ASX-listed cannabis stocks are on a high today after the Therapeutic Goods Administration (TGA) paved the way for over the counter cannabidiol (CBD) sales without a prescription at pharmacies.
The TGA has made an interim decision to amend the Poisons Standard to down-schedule medicinal cannabis to a Schedule 3 product in oral, oral mucosal and sublingual formulations for therapeutic use.
CBD products would need to include warning statements and safety directions, and meet the following criteria:
- the cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer;
- the maximum recommended daily dose is 60 mg or less of cannabidiol;
- in packs containing not more than 30 days' supply;
- cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation;
- any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2 per cent or less of the total cannabinoid content of the preparation;
- for adults aged 18 years and over; and
- packed in blister or strip packaging or in a container fitted with a child-resistant closure.
The TGA will be receiving submissions as part of its consultation process on this and other Poisons Standard matters until 12 October.
A public notice of final decisions is expected on 25 November, with amendments to be effective as of 1 February.
Medicinal cannabis companies saw their shares rise significantly today, including Bod Australia (+22.5 per cent), Elixinol Global (+9.7 per cent), Althea (+9 per cent), THC Global (+8.5 per cent), Cann Group (+7 per cent), Medlab Clinical (+7 per cent), Zelira Therapeutics (+3.5 per cent), IDT Australia (+2.86 per cent) and Little Green Pharma (+1.9 per cent).
Althea CEO Josh Fegan has applauded the TGA's interim decision, describing it as as one of the biggest developments in the industry to date.
"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," he says.
"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."
Business News Australia
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