Medicines and Related Substances Act Schedules on cannabis under the spotlight

medicines
19 Mar 2024

Work on finalising amendments to Medicines and Related Substances Act Schedules on cannabis will be undertaken once all submissions are received.

The South African Health Products Regulatory Authority (SAHPRA) confirmed this in a briefing to the portfolio committee on small business development on cannabis.

The health department published the proposed amendments for comment in Government Gazette 50001 in January 2024.

The proposed amendments seek to add reference to tetrahydrocannabinol in Schedule 6 except in raw cannabis plant material cultivated and possessed in accordance with a permit issued in terms of the Plant Improvement Act of 2018 and processed products manufactured from such material, intended for agricultural or industrial purposes including the manufacture of consumer items or products which have no pharmacological action or medicinal purpose; or when raw cannabis plant material is cultivated, possessed, and consumed by an adult, in private for personal consumption.

Reference to processed products made from cannabis containing 0,001 percent or less of tetrahydrocannabinol is to be removed from the Schedule.

SAHPRA regulates THC for medicinal purposes including cannabis plant material that exceeds the 0.2% THC limit while the agriculture, land reform and rural development department regulates low THC cannabis (less than 0.2% THC) for industrial purposes.

According to SAHPRA, the proposed amendments will enable the agriculture, land reform and rural development department to regulate the cultivation of all cannabis.

The limit for THC will be determined by the agriculture, land reform and rural development minister while SAHPRA will be tasked with oversight over cannabis cultivated for medicinal purposes only (including cultivation for the purposes of APIs).

SAHPRA highlighted that the proposed amendments are subject to justice and constitutional development legislation “overcoming cannabis in the Drugs and Drugs Trafficking Act schedule”.

SAHPRA also informed the committee that engagement with “stakeholders identified in the contingencies to ensure implementation of items identified” will also take place.

In terms of support, SAHPRA pointed out that it implemented a licence application status letter for medical cannabis licence applicants and provides leniency in terms of time for applicants to meet requirements.

Challenges in the medicinal cannabis space include diversion of product into the illicit market; applicants meeting requirements for medicinal cannabis; and registration of medicines containing THC and CBD.

SAHPRA also informed the committee that South African licence holders have and still are exporting bulk medicinal cannabis legally to importing countries.

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(This article is provided for informational purposes only and not for the purpose of providing legal advice. For more information on the topic, please contact the author/s or the relevant provider.)
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