- MGC Pharma (MXC) is getting ready for over-the-counter sales of low-dose CBD medicines ahead of regulatory changes mid-next year
- The Australian Therapeutic Goods Administration (TGA) plans to down-grade the medicines from Schedule 4 to Schedule 3 in June 2021
- Any medicine which will fall under the new Schedule 3 regulations will require registration on the Australian Register of Therapeutic Goods (ARTG)
- MGC has launched a clinical program to develop new Schedule 3 products under the Good Manufacturing Practice-certified (GMP) Mercury Pharma line
- ARTG registration requires GMP certification, meaning MGC essentially has a foot in the door when it comes to getting its medicines registered
- At Monday’s close, MGC Pharmaceuticals was trading 8.7 per cent higher at 2.5 cents
MGC Pharma (MXC) is getting ready for over-the-counter sales of low-dose CBD medicines ahead of regulatory changes mid-next year.
The Australian Therapeutic Goods Administration (TGA) plans to down-grade the medicines from Schedule 4 to Schedule 3 in June 2021.
Ready to go
The proposed scheduling change stands to benefit MGC, as the change aligns with the company’s goal of making medicinal cannabinoid products more accessible and affordable to patients.
Being able to supply low-dose CBD products over-the-counter at pharmacies without prescription is right up MGC’s alley, strategically-speaking.
The company recently made moves to acquire Medicinal Cannabis Clinics — an Australia-wide network of doctors and pharmacies providing access to medicinal cannabis products. The acquisition will be completed in the next month or so.
The company also recently launched its Mercury Pharma product line, which already has European Union Good Manufacturing Practice (GMP) certification.
MGC has launched a clinical program to develop new CBD products under the Mercury Pharma monicker which meet the proposed Schedule 3 requirements.
If successful, MGC could be one of the first companies to see Schedule 3 CBD products on pharmacy shelves when the proposed changes come into effect.
Market ready
MGC also has one other advantage over some competitors in that it already has EU GMP certification for a number of products.
Any medicine which will fall under the new Schedule 3 regulations will require registration on the Australian Register of Therapeutic Goods (ARTG).
ARTG registration requires GMP certification, meaning MGC essentially has a foot in the door when it comes to getting its medicines registered.
MGC Pharma co-founder and Managing Director Roby Zomer says the re-scheduling of low-dose CBD medicines will be a boon for the company.
“We are one of the market leaders in Australia for CBD products and 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,” Roby said.
If the necessary approvals fall into place, there could be high times ahead for MGC.
At Monday’s close, MGC Pharmaceuticals was trading 8.7 per cent higher at 2.5 cents.