Are Non-ARTG listed Devices Illegal?

“Hang on. It’s not on the ARTG's list… so how are you selling it?”

It’s a fair question — and one that often comes up when comparing medicinal cannabis vaping devices.

A pharmacist may be looking at two devices: one is included in the ARTG, while the other isn’t.

So naturally, the question becomes:

Does that automatically make the non-ARTG device illegal?

No — but there’s more to the answer.

A non-ARTG medicinal cannabis vaping device is an unapproved therapeutic good.

That doesn’t automatically make it illegal, but it also doesn’t mean it can simply be supplied to any patient.

The TGA advises that ARTG-included medicinal cannabis vaping devices should be used wherever possible. In limited circumstances, where a prescriber considers the ARTG-included options unsuitable for a patient’s clinical situation, access to an unapproved device may be sought through pathways such as SAS Category B or the Authorised Prescriber pathway, subject to the applicable requirements.

For pharmacists, think PATHWAY — not just PRODUCT.

ARTG-INCLUDED
→ Included in the Australian Register of Therapeutic Goods.
→ The device itself does not require separate SAS or AP access before it can be supplied through a pharmacy.

NON-ARTG
→ An unapproved therapeutic good.
→ Patient supply requires the applicable access requirements to be met.

That distinction is important because having the device in Australia is not the same as having authority to supply it to a patient.

Imported ≠ authorised for patient supply.

An unapproved medicinal cannabis vaping device may, in certain circumstances, be imported in anticipation of supply under an applicable SAS or AP pathway.

But until the relevant requirements for patient supply have been met, the device must remain under the importer’s control.

So, what should you check?

When you're dealing with a medicinal cannabis vaping device, start with three questions:

1. Is it ARTG-included or unapproved?
2. If it’s unapproved, what access pathway applies?
3. Are the applicable requirements in place before patient supply?

You don’t need to memorise every regulatory pathway.

You need to recognise when one needs to be checked.

REMEMBER THIS

NON-ARTG ≠ automatically illegal.
NON-ARTG ≠ automatically available.

The pathway matters.

DON'T JUST TAKE OUR WORD FOR IT

TGA — Medicinal cannabis information for health professionals

TGA — Medicinal cannabis vaping devices: Information for importers, exporters and manufacturers

The TGA explains the distinction between ARTG-included and unapproved medicinal cannabis vaping devices, the applicable access pathways, and the requirements around importation and patient supply.