Posted 24 November 2014
The MCC has proposed an additional category, ‘health supplement’, to be included in the definition of a complementary medicine. This category requires to comply with parameters that were to be furnished in a guideline, that would define the requirements for the claims for efficacy, quality, safety, etc. This has now been formally released. This document, released on the 20th November, is a draft released for comment by 26 February 2015.
“The purpose of this Guideline is to provide clear guidance with regard to the quality, safety and efficacy (QSE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa. The intent of this document is to ensure that the levels of evidence for QSE are rigorous enough to protect public health and maintain consumer confidence, while providing a clearly defined pathway to register health supplements.”
The document is available here.