Last updated: June 06, 2025
In South Africa, complementary medicines are governed by the Medicines and Related Substances Act (Act 101 of 1965) and the South African Medicines and Medical Devices Regulatory Authority (SAMMDRA) Act (Act 132 of 1998). General Regulations published and implemented as per Government Notice 859 in Government Gazette 41064 on 25 August 2017. This resulted in the inclusion of new sub-categories of Category D, including those traditional disciplines that are not indigenous to South Africa (discipline-specific medicines) but also the more modern supplement-type of medicines (health supplements).
General Regulations in 2013 were deleted by the General Regulations in 2017. A new timeline, which will be established by way of the publication of call-up notices in terms of section 14 of the Medicines and Related Substance Act, 1965 (Act 101 of 1965) (hereafter referred to as “the Medicines Act”)
In South Africa, the primary legislation governing complementary medicines is the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Specific regulations and guidelines are issued by the South African Health Products Regulatory Authority (SAHPRA) to implement this Act.
Category D Medicines (Complementary Medicines) has been established in the General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Medicines compliant with the prescribed definition for this category are included in Guidance on progression to regulatory compliance by way of the SAHPRA Guideline 7.02.
General Regulations (“the Regulations”) made in terms of the Medicines & Related Substances Act No. 101 of 1965 as amended (“the Medicines Act”). The amendments were published in the Government Gazette on 24 March 2023. The public has one month to comment on the regulations as of 24 March 2023.The amendments concern primarily the treatment of complementary medicines in the Regulations. Centrally, the definition of “complementary medicine” has been amended from its current rambling version into a definition that simply defines a complementary medicine as “a Category D medicine.”
In turn, a Category D medicine is to be defined as “medicines classified in sub-regulation [9(2)], intended for use in humans or animals which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine.”Regulation 9(2) as it is to be amended will refer to medicines “identified in class 33 of Annexure 1 and class 28 of Annexure 2” and “medicines identified in class 34 of Annexure 1 and class 29 of Annexure 2, excluding medicines or substances listed as Schedule 1 or higher in the Act.”
Therefore, the existing discipline-specific criteria, which are set out in classes 33 and 28, respectively, remain with only a shift in the textual relationship between the Regulations and the annexures to the Regulations. Class 33 of annexure 1 refers to various allied professions and class 28 of annexure 2 refers to complementary medicines used for veterinary purposes. Class 34 of annexure 1 refers to health supplements and class 29 of annexure 2 refers to supplements used for veterinary purposes.