South Africa is a multi-million rand market for complementary and alternative medicines (CAMs), but they are not regulated by the Medicines and Related Substances Act 101 of 1965. However, proposed amendments to the General Regulations in terms of the Act may alter this situation radically, with CAMs becoming subject to regulation by the Medicine Control Council (MCC) of South Africa. The MCC has in turn published guidelines outlining the consequences and requirements that will face the manufacturers of CAMs, which can be summarised as follows.