Cannabis has received much attention over the past few years and with more countries entering the global cannabis market, international trading is fast becoming a reality.
In South Africa, three separate events have influenced the legality of cannabis since 2017: • a licensing framework was introduced for the domestic cultivation and manufacture of medicinal cannabis; • the Constitutional Court of South Africa de-criminalised the private use and cultivation of cannabis; • the Minister of Health rescheduled cannabidiol (CBD) and tetrahydrocannabinol (THC) in May 2020.
Currently in South Africa, cannabis cultivation licenses are issued to companies complying with the guidelines set out by the South African Health Products Regulatory Authority (SAHPRA) and the Good Agricultural and Collection Practices (GACP) standards. One of the qualifying criteria is proof of intent of an off-take agreement between the cultivator and a customer internationally. It is important to also note that the GACP licenses are only for medicinal cannabis cultivation as it is still illegal to trade in cannabis earmarked for the recreational market globally. The INCB is the United Nations independent control body for international drug conventions. In the context of cannabis, the 1961 Single Convention allows cannabis to be produced and administered for medical and research purposes under certain conditions. The required controls include that a government agency designates the area where cannabis can be cultivated, and licensed producers have the exclusive right to import, export, trade at wholesale and maintain supply. One of the largest challenges South African cannabis cultivators face once licensed by SAHPRA, is to find an international take-off contract. The European market is one of the largest accessible markets and in order to supply to it, the standard of cultivation and further processing needs to comply with its standards. Unfortunately, being licensed by SAHPRA in South Africa does not mean that Europe will accept this product as South African standards are not recognised in Europe. Importation of seeds at this stage is facilitated by the Department of Agriculture, Forestry and Fisheries. With regard to compliance of the MRSA (Medicines Act, 101 of 1965) and SAHPRA, all phytosanitary certificates and source of origin documents are required to validate and ensure that the product comes from a verified, registered and approved source. In order to obtain the required import permit, an applicant has to register with the above-mentioned department, and phytosanitary certificates must then be provided by a supplier who has a valid and registered seed company. Presently there is no local seed bank registered and some applicants import seeds, cultivate the mother plant and supply cuttings to other license holders.
In May 2020, the Minister of Health made updates to the schedules of THC and CBD; these are detailed in the Regulation Gazette No.11118 as per R.586 of the Medicines and Related Substances Act, Act 101 of 1965. This now allows for cannabis and cannabis related products to be sold in South Africa, opening the country for the importation of CBD products, with more appearing on the shelves of larger retailers. The allowed concentration of the CBD is 20mg per serving or 600mg per package; higher CBD concentrations than this, and THC products, are strictly on prescription only.
Gabriel Theron is the CEO and Chairperson of the Board of Directors of Cilo Cybin Pharmaceuticals, one of the licensed cannabis cultivators under GACP standards in South Africa and soon to be GMP accredited for the further processing and manufacturing of cannabis products. Cilo Cybin recently contracted with an international brand, named Aunt Zelda’s, as the global manufacturer and distributor. The founder of Aunt Zelda’s has been a key player in medical cannabis products and cannabis treatment globally.
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