Medicinal cannabis products for sale in chemists from 2021
CANNABIS is finally going mainstream with news the Therapeutic Goods Association lowered the poisons standard to allow CBD products to be sold in pharmacies across the nation.
Althea Group Holdings Limited informed investors via the Australian Stock Exchange today announcing the regulatory change would allow CBD products to be sold over-the-counter from February 1.
"Australian medicinal cannabis company Althea Group Holdings Limited (ASX: AGH) ('Althea' or 'the Company') is delighted to announce that a major regulatory change has been confirmed in relation to the status of cannabidiol CBD in Australia," Althea Group announced.
Althea CEO Josh Fegan said the move by the Therapeutic Goods Association (TGA) was great news for the industry and customers.
"Althea applauds the final decision by the TGA to amend the current Poisons Standard to down schedule CBD to allow greater access through a new Schedule 3 entry 1," Mr Fegan said.
"The amendment will allow Australian patients to purchase CBD products upon consultation with a pharmacist, without the need for a prescription.
"Althea will now proceed with plans to register several CBD products for sale in Schedule 3, including the top selling Althea CBD100."
The move allows CBD products to be classified as a Schedule 3 poison, permitting sale once all requirements are met.
"We applaud the TGA's final decision in this matter and are glad to see the administration listened to industry following the interim decision, and subsequently decided to increase the maximum recommended daily dose acknowledging that this dose is consistent with the expected safety profile of a Schedule 3 medicine 2," Mr Fegan said.
"The final decision follows the company's announcement to shareholders that it had raised additional working capital, through an institutional placement, with a portion of those funds allocated towards the product development and registration of a range of CBD products for the potential Schedule 3 market in Australia.
"This decision provides confirmation of that marketplace and the company can now proceed with its plans to have over the counter Althea products available for Australian patients in 2021."
Mr Fegan commended the final decision, which included a modification to the dose specified in the interim decision, increasing from 60 mg/day, up to 150 mg/day.
Before they can be sold over-the-counter, CBD products would have to be included in the Australian Register of Therapeutic Drugs, permitting their sale as schedule 3 products.
Althea said it maintained robust drug master files for its medications and was confident in its ability to meet the ARTG requirements for Schedule 3 preparations.