The Australian Government's recent down-scheduling of CBD could bode very favorably for MGC Pharma, who is one of the current market leaders of CBD products in Australia.
MGC Pharmaceuticals Ltd (ASX: MXC), a European based biopharma company specializing in the production and development of phytocannabinoid-derived medicines, welcomes the proposed changes by the TGA to down-schedule certain low-dose CBD products in Australia to Schedule 3 status.
The proposed changes would allow specific low-dose medicinal CBD products to be dispensed over-the-counter by pharmacists to patients without a prescription. This move by the TGA significantly improves patient accessibility to medicinal CBD products while at the same time reducing the costs and time involved for patients to acquire them.
MGC Pharma is uniquely positioned to benefit from this as one of the current market leaders of CBD products in Australia, having recently imported the first shipment of the entire EU-GMP certified Mercury Pharma product line, which significantly expands the current range of medicines available in Australia for the Company.
This, combined with the upcoming completion of the Medicinal Cannabis Clinics acquisition (refer to ASX release 20 July 2020), greatly enhances MXC's distribution capabilities of its own CBD based products into the Australian market and patients. The Company's growing commercial presence in Australia along with its targeted clinical program, places MXC in a unique position to take advantage of the proposed changes announced by the TGA.
Eligible CBD products under Schedule 3 are still required to be registered on the Australian Register of Therapeutic Goods (ARTG), which requires companies to comply with strict Good Manufacturing Practices (GMP).
The GMP certification and ARTG registration are expected to restrict a number of companies' ability to supply Schedule 3 products in Australia. Figure 1 – MXC's Mercury Pharma Product: MP100 2 – 2 MGC Pharma has launched a clinical program to develop new CBD products under its Mercury Pharma line that meet the proposed Schedule 3 requirements, with the aim of being one of the first companies to see Schedule 3 CBD products on pharmacy shelves when the proposed changes come into effect in June 2021.
While meeting the regulatory requirements of Schedule 3 may be difficult for a number of operators, MGC Pharma welcomes the proposed changes from the TGA as they align with the Company's strategy to make medicinal cannabinoid products more accessible and affordable to patients, while at the same time maintaining the highest levels of product quality.
Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "We are very pleased to see the proposed down-scheduling changes from the TGA."
We are one of the market leaders in Australia for CBD products. Roby Zomer, Co-founder and Managing Director of MGC Pharma
Mr. Zomer went on to say that "these changes provide MGC Pharma with the ability to further increase our product offering and market penetration, while at the same time improving accessibility and affordability of high-quality CBD products for patients."
To learn more about MGC Pharma, visit the company HQ here.
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