Finalised Medicines Regulations have been published

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