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’s growing commercial presence in Australia along with its targeted clinical program places the company in a unique position to take advantage of the proposed changes announced by the TGA.
"Further increase in product offering”
Co-founder and MD Roby Zamer said: “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 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.”
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 is expected to restrict a number of company’s ability to supply Schedule 3 products in Australia.
Clinical program to develop new CBD products
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.