Press Release from the acting CEO - SAHPRA
Download press release here.
Cannabidiol (CBD) is one of the naturally occurring non-psychoactive cannabinoids found in the Cannabis plant (including Cannabis sativa L.).
Prior to 23 May 2019, CBD was classified in terms of the Medicines and Related Substances Act 101 of 1995 (Medicines Act), as either Schedule 4 (when intended for therapeutic use), or Schedule 7 (when not for therapeutic use).
Medicines and substances which fall into Schedule 4 are only available on a doctor’s prescription, while those classified in Schedule 7 are not readily available to members of the general public.
On the recommendation of SAHPRA, the Minister removed CBD from Schedule 7, classifying all CBD containing products as Schedule 4 substances. (See the Government Notice No: R755. Government Gazette No: 42477).
SAHPRA will closely monitor the compliance with requirements relating to labelling, advertising, manufacture, dosing, purported benefits and sale of CBD containing products. Based on this monitoring, the Authority will consider any need to call up any CBD products as medicines for registration in terms of section 14(2) of the Medicines act, as may be required.
Any products found not to be in compliance with the excursion notice must be immediately withdrawn from the market or be reported to SAHPRA for investigation.
It is also important to note that the exclusion notice is limited to a period of 12 months. During this time, stakeholders will be consulted regarding possible further amendment of the scheduling of CBD and related substances.
For any queries please do not hesitate to contact Mr. Molewa or Ms Daphney Fafudi from the Office of the CEO:
Regulatory Compliance unit by the email at Mogale.Molewa@sahpra.org.za or Mokgadi.firstname.lastname@example.org
Alternatively via telephone on 071 604 7751 or 066 3011 878