TGA allows OTC sales of Cannabidiol
The medical cannabis industry took a big step forward in Australia today with the announcement from the regulator. The Therapeutic Goods Administration or TGA has announced it will down-schedule cannabidiol (CBD) in low dose preparations from Schedule 4 (defined as prescription medications) to Schedule 3 available in pharmacies.
According to the site:
“The decision will allow low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription.
The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG).”
The maximum daily dose proposed was increased from 60 mg/day originally suggested to 150 mg/day after extensive consultation with key stakeholders.
It is now possible for sponsoring companies to apply for inclusion of CBD preparations on the ARTG. Applications will be independently evaluated for quality and safety. Further information is available in the Australian Regulatory Guidelines for OTC Medicines (ARGOM).
Significant growth in CBD market predicted
It is stated that the decision was made on the back of a safety review of CBD. The review indicated that, according to the latest evidence, low doses of CBD are unlikely to cause serious adverse side effects.
A senior medical officer at the TGA approved the decision that is likely to have significant implications for the CBD market that has been growing substantially around the world. Some analysists have suggested that the international cannabidiol market may surge in the coming years with a compound growth rate of 40%.
Over the counter sales of CBD in Australian pharmacies is the strongest indication yet that regulators are coming round to the idea that cannabis products and specifically full spectrum cannabinoids may be effective for a range of ailments and this is good news for Australian medical cannabis patients.
However specific products need approval, so it is likely to be sometime before we see products on the shelves. First movers are likely to reap the largest ROI in the long term based on recent history in the Australian market.