Posted 28 August 2017
The Finalised Medicines Regulations have been published at last: http://www.gov.za/sites/www.gov.za/files/41064_gon859.pdf
Regulation 42(5)(c)(ii)(cc) requires that advertisements for unregistered complementary medicines include the disclaimer: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.”
It also includes regulations governing Complementary medicines, and “Health Supplements“
“complementary medicine” means any substance or mixture of substances that –
(a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority;
(b) is used or purporting to be suitable for use or manufactured or sold for use –
(i) in maintaining, complementing or assisting the physical or mental state; or
(ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or
mental state of a human being or animal; and is used-
- as a health supplement; or
- in accordance with those disciplines as determined by the Authority;
“health supplement” means any substance, extract or mixture of substances as determined by the Authority, sold in dosage forms used or purported for use in restoring, correcting or modifying any physical or mental state by-
(a) complementing health;
(b) supplementing the diet; or
(c) a nutritional effect,
34. Complementary Medicines: Health Supplements
34.1 Amino acids
34.2 Aminosaccharides
34.3 Animal Extracts, Products and Derivatives
34.4 Carotenoids
34.5 Enzymes
34.6 Fats, Oils and Fatty Acids
34.7 Minerals
34.8 Polyphenols (including Bioflavonoids)
34.9 Probiotics
34.10 Saccharides (including prebiotics)
34.11 Vitamins
34.12 Multiple substance formulation
34.13 Other
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