CBD medicines available for over-the-counter sale from 2021

Jane Morgan Management

Investment Highlights:

  • Althea applauds the final decision by the Therapeutic Goods Administration (TGA) to amend
    the current Poisons Standard to down schedule cannabidiol (CBD) to allow greater access
    through a new Schedule 3 entry1
  • The amendment will allow Australian patients to purchase CBD products upon consultation
    with a pharmacist, without the need for a prescription
  • Althea will now proceed with plans to register several CBD products for sale in Schedule 3,
    including the top selling Althea CBD100
16 December 2020: Australian medicinal cannabis company Althea Group Holdings Limited
(ASX:AGH) (‘Althea’ or ‘the Company’) is delighted to announce that a major regulatory change has
been confirmed in relation to the status of cannabidiol (CBD) in Australia.
TGA confirms new Schedule 3 entry for CBD
The Therapeutic Goods Administration yesterday issued its final decision on proposed amendments
to the Poison Standard which, amongst other amendments, sees a new Schedule 3 entry created
for cannabidiol. The date of effect of the decision is 1 February 2021, bringing it forward from the
date of 1 June 2021 as proposed in the interim decision.
The amendment will allow CBD to be supplied for therapeutic use under a new Schedule 3
(Pharmacist Only Medicine) entry. This new, non-prescription cannabis channel would allow
Australian patientsto purchase CBD products over the counter upon consultation with a pharmacist,
without the need for a prescription.
Maximum recommended daily dose increased
The final decision included a modification to the dose specified in the interim decision, increasing
from 60 mg/day, up to 150 mg/day. The decision paves the way for Althea’s top selling full-spectrum
CBD product, Althea CBD100, to be made available under Schedule 3 (currently sold in Schedule 4 –
Prescription Only Medicine).
Althea CBD100, along with several other CBD preparations currently in development, would need
to be included in the Australian Register of Therapeutic Goods (ARTG) to be made available for sale
as Schedule 3 products. The Company maintains robust drug master files for its medications and is
confident in its ability to meet the ARTG requirements for Schedule 3 preparations.
Althea CEO, Josh Fegan said: “We applaud the TGA’s final decision in this matter and are glad to
see the administration listened to industry following the interim decision, and subsequently decided
to increase the maximum recommended daily dose acknowledging that this dose is consistent with
the expected safety profile of a Schedule 3 medicine2
The final decision follows the Company’s announcement to shareholders that it had raised
additional working capital, through an institutional placement, with a portion of those funds
allocated towards the product development and registration of a range of CBD products for the
potential Schedule 3 market in Australia. This decision provides confirmation of that marketplace
and the Company can now proceed with its plans to have over the counter Althea products available
for Australian patients in 2021.”
/Public Release.