On 23 May, 2019, the health minister published a notice in the Government Gazette that excluded certain preparations containing cannabidiol (CBD) from the operation of certain provisions of the Medicines and Related Substances Act No 101 of 1965 (Medicines Act). Business Day reports that this exemption provided that CBD-containing products could be sold in the market without full registration as a medicine if it contains a maximum dose of 20mg of CBD, with an accepted low risk claim, or health claim only referring to things such as general health enhancement, without any reference to specific diseases, health maintenance or relief of minor symptoms not related to a disease or disorder.
It also exempted preparations containing CBD, which consisted of processed products made from cannabis raw plant material and processed products, in which only the naturally occurring quantity of cannabinoids found in the source material are contained in the product, and which contain no more than 0.001% of tetrahydrocannabinol (THC) and not more than 0.0075% total CBD. This exemption was valid for 12 months and lapsed on 15 May, 2020.
However, Business Day says, on Friday, the health department published an update to the Schedules of Medicines in Government Gazette No 43347, notice number R586.
From this update, and with the inclusion of this information on CBD in schedule 4, the report says it would appear that the health minister and the SA Health Products Regulatory Authority have attempted to address the matter of control over what goes into the local market by including some information from the previous exemption in the actual schedules, providing a more concrete and long-term solution to the many questions surrounding this specific aspect of CBD.
[link url="https://www.businesslive.co.za/bd/opinion/2020-05-23-clarification-comes-on-cannabis-scheduling-in-the-medicines-act/"]Full Business Day report[/link]