Huge change to rules around medicinal cannabis
MEDICINAL cannabis could soon be available over the counter in a major regulatory change that has been proposed in Australia.
The change would down-schedule cannabidiol (CBD), making it available without a prescription.
The Therapeutic Goods Administration this week released a notice of interim decision to amend the Poisons Standard for CBD.
The proposed amendment to down-schedule CBD from Schedule 4 would allow CBD to be supplied for therapeutic use under a new Schedule 3 (Pharmacist Only Medicine) entry.
This new, nonprescription cannabis channel would allow Australian patients to purchase CBD products over the counter upon consultation with a pharmacist.
Josh Fegan, the chief executive of Australian medicinal cannabis company Althea, said they had engaged with the TGA throughout the consultation process and supported the down scheduling of CBD.
He said the proposed amendment would improve access to CBD products for therapeutic use.
"We applaud the TGA's interim decision in this matter and see it as one of the biggest developments in our industry to date," he said.
"The interim decision reflects the significant shift in community and government attitudes towards medicinal cannabis since it was legalised in Australia in late 2016, which has seen it move from a fringe alternative towards an accepted mainstream option.
"As a strong advocate for patient access, Althea has closely monitored the proposed amendment since it began and has participated in the consultation process.
"We are excited by the TGA's interim decision to down schedule CBD products and see this development as a big step forward for prescription cannabis products already available in Australia."
The TGA's interim decision places restrictions on the preparation and dose, dosage form, pack size, age and limiting supply to Australian registered products.
Other requirements include child-resistant closures unless the product is packed in blister or strip packaging, and limiting supply to medicines including CBD which are entered on the Australian Register of Therapeutic Goods.
A final decision is expected to be made in November.