Complementary Medicines

There are allied fields of Sport and Health Supplements and Cosmetics which have their own regulatory regimes. Sports, discipline-specific (such as Chinese and Ayurvedic) and Health Supplements are considered Complementary Medicines and are regulated as Category D Medicines under the Medicines and Related Substances (MRS) Act and the Regulations thereunder. In great contrast to other countries, South Africa regulates Foodstuffs and Medicines separately and the categorisation of a product as a medicine largely lies in its intended uses, claims attached and dosage forms. Cosmetics, on the other hand, have been largely unregulated. However, the published Cosmetic regulations which deal with manufacture, ingredients, labelling etc are changing this landscape drastically.

The recent changes made to the Schedules under the MRS Act with respect to cannabis is also something our attorneys have focused on as we have ensured that our attorneys have attended the various workshops and stakeholder meetings with the Department of Health and SAHPRA in this respect. Our firm can also assist with advice when it comes to the registration process of these complementary medicines under the MRS Act as we have access to in-house registered pharmacists.

In this complex field where law meets science, it is critical to work with a legal team where the lawyers are qualified both in the sciences as well as in law and are able to understand the complex problems which may arise and provide practical advice thereon.

Our senior partner, Mr Luterek, holds degrees in both Chemical Engineering and Law and is a registered Attorney, Patent Attorney, and Professional Engineer and has worked in Food R & D at the CSIR, as a senior process engineer at APV, before completing his law studies and becoming a partner of Hahn & Hahn attorneys. He is a Custodian Member of the South African Association for Food Science and Technology (SAAFoST) and sits on both the Executive Counsel of the FSI of the Consumer Goods Council of South Africa as well as serving on the Food Law Advisory Group of the Department of Health. He has made numerous submissions both to Parliament and to the various government departments on proposed amendments to the various Laws and the Regulations thereunder.