A major regulatory change has occurred in Australia, with the Therapeutic Goods Administration (TGA) altering the status of cannabidiol (CBD) in Australia. The TGA has moved CBD from a Schedule 4 to Schedule 3 (Pharmacist Only Medicine), which means you will now be able to access it for therapeutic use.
According to Medianet, this amendment will allow patients to purchase CBD products over the counter upon consultation with a pharmacist, but without the need for a prescription. This decision has also included a change to the recommended dosage, increasing it from 60mg per day to 150mg per day.
This change will come into effect on February 1, 2021, which is significantly sooner than the original proposal date of June 1. This amendment will allow medicinal cannabis company, Althea, to register several of its CBD products for sale in Schedule 3, including its top-selling Althea CBD100, which is currently considered a prescription-only medicine.
“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 medicine2,” said Aletha CEO, Josh Fegan.
“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.”
Original — September 10, 2020:
CBD products could be available over the counter by as early as next year thanks to a recent proposal by the Therapeutic Goods Administration. The industry body has announced plans to change the Poisons Standard for cannabidiol (CBD), which according to Medianet, would make it much more accessible.
This proposed amendment from the TGA would change CBD from Schedule 4 to Schedule 3 (Pharmacist Only Medicine). This means you would be able to purchase CBD products over the counter upon consultation with a pharmacist, without the need for a prescription.
Medicinal cannabis company Althea engaged with the TGA over this proposed change to the Poisons Standard as it would bring patient access into closer alignment with comparable international jurisdictions and improve access to CBD products for therapeutic use — without needing to see a GP.
“We applaud the TGA’s interim decision in this matter and see it as one of the biggest developments in our industry to date,” said Althea CEO, Josh Fegan. “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.”
According to the TGA, there will be a number of conditions when purchasing CBD products over the counter. For example, you won’t be able to buy more than 30 days worth of supply and all products will need to be taken orally.
A final decision on this proposed change is expected to come in November. Stay tuned!