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TGA approves over-the-counter sales of cannabidiol products

Australia’s Therapeutic Goods Administration (TGA) has approved the introduction of over-the-counter sales of low-dose CBD products in Australian pharmacies from 1 February 2021. The decision down-schedules low dose CBD preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).


The decision has led to CBD products containing up to a maximum of 150mg/day, for use in adults, to be sold by a pharmacist to customers without a prescription. Products must be approved by the TGA and included on the Australian Register of Therapeutic Goods.


ASX-listed Creso Pharma welcomed the decision as a major development for the Australian medicinal cannabis industry and highlights a large market opportunity that is estimated to exceed $200 million per annum.


Creso Pharma believes it is very well placed to capitalise on the growing market opportunity in Australia. The company has an existing portfolio of CBD products being actively sold in several countries globally, with its flagship CannaQIX product already available in Australia via prescription, under the LozaCan brand.


The company has also entered into a strategic agreement with leading natural, sustainable health and lifestyle brand supplier Martin & Pleasance to bring Creso’s suite of cannabis-based products to the Australian market, as previously announced in December. Martin & Pleasance has its own in-house regulatory team and a workforce directly servicing over 4,000 pharmacies in Australia and New Zealand, as well as online channels, grocery and practitioner suppliers.


Non-executive Chairman Adam Blumenthal said: “Today is a major milestone for the Australian medicinal cannabis industry, which we anticipate will grow rapidly over the coming months. The TGA’s decision to allow the sale of low–dose CBD products to consumers without a prescription provides Creso Pharma with another exciting opportunity to grow in Australia and another potential revenue stream for the Company. We will continue to work with Martin & Pleasance to define the specific regulatory pathway for our product in the Australian market and look forward to proving its superiority through the ARTG registration process. Creso continues to progress a number of growth initiatives in Australia and internationally and looks forward to updating shareholders as developments materialise.”