Australia TGA to Allow Registration of Over-The-Counter Low Dose Cannabidiol

Australia Therapeutic Goods Administration (TGA) announced on 15 December 2020 a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

The decision will allow TGA approved low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults, 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.
There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.

Sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG. Applications are individually evaluated for safety, efficacy and quality.

Unapproved CBD medicines can continue to be accessed via the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme on prescription only. Any Australian registered medical practitioner can apply to the TGA for approval to access unapproved medicines through the SAS or AP scheme if they believe it is right for their patient.

More information can be found at:

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