According to the South African Health Products Regulatory Authority (SAHPRA), in Government Notice No. 586, Government Gazette No. 43347, issued on 22 May 2020, the Minister of Health has amended the scheduling of cannabidiol (CBD). Previous entries for cannabis, dronabinol, and tetrahydrocannabinol in Schedule 7 have been deleted.
CBD is listed in Schedule 4, except in:
· complementary medicines containing no more than 600mg CBD per sales pack, providing a maximum daily dose of 20mg of CBD, and making a general health enhancement, health maintenance or relief of minor symptoms (i.e. low-risk claim)
· processed products made from cannabis raw plant material intended for ingestion containing 0.0075% or less of cannabidiol where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.
Good news for CBD industry
The Health Products Association of Southern Africa (HPA) submitted a comprehensive down-scheduling application to SAHPRA on 24 April 2020 requesting hemp and CBD substances be added to the current annexures and health supplement lists for Category D Complementary Medicine and Health Supplements, as per the Medicines and Related Substance Act 1965 (Act 101 of 1966).
Since the application, CBD oil has been reviewed and is now officially a Category D, SO complementary medicine with relevant low-risk claims. Daily dose and other restrictions are specified in the schedules. This latest development provides some much-needed clarity and good news for CBD trade, customers, cannabis growers, and hemp farmers.
Scheduling changes and implications
The changes to the schedules have several implications. Firstly, the exclusion of certain CBD-containing products from Schedule 4 has been confirmed, but with important differences from the 2019 exclusion notice. When included as or part of a complementary medicine (Category D), not only are daily dose limits stipulated, but also maximum pack sizes.
Secondly, cannabis as a plant is removed from Schedule 7. Instead, the psycho-active ingredient tetrahydrocannabinol (THC) is listed in Schedule 6, with specific exemptions made for industrial application of low-THC cannabis.
According to SAHPRA, to date no CBD- or THC-containing medicines have been registered by the authority. Access to cannabis-related products for medicinal purposes remains subject to the requirements of the Medicines and Related Substances Act, the Regulations and Schedules issued in terms of the Act, and the guidelines issued by the authority.