Changes to OTC cannabis sales just around the corner
The Therapeutic Goods Administration (TGA) will shortly bring down its final decision regarding a major regulatory change in the distribution of cannabidiol (CBD) products in Australia.
The final decision is expected to be delivered in late December 2020, following on from the interim decision made in September.
The changes recommend that CBD products be down scheduled from schedule 4 and classified as schedule 3 medicines in Australia, which would allow Australian consumers to purchase CBD products over-the-counter (OTC) through pharmacies without the requirement of a prescription.
It has been a slow but welcome move to get to this point. It wasn’t until 2016 that Australia legally recognised the difference between marijuana and hemp. Before that , cannabis products were classified as Schedule (S8) Drugs and were strictly regulated and deemed poisonous.
Following that, the TGA lifted the ban on hemp extracts.
With this new legislature, December’s changes will be welcome but strict.
CBD content must be at 98% or less, with the remaining 2% allowed to be any of the other 100+ phytocannabinoids found in hemp.
The TGA’s cautious approach is due to its belief that there are too few studies on each individual phytocannabinoid other than CBD and THC to deem these others safe or effective for medical treatment.
However, the decision regarding amendments to down schedule cannabidiol (CBD) products to schedule 3 medicine would allow Australian consumers to purchase CBD products following consultation with a pharmacist without the need for a prescription.
This is a major move forward.
Once the announcement is made official, a doctor when writing a prescription will be required to fill out a Special Access Scheme (SAS) – an official petition to the TGA to allow patients to access CBD oil under the Australian medical cannabis program.
At the moment, doctors can only prescribe approved items by the Australian Register of Therapeutic Goods (ARTG).
Creso Pharma ready to help make a difference
For Creso Pharma (ASX:CPH), the potential down scheduling of CBD products in Australia could unlock a major market for its CBD and hemp products.
It is estimated that the local market is currently at over $200M per annum and growing.
CPH develops cannabis and hemp derived therapeutic, nutraceutical, and life style products with wide patient and consumer reach for human and animal health.
It uses GMP (Good Manufacturing Practice) development and manufacturing standards for its products as a reference of quality excellence with initial product registrations in Switzerland. It also has worldwide rights for a number of unique and proprietary innovative delivery technologies which enhance the bioavailability and absorption of cannabinoids.
“The potential down scheduling of CBD is a major development for the broader market and provides Creso Pharma with a number of opportunities and potential new sales channels,” Non-Executive Chairman Adam Blumenthal said.
“Australia has always been considered an important market in our growth strategy. Ahead of the TGA’s final decision, the Board and management have been exploring initiatives which will allow us to capture a large market share in Australia and unlock value for our shareholders.
“The Company remains well capitalised and looks forward to providing ongoing updates on progress.”
CPH already has products available on the Australianb market.
Its cannaQIX® 50 is currently being sold in Australia as a medicinal cannabis product under the ‘LozaCan’ brand via distribution partner ‘Burleigh Heads Cannabis’ (BHC).
Creso has also developed a wide range of CBD and hemp-oil products under the cannaQIX® brand, using its proprietary and innovative delivery technology which it expects to sell in Australia following any favourable decision.
The cannaQIX® range is manufactured under Good Manufacturing Practice standards and provides consumers with a standardised formulation and precise dosage measurement.