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Rescheduling of medicines and exclusions to certain provisions of the Medicines Act include a change to status of Cannabidiol

Fasken
Reading Time 2 minute read

The Schedules to the Medicines and Related Substances Act No 101 of 1965 (“Medicines Act”) in terms of Section 22A(2) was updated by the Minister of Health through publication in the Government Gazette on 23 May 2019.

Requirements relating to which persons have the authority to prescribe and supply medications within their specific scope of practice and subject to indication of use and to the conditions determined by the South African Health Products Regulatory Authority (SAHPRA), remain unchanged.

There has however been a change to the scheduling of cannabidiol (CBD) from Schedule 7 to Schedule 4.

The Minister also excluded certain preparations containing CBD from the operation of certain provisions of Section 22A(2) of the Medicines Act. These exclusions include preparations containing CBD that –

  1. Contain a maximum daily dose of 20mg of CBD with an accepted low risk claim or health claim which only refer to general health enhancement without any reference to specific diseases, health maintenance or relief of minor symptoms (not related to disease or disorder); or
  2. Consist of products made from cannabis raw plant material and processed products, where 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 cannabidiol (CBD).

The above exemption from the provisions of Section 22A(2) of the Medicines Act will be effective for a period of 12 months from May 15, 2019.