South Africa, Medicines And Related Substances Control Act

New draft regulations to the Medicines and Related Substances Control Act, 101 of 1965, 51: the new draft regulations were published on July 16th, 2004 and have far reaching implications as they introduce radical changes. Regulation 25 includes a definition for a class of medicine that has been added and a list of the medicines that fall within the definition. The list includes homeopathy medicines, nutraceuticals, vitamins and minerals, flower remedies, and other complementary medicines. These classes of medicines are then further divided into categories, including energy tonics and drinks, antioxidants, probiotics, bioflavonoids, etc, which will thus classify as medicines and will have to be treated as such in terms of advertising, distribution, marketing, etc according to a Code of Practice. The regulations also introduce a “health fraud” offence for anyone who does not comply with the terms of the regulations and the Code of Practice.