07 May SAHPRA Statement on the ANHP Judgement
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Press Releases
03 May SAHPRA Comments on ACDP court matter on vaccines for minors
03 May 2022 Embargo: Immediate release Pretoria, 3 May 2022 - In October 2021, the African Christian Democratic Party (ACDP); Free the Children -Save the Nation NPC, Caring Healthcare Workers Coalition NPC, and the COVID Care Alliance NPC initiated court action against the Minister of Health and...
19 Apr SAHPRA Responds to the ANHP Judgement
20 April 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) notes the ruling by the Supreme Court of Appeal (SCA) in favour of the Alliance of Natural Health Products in South Africa (ANHP) on 11 April 2022. SAHPRA is studying this judgement and consulting...
08 Apr SAHPRA Responds to claims that hawkers are selling illicit medication in Cape Town
08 April 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) remains committed in protecting the public from the supply of counterfeit and substandard medicines. Following the media report by eNCA claiming that some hawkers in Cape Town were illegally selling medicines, SAHPRA worked...
11 Mar SAHPRA clarifies the risks and benefits of the Pfizer Comirnaty vaccine
11 March 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) has noted that a safety report in relation to the COVID-19 Pfizer Comirnaty vaccine directed to the United States Food and Drug Administration (FDA) has been distributed on various communication platforms in South...
08 Dec SAHPRA approval of second/booster dose of the COVID-19 vaccine Janssen
23 December 2021 Embargo: Immediate release The South African Health Products Regulatory Authority (SAHPRA) initially registered the COVID-19 Vaccine Janssen, with conditions on 30 March 2021, in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965). On 10 December 2021, SAHPRA received...
08 Dec SAHPRA approval of booster dosing with the Pfizer (Comirnaty®) COVID-19 vaccine
8 December 2021 Embargo: Immediate release The South African Health Products Authority (SAHPRA) initially approved the use of Pfizer’s Comirnaty® COVID-19 vaccine on 16 March 2021, in terms of section 21 of the Medicines and Related Substance Act (Act 101 of 1965). On 17 November 2021, SAHPRA received...
26 Nov SAHPRA and the Pfizer Booster (3rd dose) Vaccine
26 November 2021 Embargo: Immediate release SAHPRA has received an application for the Pfizer Comirnaty Booster/3rddose vaccine on 17 November 2021. This is for the homologous booster regimen, not a mix-and-match approach. SAHPRA will now commence with the assessment of data for the safety and efficacy of the third...
18 Oct Update on the SAHPRA review of the Sputnik V Vaccine
18 October 2021 SAHPRA has been engaged in a rolling review of the data for the Sputnik V COVID-19 vaccine since the initial application was submitted on 23 February 2021. This vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian...
10 Sep SAHPRA update on Section 21 authorisation for Pfizer Comirnaty Vaccine
10 September 2021 The South African Health Products Authority (SAHPRA) has approved the use of the Pfizer COMIRNATY Vaccine in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965 (The Medicines Act) to include individuals twelve years (12) years and older....