South Africa: homeopathy case clarifies ‘medicine’ definition


Kareema Shaik and Jenny Pienaar

South Africa: homeopathy case clarifies ‘medicine’ definition

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South Africa’s Supreme Court has declared regulations on complementary medicines invalid, explain Kareema Shaik and Jenny Pienaar of Adams & Adams.

In August 2017, South Africa’s Minister of Health, Aaron Motsoaledi, issued updated General Regulations (“the Regulations”) in terms of the Medicines and Related Substances Act 101 of 1965.

This introduced the category of “complementary medicines”, the definition of which included, inter alia, aromatherapy and homeopathy products and, under the sub-category of health supplements, vitamins, minerals and probiotics.

The regulations stipulated a number of requirements that complementary medicines would have to comply with, including labelling and advertising requirements. Given the wording of the regulations, producers of complementary medicines were also advised to obtain a licence from the South African Health Products Regulatory Authority (SAHPRA) to manufacture such products on the basis that complementary medicines qualify as, and fall within, the definition of a “medicine” as defined in the act.

Adams & Adams, homeotherapy, Supreme Court of Appeal, labelling, advertising, complementary medicine, SAHPRA