• The TGA down-scheduled low dose CBD in February for over-the-counter sales without a prescription
  • Currently no CBD drugs have been approved for sale in Australia
  • Cann Group reckons S3 registration could open the door to millions of patients in 2023


Technically, over-the-counter cannabidiol (CBD) products are legal in Australia without a prescription since the Therapeutics Goods Administration (TGA) down-scheduled lose dose CBD (150mg or less) from a schedule 4 to schedule 3 drug in February.

But don’t get too excited just yet.

Currently there are no CBD products approved for sale. And with the rigorous testing, clinical trials, and regulatory hurdles involved in registering any drug, it could be a while before we see products on pharmacy shelves.


A race to register in 2023

Late last year, FreshLeaf Analytics principal consultant Juno Wilson flagged that the race to have S3 registered CBD available over the counter at pharmacies in Australia was well and truly on.

“These things take quite a bit of time to make sure that products undergo the necessary processes to ensure quality, safety and efficacy,” Wilson cautioned.

“There are a number of companies currently in the product registration process and we don’t expect to see the first products available over the counter at pharmacies until late 2022/early 2023.”

But Cann Group (ASX:CAN) COO Shane Duncan says it will be more like mid-to-late 2023.

“I think it’s probably more like the middle to the second half of 2023,” he said.


Potential access to millions of Aussie customers

This month CAN entered an exclusive deal with GSK Consumer Healthcare to commercialise Cann’s Satipharm CBD capsules for short term relief of sleeplessness.

The company says the capsules will be sold over-the-counter (OTC) in Australia (S3 registration status), and potentially other markets globally using GSK’s distribution channels.

But what Duncan is really excited about is the number of patients a registered product can access versus those on the special access scheme.

“Sleeplessness products in pharmacies – vitamins, supplements and S3 OTCs – was about an $80m category in 2021,” Duncan said.

“FreshLeaf estimate there’s about 100-120,000 people accessing medicinal cannabis products via the SAS – this is many millions of patients or customers walking into a pharmacy.

“So, in terms of revenue and security of facilities and manufacturing capability, these registered products do significantly de-risk your business and give you that visibility on what recurring revenues will be.”

Cann’s Phase 3 CBD clinical trial is currently underway, with results expected in Q3.

“In parallel, we’re preparing our registration dossier with the aim of submitting to the TGA in late Q3, early Q4 this calendar year,” Duncan said.

“Then it’s a 9-12 month timeframe to reach TGA review.”




First to market not always the best prize

Then there’s Medlab Clinical (ASX:MDC), whose NanoCBD drug is available on the Australian Special Access Scheme, and this month MedLab announced it’s just waiting on the final import licence to export the product to the UK.

However, the company’s CEO and founder Dr Sean hall isn’t too worried about being first to market in Australia.

“We’re less worried about being first to market because the first to market people usually are the people that are going to be trundled,” he said.

“The TGA – whilst they may be motivated to get a cannabinoid into the registered medicines Act – are going to be rather difficult.”


CMC package trumps clinical trials

Dr Hall also said there’s a lack of understanding among investors and the market as to what it actually takes to get a drug approved.

“It’s not clinical trials but the Chemistry, Manufacturing and Controls (CMC) records that make up the bulk of the weight of the determination of a drug dossier,” he said.

And when a drug is botanical, and based on a plant with many variabilities, the CMC – which speaks to the precision and quality of the product – could become difficult.

MedLab is currently bolstering its CMC package, to be followed by pharmacokinetic data and tox before doing a light clinical trial “because we know that’s what we have to do for this registration process,” Dr Hall said.

The company is also in discussions with a potential partner which it says could fast-track its pathway to commercialisation globally.


At Stockhead we tell it like it is. While MedLab is a Stockhead advertiser, it did not sponsor this article.