On 01 October 2020, the Pretoria High Court delivered its judgment in the matter between the Alliance of Natural Health Products in South Africa (“ANHP”) v Minister of Health and SAHPRA.
In the application ANHP sought to review and have set aside certain aspects of the General Regulations in relation to the regulation of complementary medicines, including health supplements, on the basis that the Minister acted ultra vires when promulgating the Regulations.
The Court found that The General Regulations promulgated on 25 August 2017 under General Notice 859 in GG 41064 are unlawful, to the extent that they apply to complementary medicines and health supplements that are not medicines or scheduled substances as defined in section 1 of the Act.
The declaration of invalidity is suspended for a period of twelve (12) months to allow the Authority to an opportunity to correct the defect.
However, the Minister and SAHPRA have since filed an application for leave to appeal as it is their intention to appeal this judgment.
Since the Minister and SAHPRA are appealing the judgement, this means that the judgement is stayed, pending the outcome of the appeal.
Therefore, the General Regulations under GG 41064 relating to the regulation of complementary medicines remain in force.
DID YOU KNOW?
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products.
This includes clinical trials, complementary medicines, medical devices and in-vitro diagnostics (IVDs).
Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa.
SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).
SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of all who reside in South Africa: Safety, Efficacy and Quality are these three pillars that define the ethos of SAHPRA.
THIS UNALTERED INFO WAS SUPPLIED BY SAHPRA.