This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: Annexure 1: Renewals Process Flow Diagram...
This guideline is intended to provide recommendations to applicants wishing to submit multiple applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an...
This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...
This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained....
This document provides recommendations to applicants wishing to submit applications for the variation of human and veterinary medicines. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive...
