16 Mar SAHPRA and the Pfizer/Biontech Comirnaty Vaccine
16 March 2021 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine. Download PDF ...
News & Updates
03 Feb SAHPRA clarifies its stance on Ivermectin
03 February 2021 There is an erroneous notion that SAHPRA “buckled under pressure” as a consequence of the court action brought by, amongst others the Afriforum regarding access to Ivermectin. SAHPRA wishes to state unequivocally that this is NOT the case. The court deliberations of 2 February...
27 Jan SAHPRA AUTHORISES COVISHIELD – AN ADENOVIRUS-VECTORED VACCINE FOR THE PREVENTION OF COVID-19
27 January 2021 In an effort to enable and support the country’s response in fighting the COVID-19 pandemic, SAHPRA has on 22 January 2021 granted a Section 21 authorisation to the Department of Health for COVISHIELD (a covid-19 vaccine manufactured by Serum Institute of India) for...
06 Jan SAHPRA OTC ONLINE DIRECTORY
06 January 2021 SAHPRA is pleased to announce the commencement of the build of an online directory for over the counter (OTC) SAHPRA approved medicines. This will include all Schedule 0, 1 and 2 registered OTC medicines. A launch date of May 2021 is anticipated. The domain...
22 Dec Extension of Post Importation Testing Exemptions
22 December 2020 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 30 April 2021 without further need of an application thereof. The initial approval date was extended to...
19 Dec Frequently Asked Questions: New Variant of SARS-CoV-2 in South Africa
19 December 2020 Health Minister Dr Zweli Mkhize on Friday announced that a variant of the SARS-COV-2 Virus (COVID-19) – currently termed the ‘501.V2 Variant’ – has been identified by genomics scientists in South Africa. Download PDF ...
10 Dec INFORMATION AND GUIDANCE ON IMMUNIZATION WITH THE NEW COVID-19 VACCINES
10 December 2020 What is a Covid-19 Vaccine? A COVID‑19 vaccine is any of several different vaccine technologies intended to provide immunity against coronavirus disease 2019 (COVID‑19).1 In general, vaccines contain weakened or inactive parts of a particular organism (antigen) that triggers an immune response within the...
04 Dec INFORMATION AND GUIDANCE ON APPLICATION FOR REGISTRATION OF CANDIDATE COVID-19 VACCINE
04 December 2020 Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, SARS- CoV-2. The rapid spread of this virus has resulted in the COVID-19 pandemic that has led to a dramatic loss of human life worldwide and presents an unprecedented challenge...
19 Nov BACKLOG CLEARANCE NEWSLETTER COMMUNICATION
19 November 2020 The Backlog Clearance Team has been made aware of a miscommunication in our Newsletter dated August 2020 and we would like to clarify the matter. It relates to the submission of Type I & II variation applications and states that Type I variations...
03 Nov HEALTH PRODUCT APPLICATION STATUS CHECKER
SAHPRA has implemented an application status checker. This new tool is listed under “Online Services” on the SAHPRA website. Accessing this tool will enable an applicant to check the status of their new health product(s) application. Please note that this tool is for Business-As-Usual applications only –...