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25 May

Posted at 14:12h in

This document is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...

10 May

Posted at 10:20h in

This document provides guidance to the applicants/holders of Certificate of Registration on the pharmacovigilance system requirements. It is meant to facilitate compliance by applicants/HCRs with the regulatory authority on pharmacovigilance requirements....

06 May

Posted at 16:23h in

This document has been prepared to serve as a guideline to those involved in the conduct of Pharmacovigilance inspections. It is meant to facilitate compliance with Good Pharmacovigilance Practice relating to the conduct and monitoring of Pharmacovigilance inspections. It is not intended as an exclusive...

27 Apr

Posted at 16:43h in

This guideline is intended to provide guidance to applicants wishing to submit an appeal against all regulatory decisions that are administrative in nature.   Any person aggrieved by the decision of the Authority may appeal against such decision by notifying the Chief Executive Officer within thirty (30)...

14 Apr

Posted at 10:18h in

This guideline is intended to provide guidance to applicants wishing to submit new application for registration of biological medicines. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right...

22 Feb

Posted at 09:57h in

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...

02 Feb

Posted at 23:55h in

This guideline is intended to provide recommendations to applicants wishing to submit clinical applications for the registration of veterinary medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the quality, safety, and efficacy of...

26 Jan

Posted at 14:30h in

This document has been prepared to serve as a guideline to enable the direct payment of fees into the bank account of SAHPRA. It must be read together with the relevant Fees Regulations and the General Information guideline....

26 Jan

Posted at 14:03h in

This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial....