29 March 2021 The SABC placed an erroneous report that “SAHPRA has agreed to allow the use of Ivermectin for the treatment of COVID-19”. This is grossly untrue, misleading to the public and irresponsible and could have dire consequences. The position of SAHPRA remains steadfast. Ivermectin may...
25 March 2021 As the entire world ushered in 2020, no one had any idea how life, businesses, governments, and nations would be disrupted. The “normal” that we were so familiar with got eroded rapidly as the pandemic gripped society with deadly force. Health regulatory authorities were...
19 March 2021 SAHPRA has implemented a new and improved online submission portal for Section 21 applications (Category A Medicines). This has been in development over the past few months. The new submission portal will improve the communication timelines between SAHPRA and applicants. It also allows the...
19 March 2021 On 16 March 2021 SAHPRA registered Soolantra 10mg/g cream formulation, which contains ivermectin. The holder of the certificate of registration is Galderma South Africa. Soolantra Cream is indicated for the topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult...
16 March 2021 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine. Download PDF ...
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 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 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 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 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 ...
