TGA announces final CBD down-scheduling


16 Dec 2020

Registered CBD products to be dispensed over-the-counter by pharmacists without the need for a prescription

Little Green Pharma welcomes the TGA’s final decision to both down-schedule certain medicinal cannabidiol (CBD) products from Schedule 4 to Schedule 3 (Pharmacist Only Medicine) as well as increase the maximum daily dosage to 150mg/day.

The decision will mean registered medicinal CBD products can be dispensed over-the-counter by pharmacists without the need for a prescription. The change in scheduling applies to CBD products with a maximum recommended daily dose of 150mg in packs containing 30 days or less supply, and where CBD comprises at least 98% of the total cannabinoid content in the preparation. Other CBD products will continue to be scheduled as Schedule 4.

Commenting on the TGA’s final scheduling decision, LGP Managing Director Fleta Solomon said: “This final scheduling decision demonstrates both the TGA’s commitment to patient safety and product quality as well as its appreciation of prescriber and patient needs. We wish to congratulate the TGA on its decision and look forward to the significant benefits it will bring to both Australian patients and prescribers and the Australian medicinal cannabis industry as a whole.”

The final decision change reflected additional safety information, public submissions, and the updated advice of the Joint Committee of the
Advisory Committees for Medicine Scheduling and Chemicals Scheduling. In addition to increasing the maximum daily dosage, the TGA also brought forward the implementation date from 1 June 2021, to 1 February 2021.

Critically, the decision to increase the maximum daily dose to 150mg will likely give Australian medicinal cannabis manufacturers the
confidence necessary to progress Australian Register of Therapeutic Goods (“ARTG”) CBD medicine registrations.

Previously, the interim low-dose scheduling decision had provoked industry concerns over the viability of demonstrating
the rigorous efficacy data required for registration. ARTG registration requires sponsors to undertake time-consuming and expensive clinical trials and product registration activities to demonstrate the medicine’s safety, quality and efficacy for the relevant registered indication, and with this revised decision it is anticipated sponsors will be far more confident progressing ARTG registrations at this higher dosing level.

LGP commends the final decision as a nuanced and careful scheduling decision by the TGA that has resulted in a very welcome outcome for
Australian patients. LGP anticipates the decision will drive registration applications across a range of eligible CBD conditions and will serve to only further increase the accessibility and affordability of medicinal cannabis for Australian prescribers and patients.

In the meantime, the Company will continue to assess its registration options for an eligible CBD product, including a formulation of its current CBD medicine.

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