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....
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 template has been updated to conform to the new SAHPRA document format....
2022 Aug...
This template has been updated to conform to the new SAHPRA document format....
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines and variations. It represents the Authority’s current thinking on medicines' safety, efficacy and quality. It is not intended as an exclusive approach....