Complementary Medicines – Health Supplements Quality, Safety, Efficacy

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.


7 comments to Complementary Medicines – Health Supplements Quality, Safety, Efficacy

  • Lulekwa

    I’m developing a supplement range with a US based company ,I’d like to know will the new regulation effect the formulation of these new products.

    Please help.

    • Harris

      The answer is yes. You will see all the information you need on this blog. But your question suggests that you need some assistance and therefore I suggest you contact the Medicines Control Council for extra details.

  • Lulekwa

    @Harris, Thanks Harris , I indeed do..I do wanna waiste time and money on a product that will be illegal for me to market and sell in South Africa, but this website has helped a lot , but I think it would help to have the Medical Council hold my hand through this one.

  • Bernadine


    We are a small company wanting to formulate a food supplement (don’t want something that has to go through all the clinical trials, checks and end up needing to be registered at MCC). These costs are just to much for the size of our business. We also cant afford to pay a business 1000 to tell us yes your product formula is food or no it is complementary. Do you perhaps know where we can get a list off the internet for regulations of food supplements and ingredients qualifying as food and dosages allowed to consume per day in order to keep it as food supplement?

    Thank you very much.

    • Pieter

      Hi Bernadine, what did you end up doing? I am in the same boat and need to know whether my vitamins/minerals range would need to be submitted for CAM registration, if all ingredients fall within the permitted levels for a health supplement. Is there any way this range can be exempt from registration?

  • makgo

    how do I check if a product is registered and safe to use

    • Harris

      You could contact the MCC and ask them if the product is registered. Usually it is also printed on the packaging, but the best is to ask the MCC

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