TGA Approval Of Low Dose Cannabidiol, page-19

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Media Release9 September 2020

THC Global Supportive of TGA Interim Decision on S3 CBD Products

Key Points

• TGA Interim Decision released today 9 th Sept with respect to the downscheduling of cannabidiol
• THC Global provided a submission to the TGA on the interim decision todown schedule CBD medicines to a new Schedule 3 entry (pharmacy onlymedicines)
• THC Global is exceptionally well positioned for an expanding market in CBDmedicines
• Highly supportive of TGA’s proposed changes which will easier access to low-dose pharmaceutical-grade CBD medicines for Australian patients
• The Company’s Southport Manufacturing Facility will be capable of highvolume production of S3 medicines

THC Global Group Limited (ASX:THC) is pleased to see the TGA Interim Decisionreleased today with respect to the down scheduling of cannabidiol (CBD) medicinesto a new Schedule 3 (S3) entry allowing for access at pharmacies withoutprescription.

THC Global’s submission to the TGA has now been made public following theinterim decision. The Company’s submission recognised the priority of consumersafety in any down scheduling decision, and supported the increased availability ofnaturally sourced CBD medicines, noting its well-documented safety profile. TheCompany further opined on the presence of minor cannabinoids in the medicinesand appropriate package warnings, leveraging its extensive body of cannabismedicine research and knowledge.

As announced in May 2020, prior to the Joint ACMS/ACCS meeting which led to theinterim decision from the TGA, the Company is exceptionally well positioned for anexpanding market in CBD medicines. THC Global’s Southport facility is capable ofmanufacturing these medicines at significant scale to support Australian demandfollowing the implementation of this interim decision.

Chief Executive Officer, Jarrod White, commented: “We’re pleased to see the TGAtake this first step in reducing barriers for patients to access pharmaceutical gradeCBD medicines through the down scheduling of CBD medicines to Schedule 3. Inour submissions to the TGA on this issue, we have highlighted the need to ensurepatient safety and responsible access. With the Southport Facility, we are wellplaced to enter this market as a high volume high quality pharma GMPmanufacturer, ensuring accessibility and affordability of these medicines to patientsin need without sacrificing quality.