In brief - Over-the-counter access to CBD in Australia is one step closer following TGA's announcement
Main take-aways for industry participants
TGA has announced its interim decision to down schedule CBD to a Schedule 3 substance from 1 June 2021
Only medicines containing at least 98% CBD and entered on the Australian Register of Therapeutic Goods will be available over-the-counter
Sponsoring companies seeking to register medicines for domestic supply should consider their TGA applications now to avoid disappointment
After considering some 5,409 public submissions, Australia's Therapeutic Goods Administration (TGA) announced its interim decision to amend the current Poisons Standard to down schedule cannabidiol (CBD) as a Schedule 3 substance with effect from 1 June 2021. 80% of those public submissions supported the down scheduling of CBD in some form.
The interim decision would permit medicines containing at least 98% CBD and which are entered on the Australian Register of Therapeutic Goods (ARTG) to be provided by pharmacists to adults aged 18 years and over without the need for a prescription. The upshot being that only those medicines entered on the ARTG would be available over-the-counter following a successful implementation of the interim decision and that access to other CBD-based and infused products widely available in other jurisdictions remain a good way off in Australia.
At the time of writing, there are eight medicines entered on the ARTG containing CBD as an active ingredient, all categorised as export only medicines. There are currently no registered CBD products in Australia and unapproved CBD products are accessed via the Special Access Scheme.
Given the significant M&A and capital markets activity across the Australian and international cannabis industries in the last three years, we anticipate seeing the number of sponsors applying to register medicines for domestic supply significantly increase prior to the proposed changes taking effect.
In order for a medicine to be entered on the ARTG, the sponsoring company must lodge an online application with the TGA in accordance with the Australian Regulatory Guidelines for OTC Medicines (ARGOM). We recommend that parties consider the requirements of an application now to avoid disappointment come 1 June 2021.
The Joint Advisory Committee on Medicines and Chemicals Scheduling is due to meet again in November 2020 to further consider the TGA's interim decision.
This is commentary published by Colin Biggers & Paisley for general information purposes only. This should not be relied on as specific advice. You should seek your own legal and other advice for any question, or for any specific situation or proposal, before making any final decision. The content also is subject to change. A person listed may not be admitted as a lawyer in all States and Territories. © Colin Biggers & Paisley, Australia 2023.