Unapproved Therapeutic Goods: The Legal Basis

About 97% of medicinal cannabis products accessed in Australia each year are never entered on the Australian Register of Therapeutic Goods. That figure comes from TGA's own access pathway data, and it surprises almost everyone who hears it the first time. People assume "legal" means "fully approved." In Australian therapeutic goods law, those two things are genuinely not the same.

What "unapproved" actually means under the Therapeutic Goods Act

The Therapeutic Goods Act 1989 (Cth) , the Act, for short , sets up a system where any good represented to have a therapeutic use must generally be included on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied. "Included on the ARTG" is what most people mean when they say a product is "approved."

But the Act also provides several lawful exemptions , pathways through which unapproved goods can reach patients without ARTG inclusion. The product remains unapproved in the formal sense. The supply, however, is lawful, provided the pathway conditions are met. That distinction is doing a lot of work in Australian cannabis law, and it's worth sitting with it for a moment.

Unapproved does not mean unregulated. It does not mean unsafe by default. It means the product has not gone through the full pre-market evaluation that results in ARTG listing or registration. The two main access pathways that make this lawful are the Special Access Scheme (SAS) and the Authorised Prescriber (AP) framework.

The Special Access Scheme and Authorised Prescriber pathways

The SAS has three categories. For medicinal cannabis, the practically relevant one is SAS Category B, which allows a medical practitioner to apply to the TGA to supply a specific unapproved product to a specific named patient. The TGA assesses each application and, if approved, the practitioner can prescribe. Category C is a notification-only pathway for certain lower-risk products; some low-dose cannabidiol preparations have been added to the Category C list, meaning a practitioner notifies TGA rather than seeking prior approval.

The Authorised Prescriber scheme takes a different approach. A practitioner applies to the TGA (or, in some specialties, to a human research ethics committee) to be authorised to prescribe a specific unapproved product to a class of patients with a particular condition. Once authorised, they can prescribe to multiple patients without individual applications, though they must report patient numbers to TGA every six months.

Both pathways sit under Section 19 of the Therapeutic Goods Act, which provides the legal basis for supplying unapproved goods to meet clinical need. Practitioners carry responsibility for their prescribing decisions under these pathways in a way that is different from prescribing a fully approved medicine, the normal product information and TGA-evaluated labelling claims do not apply.

Scheduling: the Poisons Standard layer

On top of the therapeutic goods framework sits a second layer: the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons, or SUSMP), which determines how a substance is scheduled and therefore who can prescribe and supply it. The two schedules most relevant to cannabis products are Schedule 4 (Prescription Only) and Schedule 8 (Controlled Drug).

The general rule, as it stands: cannabis products containing more than 2% of tetrahydrocannabinol (THC) are Schedule 8, meaning they are controlled drugs with additional state and territory permit requirements layered on top of the federal framework. Products where cannabidiol (CBD) is the primary cannabinoid and THC is below 2% sit at Schedule 4, prescription only. There is also a narrow Schedule 3 (pharmacist-only) entry for low-dose CBD products meeting specific criteria, though the practical uptake of that pathway has been limited.

State and territory legislation then mirrors or adds to this. Practitioners prescribing Schedule 8 cannabis products in, say, the ACT must comply with both the federal SAS or AP approval and any additional ACT permit conditions. It stacks. I've lost count of the number of times I've seen practitioners caught out by that second layer; not because they were careless, but because the federal-state interaction is genuinely not obvious.

Good Manufacturing Practice and the quality floor

One of the more substantive requirements that does apply to unapproved medicinal cannabis is Good Manufacturing Practice (GMP). Manufacturers of medicinal cannabis, whether Australian or overseas, must hold, or manufacture under, a TGA licence or equivalent certification. This is the quality floor that distinguishes lawfully supplied medicinal cannabis from illicit product.

GMP compliance means standardised manufacturing processes, testing for potency and contaminants, batch records, and traceability. A product can be unapproved (not on the ARTG) and still need to meet GMP. That's a point that sometimes gets lost in shorthand discussions of "approved versus unapproved."

It's also why the chemistry of the product matters from a regulatory perspective. Whether a preparation is a full-spectrum extract; containing the breadth of cannabinoids and terpenes present in the source plant, or a CBD isolate, it still needs to have been manufactured to GMP standard and needs consistent, tested cannabinoid content to be lawfully supplied through these pathways.

The one approved product and what it tells us

As of mid-2025, there is one medicinal cannabis product registered on the ARTG in the conventional sense, a plant-derived CBD oral solution approved through the standard registration pathway. Everything else accessed through SAS or AP remains technically unapproved. That asymmetry tells you something about both the cost of full registration and the practical functionality of the access pathways: they are doing what they were designed to do, which is to provide lawful access at scale without the full pre-market evaluation burden.

Honestly, I reckon this is one area where the Australian framework has been more pragmatic than it often gets credit for. The SAS and AP pathways were not designed specifically for cannabis; they predate it, but they have been adapted and expanded to handle the volume. The TGA has streamlined Category C notifications and the AP scheme has grown significantly since 2016. That said, the patchwork of state-level Schedule 8 permit requirements remains genuinely clunky, and a national harmonisation effort is long overdue.

What this means for understanding product descriptions

When reading about cannabinoid products in an educational context, the regulatory status of any given substance or preparation is always relevant context. Cannabigerol (CBG), for instance, is a minor cannabinoid present in some full-spectrum preparations; its scheduling status follows the overall cannabis plant entry in the Poisons Standard. The same logic applies to lesser-discussed cannabinoids that might appear in research literature.

The Special Access Scheme pathway also has implications for how pharmacokinetic data gets used in clinical decision-making, without full ARTG registration, there is no TGA-approved product information document specifying absorption, distribution, metabolism and excretion. Prescribers working under SAS or AP must draw on published research and manufacturer data, which is a meaningful difference from prescribing a fully evaluated medicine.

I went back through some of the TGA's published access data last month, partly for a project I was working on and partly because I'd told myself I'd finally get Trevor (the sourdough) to a reliable 12-hour rise before the weekend. One thing stands out in that data: approval numbers through both pathways have roughly doubled every two years since 2017. The legal infrastructure hasn't changed fundamentally; what changed is practitioner familiarity and confidence in using it.

The compliance boundary: what supply without a pathway looks like

Supply of a therapeutic good, including a cannabis product, outside the ARTG and without a lawful exemption is a criminal offence under the Therapeutic Goods Act. The penalties are substantial: up to five years imprisonment and/or significant financial penalties for individuals, higher for corporations. The TGA has regulatory powers to issue infringement notices, seek injunctions, and pursue prosecution.

This applies to supply, not merely possession (which is a state/territory matter). The Act's supply prohibition is federal. An entity selling an unapproved product and representing it as having a therapeutic use, without operating under a valid SAS or AP approval and the required manufacturing authorisation, is operating outside the law; regardless of whether the underlying substance has pharmacological activity of interest in research settings.

For readers who want to understand how specific cannabinoids slot into this framework, whether we're talking about CBD, THC, or the range of minor cannabinoids appearing in research literature, the scheduling entry in the current Poisons Standard is always the authoritative reference. The TGA publishes the current SUSMP on its website and updates it after each scheduling delegate decision.

Sources

• Special Access Scheme; Therapeutic Goods Administration (TGA)
• Therapeutic Goods Act 1989 (Cth), Federal Register of Legislation
• Medicinal Cannabis Hub, Therapeutic Goods Administration (TGA)
• Poisons Standard (SUSMP); Therapeutic Goods Administration (TGA)

, Marcus Hale, Regulatory researcher, TGA & access law

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