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South African Health Products Regulatory Authority

22/11/24, 04:00

The Health Products Regulatory Authority says it is open to adjusting THC percentage restrictions in CBD products, provided such requests are properly motivated and evidence-based

Statement from SAHPRA 17 November 2022


The international control framework for the medical and scientific use of cannabis and cannabis-related substances is established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances, 1971, as well as relevant resolutions of United Nations Economic and Social Council and the Commission on Narcotic Drugs.

The Conventions are overseen by the International Narcotics Control Board (INCB) and provisions are enacted within domestic legislation and regulations permitting licenced activities and use of narcotic drugs 1 and psychotropic substances 2 for medical and scientific use.


The application of the provisions of international drug control treaties allows for appropriate monitoring by the INCB and Competent National Authorities who, in South Africa, is Sahpra. This is to ensure that accurate data on licenced activities (e.g. cultivation) and the production of controlled substances accurately reflect the national estimates and Assessments are reported to the INCB by Sahpra/Competent National Authorities.


The medical and scientific control framework control and reporting requirements among member states includes licensure of cultivation, manufacture, distribution, monitoring process in preventing diversion to illicit market, reporting, and ensuring compliance with the international conventions by member states.


Sahpra is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. Sahpra’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) and Sahpra reports to INCB on all controlled substances.


Therefore, Sahpra through its schedules, in line with the above-mentioned, regulates cannabinoids such Tetrahydrocannabinol (THC) and Cannabidiol (CBD) for medical and scientific purposes. These control measures are aligned to international requirements and reporting requirements as committed to by the Republic.


The manufacturing (includes cultivation) of scheduled substances requires a Section 22C(1)(b) licence, supported by Regulation 23 of the Medicines Act and the licence holder must comply with good practices as determined by the Authority.


In conclusion, anyone can submit a request for review of scheduling status and limits for any scheduled substance; this must be supported by relevant backing information (e.g. evidence-based) and the Minister of Health with Sahpra will review and provide the outcome.


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SAHPRA statement on THC% restrictions in CBD products

SAHPRA statement on THC% restrictions in CBD products

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