Archive

Home > 

24 Jun

Posted at 17:55h in

This document is intended to provide communication to all Holders of Certificates of Registration (HCRs)/ Applicants about the mandatory submission of Post-marketing Adverse Event (AE) reports for human medicines through Industry eReporting VigiFlow module. The submission of post-marketing AE reports for human medicines is applicable...

10 Dec

Posted at 09:40h in

This is the third edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls and rapid alerts. This edition will provide information for the period October to December 2025....

18 Nov

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

25 Sep

Posted at 13:18h in

This is the second edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls and rapid alerts. This edition will provide information for the period July to September 2025....

14 Aug

Posted at 12:03h in

Welcome to the first edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls, and rapid alerts. This edition will provide information for the period April to June 2025....

19 Nov

Posted at 17:07h in

This letter grants permission to name of Technician of name of IB to remove the seal from the x-ray unit at the premises of the licence holder....

19 Nov

Posted at 16:58h in

This letter grants permission to the licence holder to remove the seal from the x-ray unit at the premises in the absence of the Radiation Inspector....