Milestones in the Medical Cannabis Program
- A legal framework for the cultivation and processing of cannabis as an ingredient in registered medicines was approved in 2017. When local production is up and running, more regulations will be needed to facilitate access.
Key Laws and Regulations
- Medicines and Related Substances Act of 1965
- Cultivation of Cannabis and Manufacture of Cannabis-related Pharmaceutical Products for Medical and Research Purposes regulations, 2017
- The South African Health Products Regulatory Authority has received 21 applications for the cultivation of medical cannabis, one of which was later withdrawn.
- No companies had applied for permission to manufacture medical products containing cannabis as of June.
Medical Cannabis Products Available in the Market
- No medical marijuana products have been registered in the country, so the only way to acquire legal MMJ has been to import it.
North American Companies in the Market
- Ontario-based Canopy Growth has a medical cannabis subsidiary, Spectrum Therapeutics.
- Ontario-based Aphria has a joint venture with CannInvest Africa.
- Alberta-based Aurora Cannabis has a supply agreement with Akula Trading.
- Though medical cannabis is legal, business opportunities are extremely limited because of accessibility and regulatory hurdles.
- Eventually, however, opportunities will exist in cultivation. A legal framework for the cultivation and processing of cannabis as an ingredient in registered medicines was approved in 2017. But no company has been approved to manufacture medical products containing cannabis, such as oil extracts.
- South Africa recently carved out a federally approved market for nonprescription CBD, the first country on the continent to do so.
- The chief regulator is the South African Health Products Regulatory Authority.
- Licenses cover cultivation (for medical purposes); no license is needed for CBD products.
- Business opportunities include cultivation and the importation of medical cannabis as well as over-the-counter CBD products.
- All cannabis-containing products in South Africa—including CBD and high-THC goods—are subject to the Medicines and Related Substances Act of 1965. Medicines containing either, or both, cannabinoids require a prescription. South Africa recently amended the law to exclude certain CBD preparations from the Act, essentially removing legal barriers to commercializing those preparations. The legal exemption is valid only for one year.
- South Africa’s health minister amended the Medicines and Related Substances Act of 1965 to remove certain cannabidiol preparations for nonserious health claims on the recommendation of South African Health Products Regulatory Authority (SAHPRA). The rule change pertains to preparations that contain a maximum daily dose of 20 milligrams of CBD.