Author: Ntokozo Msiza

7 December 2021 Please note that the SAHPRA office will be closed for the festive season from 12h00 on Friday the 24th of December 2021 and will re-open on Monday the 3rd of January 2022. In case of emergencies kindly contact the respective Senior Managers. Medical Devices and...

30 September 2021 Attention all stakeholders Post Importation Testing Exemptions (PITE) granted due to COVID-19 pandemic Post importation testing exemption approvals granted since March 2020 due to the Covid-19 pandemic, are extended to March 2022 without further need of an application thereof. Post-Importation Testing Exemptions (PITE) expiring prior to...

3 September 2021 The South African Health Products Regulatory Authority (SAHPRA) is aligned with the United States Food and Drug Administration (USFDA) call to not use Ivermectin for the treatment of COVID-19. This stance is reflected in the SAHPRA statement, dated 28 January 2021, outlining SAHPRA’s views on Ivermectin and the Controlled Compassionate Use Programme.  SAHPRA...

26 July 2021 The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis/pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of...