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South Africa: Proposed amendments to the Medicines Act General Regulations

21 April 2023
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On 24 March 2023, the Minister of Health published draft proposed amendments to the General Regulations to the Medicines Act, 1965 (Proposed Amendments), a copy of which is available here. The Proposed Amendments relate primarily to the substitution of the existing definition of ‘Complementary Medicine’ with a simple reference to a ‘Category D medicine’. The following additional definitions have also been proposed: 

  • ‘discipline-specific medicine’ which means a Category D medicine contemplated in regulation 9(2)(a) [detailed below] that is intended for use in humans;
  • ‘health supplement’ means a Category D medicine contemplated in regulation 9(2)(b) [detailed below] that is intended for use in humans;
  • ‘veterinary discipline-specific medicine’ means a Category D medicine contemplated in regulation 9(2)(a) that is intended for use in animals; and
  • ‘veterinary health supplement’ means a Category D medicine contemplated in regulation 9(2)(b) that is intended for use in animals.

In terms of the regulation 9(2)(a), Category D Medicines are further classified into discipline-specific medicines for humans (including Aromatherapy, Homeopathy, Phytotherapy,  Traditional Chinese Medicine, Unani Medicine, Western Herbal Medicine, Combination Product and other Herbal) and veterinary discipline-specific medicines for animals (including Aromatherapy, Homeopathy, Phytotherapy,  Traditional Chinese Medicine, Unani Medicine,  Western Herbal Medicine, Combination Product and other Herbal).

In terms of the regulation 9(2)(b), Category D Medicines are further classified into health Supplements for humans (including Amino Acids, Aminosaccharides, Animal Extracts, Products and Derivatives, Carotenoids, Enzymes, Fats, Oils and Fatty Acids, Minerals, Polyphenols (including Bioflavonoids), Probiotics, Saccharides (including prebiotics), Vitamins and Multiple substance formulation) and veterinary health supplements for animals (including Amino acids, Aminosaccharides, Animal Extracts, Products and Derivatives, Carotenoids, Enzymes, Fats, Oils and Fatty Acids, Minerals, Polyphenols (including Bioflavonoids), Probiotics, Saccharides (including prebiotics), Vitamins and Multiple substance formulation). All of these exclude medicines or substances listed as Schedule 1 or higher in the Medicines Act.

Aside from changes to the definitions, the existing substantive provisions governing Category D medicines remain largely the same save that in relation to the labelling of a Category D veterinary medicine one now needs to specify:

  • the discipline of the medicine, or alternatively, that it is a veterinary health supplement; and
  • that it is a ‘Complementary Medicine’.