SAHPRA warns on cannabis-containing medicines

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South Africa‘s medicines regulator has warned consumers that all medical products containing cannabis on the local market are illegal, as none have been registered with the authorities, reports Business Day. The South African Health Products Regulatory Authority (SAHPRA) is quoted in the report as saying that the recent Constitutional Court ruling legalising the cultivation and possession of cannabis for personal use did not mean people could use it to manufacture and sell their own medicines.

The court handed down a judgment in September 2018 that declared existing legislation criminalising the use, possession and cultivation of cannabis unconstitutional. It is therefore no longer an offence for a person to use or be in possession of cannabis in private, or to cultivate the plant in a private place for their personal consumption. The medicines regulator said that there were a number of outlets and individuals selling cannabis-containing products, including oils, for medicinal use, in contravention of the Medicines and Related Substances Act.

According to the report, the Act says no one may sell medicines that are not registered with the regulator. “The cannabis-containing products and oils that are currently available in SA and which have not been registered or approved by SAHPRA are therefore illegal. Suppliers and users of such illegal products are exposing themselves and others to legal and health risks as the safety, efficacy and quality of these products cannot be assured,” it said.

The report says patients seeking cannabis-containing medicines were advised by the regulator to apply for an exemption to section 21 of the Medicines Act, which enables the importation of medicines that have been registered in other countries, such as Canada and the Netherlands. “To date, 56 such applications have been approved by Sahpra, based on motivation for use in specific patients by an authorised prescriber,” it said.

The report says the two key compounds of interest in cannabis are THC (delta-9-tetrahydrocannabinol), which has psycho-active properties, and cannabidiol. In 2017, the regulator eased some of the restrictions on medicinal cannabis, to make it easier for patients to access. It reclassified it from a tightly restricted schedule 7 product, to a permitted schedule 6 (containing THC) or schedule 4 product (without THC).

It also created the legal framework for legalising the cultivation of cannabis for medicinal use or research, in conjunction with the department of health and the department of agriculture, forestry & fisheries.

“Licensed domestic cultivation of cannabis for medicinal use is aimed at ensuring sufficient local supply for medical, scientific and clinical research purposes, and the implementation of control measures necessary to prevent diversion and misuse, as well as to ensure patient safety,” SAHPRA is quoted in the report as saying.

The regulator said it had received 21 licence applications for the cultivation of cannabis to date, one of which was subsequently withdrawn. A total of 16 applicants had been inspected so far, but none had yet made the grade.

The report says the regulator had not responded to request for comment at the time of publication.

Business Day report

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