022....
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....
This document is intended to provide guidance to stakeholders on the use of the newly implemented QOS and QIS....
This form is to be completed by the applicant/holder of a certificate of registration/principal from whom the document was purchased for submission in South Africa, based on which party submitted the dossier to the RRA....
The DHCPL is intended to inform healthcare professionals (HCPs) about a typing error in the PI and PIL. The Synthroid products with PI and PIL with the typing error will not be distributed in the country for human use. Thus, Abbot applied for a Section...
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This Annual Performance Plan (APP) for the 2023/24 financial year that has been developed by SAHPRA, represents the planned actions of the Board of SAHPRA to ensure that through their considered and responsible actions, they can, together with the staff at the Authority, assure and...
This document is for use of all products including Biologics and veterinary products, where the information is not applicable for the specific molecule; indicate "N/A". Veterinary medicine applicants are advised to also refer to the VICH guidelines....
This document is for use of all products including Biologics and veterinary products....
This document provides an overview of the safety regulatory decisions taken by SAHPRA during July - December 2022....