Market Sensitive Announcement
ASX 16/11/2020
CGB WELCOMES TGA FINAL DECISION ON CBD PRODUCTS
Cann Global Limited (ASX:CGB) (Cann Global or the Company) is pleased to announce that the Therapeutic Goods Administration (TGA) has released its final decision yesterday on proposed amendments to the Poisons Standard.
The TGA has confirmed that it will down schedule cannabidiol (CBD) preparations from Schedule 4 (Prescription medicine) to Schedule 3 (Pharmacist Only Medicine).
In the final decision, the TGA has also increased the maximum daily dosage to 150 mg/day, up from 60 mg/day as proposed in the interim decision.
As noted in the statement from the TGA: “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 decision also outlines additional limits on dosage form and packaging requirements, including
pack size and child resistant closures.”
This decision from the TGA to down schedule CBD products follows the recent landmark decision made on 2 December by the United Nations Commission on Narcotic Drugs (CND) to reclassify cannabis as a Schedule I substance, the least restrictive drug classification.
Cann Global welcomes the TGA’s decision.
Through its joint venture with Canntab Therapeutics (Canntab), CGB has an import permit for two Canntab CBD hard pill products for which this change is expected to apply.
Cann Global is working with
a regulatory consultant to prepare its application to register both products on the ARTG in the coming months.
There are currently no TGA approved products on the
ARTG that meet the Schedule 3 criteria.
Canntab is an industry leader in solid oral dose formulations of cannabis in exacting doses.
The hard pill cannabinoid formulations provide doctors and patients with a discreet, uniform dosage, medical grade solution.
Whilst the joint venture has secured an import permit to Australia, Canntab are in the process of securing their Canadian export licence which is expected to be received imminently.
Canntab CBD pills are
expected to be available in Australia during the first quarter of 2021.