South Africa: Selected cannabis preparations now excluded from certain provisions of the Medicines and Related Substances Act

with a maximum daily dosage of 20 mg of CBD with an accepted low risk claim

On 23 May 2019, the Department of Health published Government Notice No. 42477 wherein the then Minister of Health, Dr Aaron Motsoaledi, excluded certain preparations containing cannabidiol (CBD) from the operation of Section 22A(2) of the Medicines and Related Substances Control Act 101 of 1965 (the “Act”).

In terms of this notice, any preparation containing CBD:

  • with a maximum daily dosage of 20 mg of CBD with an accepted low risk claim, or health claim which only refers to general health enhancement, health maintenance, or the relief of minor symptoms (unrelated to a disease); or
  • consists of processed products made from raw plant material, where the cannabinoids in the product is naturally occurring, the total tetrahydrocannabinol (THC) content does not exceed 0,001 %, and the total CBD content does not exceed 0,0075 %;

is excluded from the operation of Section 22A(2) of the Act.

Section 22A(2) of the Act determines that the Minister of Health can declare certain products to be scheduled medicines.

What this means is that any product which contains a daily CBD dose of not more than 20 mg and bears a low risk health claim; or which consists of the processed product of a raw cannabis plant wherein the levels of CBD and THC are very low, is not a scheduled medicine.

This renders these products legal to manufacture, sell, purchase, possess, and consume.

Examples of such products, which are already available on the market, include certain cannabis oils for human and animal use in relation to symptomatic support during the treatment of certain ailments; soaps, lotions, shampoos, ointments and other toiletries for human and animal use; as well as sweets and mints containing CBD marketed as nutritional support, amongst others.

This latest Notice has provided some much needed clarity in a specific section of the rapidly growing cannabis industry.

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