Entoura Pushes for ARTG Registration in Response to CBD Down-Scheduling

However, the company has stated that we are "unlikely" to see its CBD products on the shelves until 2022 at the earliest.

The Melbourne-based cannabis company, Entoura Pty Ltd, announced this week that the Therapeutic Goods Administration's (TGA) recent decision to down-schedule low dose CBD has paved the way for the company to apply for ARTG registration for all three of its GMP-compliant products.

Under the TGA's ruling, individuals will soon be able to purchase CBD over the counter, with a limit of 150mg per day—which is a significant increase on the previously proposed maximum of 60mg—while the implementation date has been brought forward to February 2021.

The registration requirements for S3 medicines are detailed and Entoura is working towards ensuring we have all the required clinical data to support the submission, including information from our current clinical trial with Applied Cannabis Research. With the submission requirements and TGA review timelines, there are unlikely to be S3 product options available for Australian consumers until 2022.Entoura General Manager, Clare Barker

This means that all three of the company's CBD products should qualify for OTC sale, as they come in packets containing up to 4500mg of CBD—amounting to a 30 day supply at the recommended 150mg daily dosage limit—which should satisfy the TGA and ARTG's S3 dose and pack size criteria.

Entoura's three GMP-compliant products also come in oral, oral mucosal and sublingual formulations, which means that the TGA's decision to exclude CBD topicals and vaping products from the change will not affect them.  

However, Entoura has also stated that the S3 registration pathway can be a lengthy process to complete, which means we are unlikely to see products on the shelves until 2022 at the earliest.

According to the founding president of the Australasian College of Nutritional and Environmental Medicine (ACNEM), Professor Ian Brighthope, the decision to down-schedule CBD should be seen as a positive step forward, although he questioned whether the changes went far enough.  

"The down-scheduling of CBD to over-the-counter status is welcome but is unlikely to usher in radical change to medicinal cannabis access in Australia," Brighthope said.  

"Chronically and seriously ill patients will still require prescription medicinal cannabis, as S3 low dose products are generally for non-chronic or self-limiting conditions, as reflected in the 150mg daily dosing and maximum bottle size for products."

Any doctors or specialists requiring further information about products can register for the Entoura Cannabis Support Portal.


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Hugo Gray
Hugo Gray

Hugo Gray is a Melbourne-based journalist with a body of work that covers a diverse range of topics, including immigration law, sex technology, and now the rapidly expanding cannabis industry.