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....
This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
SAHPRA requests electronic submission of the latest PSMF by 12 November 2025, including PV staffing details and a list of registered and marketed products. Submit via email to GVP@sahpra.org.za with the specified subject line....
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....
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....
This guideline intends to narrate the critical framework of sealing and unsealing hazardous substances. It stipulates all enforcement actions necessary, according to the Hazardous Substance Act, 15 of 1973 with respect to Grouped Hazardous Substances, related regulations and prescribed licence conditions, that may be imposed...
This letter shows routine inspection was carried out at a premises....
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....
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....