Cannabidiol products can be cleared for over the counter purchase under a proposed Therapeutic Goods Administration reclassification, opening a potential $200 million market section.
The proposed amendment is a provisional ruling to downgrade CBD against the Poisons Standard from Schedule 4 to Schedule 3, which would clear the way for Australians to buy products containing this substance, without a prescription, over the counter in pharmacies.
The recommendation applies to registered pure CBD products sold to adults in packets containing up to 1800 mg and with the counsel of pharmacists, like other OTCs medicines.
Smoking, vaping and topical use of CBD would remain banned under proposed reclassification. Recommendations by the TGA are usually adopted by the government and this one is the consequence of a long, two part review process. We applaud the TGA’s interim decision in this issue and consider it as one of the biggest developments in our industry at date, said medicinal cannabis firm Althea’s CEO Josh Fegan. The interim decision reflects a significant change in the attitudes of the community and the government towards medical cannabis since it was legalised in Australia in late 2016, that has seen it move from a fringe alternative towards an accepted mainstream option.
As an active advocate of patient access, Althea has closely monitored the proposed amendment since it began and has participated in the consultation process. We’re 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. Nevertheless, critics of the interim solution have expressed concern that products containing limited doses of CBD can be too weak to have a demonstrable clinical effect. This is a welcome move, but it is important to note that the effects of a low dose of CBD can be negligible for many patients, said CA Clinics Medical Advisory Board Member and addiction specialist.
Mark Hardy. Patients seeking treatment for chronic conditions that can benefit from medical cannabis might requires higher doses or other cannabinoids like THC and should therefore consult their GP prior to taking these products, even in small amounts. We believe low dose CBD will become the largest market in Australia for cannabis products, rapidly generating revenue in the hundreds of millions of dollars, added Southern Cannabis Holdings director Tim Drury. There’s a significant opportunity here for product companies to provide top quality, cost effective medicine to pharmacies.
Relevant Read: CBD Benefits Chart