The ARTG: Registered vs Unregistered Medicines

Two columns on one register , and why it matters enormously for cannabis

Roughly 99% of medicinal cannabis products supplied in Australia sit in a single column of the Australian Register of Therapeutic Goods: "unregistered." Most people reading about cannabis access never stop to ask why, or what the alternative even looks like. That question turns out to explain quite a lot about how prescribers, pharmacists and patients navigate the system.

The ARTG , the Australian Register of Therapeutic Goods , is the TGA's central database of therapeutic goods that may legally be supplied in this country. Every medicine, device and biological that crosses a certain threshold of supply must appear on it. But "appearing on the ARTG" is not a single status. The register has distinct entries for registered goods and for listed or unregistered goods, and the obligations attached to each are markedly different.

Registered medicines: the full evaluation pathway

A registered medicine has been through the TGA's full pre-market evaluation. That means the sponsor has submitted clinical evidence of efficacy, not just safety and quality. The TGA reviews trial data, assesses the risk-benefit profile for a specific indication, and; if satisfied, approves the product for that use. The medicine gets an AUST R number on its label. Doctors can prescribe it, PBS listings become possible, and the approved indication can be stated in labelling and advertising (within the bounds of the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code).

There is exactly one cannabinoid medicine that has completed this pathway in Australia: a cannabidiol-based oral solution, approved for specific seizure types in specific patient populations. One product, one indication, years of trial data, a registered AUST R entry. That is the full-evaluation pathway working as designed.

Everything else, the oils, capsules, flower, and other formats that the vast majority of medicinal cannabis prescriptions in Australia are written for; is unregistered.

Unregistered goods and the access schemes that enable them

An unregistered therapeutic good is not the same as an illegal one. The TGA operates two principal pathways that allow unregistered medicines to be lawfully supplied to patients: the Special Access Scheme (SAS) and the Authorised Prescriber (AP) scheme. Both require the product to hold an ARTG entry, but as an "unregistered" good assessed for inclusion under the relevant pathway criteria, not as a fully evaluated registered medicine.

Under SAS Category B (the most commonly used pathway for medicinal cannabis), a registered medical practitioner notifies the TGA each time they supply an unapproved product to an individual patient. Since 2021, low-risk SAS B applications for medicinal cannabis have been largely self-assessed, the prescriber notifies rather than seeks explicit approval, provided the product is on the TGA's list of products assessed as lower risk. The Authorised Prescriber pathway works differently: a doctor obtains approval from the TGA (often with Human Research Ethics Committee endorsement, or in some cases via a college or specialist body) to prescribe a specified unapproved product to a class of patients, removing the need for per-patient notification.

Neither pathway requires the sponsor to have demonstrated efficacy to the same standard as a registered medicine. Quality and manufacturing standards still apply; Good Manufacturing Practice compliance is required for products supplied through these routes, but the evidentiary bar for clinical proof of effect is lower.

What AUST L, AUST R and AUST R(A) actually mean on a label

Three identifiers appear on TGA-regulated products in Australia, and it is worth being precise about them.

AUST R, a registered medicine. Full pre-market evaluation completed, including assessment of efficacy for a stated indication.

AUST L; a listed medicine. Lower-risk products (mostly complementary medicines) assessed primarily for safety and quality, not efficacy. Sponsors self-certify that the product contains only permitted ingredients at permitted levels. A medicinal cannabis product cannot currently hold an AUST L entry because cannabis is not an ingredient permitted in the listed medicines pathway.

AUST R(A), a registered medicine evaluated through an abbreviated pathway, typically because it relies substantially on evidence accepted by a comparable overseas regulator. Some products receive this designation when Australian evaluation draws on, say, FDA or EMA decisions.

Unregistered medicinal cannabis products supplied through SAS or AP pathways carry neither an AUST L nor an AUST R number in the conventional sense. Their ARTG entry exists for the purpose of the access pathway, it records that the product has been assessed as eligible for supply through those schemes; but the entry does not confer registered status or authorise the sponsor to make efficacy claims in labelling.

I'll admit I got this confused for longer than I'd like when I first started reading TGA guidance. The ARTG entry for an SAS/AP product looks, at a database level, like it "exists", but the regulatory weight behind it is substantially different.

Scheduling runs alongside ARTG status, they are not the same thing

A common source of confusion: ARTG registration and scheduling under the Poisons Standard are separate instruments, even though they interact closely.

The Poisons Standard (currently the Poisons Standard 2015, as amended) determines the scheduling of substances; Schedule 4 (Prescription Only), Schedule 8 (Controlled Drug), and so on. Most medicinal cannabis products containing THC above certain thresholds sit in Schedule 8. Low-dose CBD products meeting specific criteria moved to Schedule 4 (from Schedule 8) following a 2020 amendment, and a narrow category of very-low-dose CBD became Schedule 3 (pharmacist-only) in 2021, though accessing that Schedule 3 pathway in practice has remained difficult because no product had yet secured the required ARTG registration for that specific use at the time of writing.

ARTG status tells you whether a product is approved for supply and on what basis. Scheduling tells you who can prescribe it and under what controls. A product can be on the ARTG and still be Schedule 8. Those are two separate questions answered by two separate regulatory instruments.

Why most cannabis products remain unregistered, and whether that is a problem

The honest answer to why most medicinal cannabis products are unregistered is straightforward: full registration is expensive, slow, and requires a body of clinical trial evidence that most sponsors of cannabis products have not yet accumulated. The SAS/AP route is faster and commercially viable. For sponsors, it works. For prescribers, it is functional, if administratively more complex than writing a script for a registered medicine.

My view; and I reckon this is a reasonable one even if it is not universally shared, is that the current arrangement works adequately as a transitional mechanism but leaves some genuine gaps. Patients supplied under SAS or AP pathways have less publicly available, formally evaluated evidence on which to base shared decision-making with their prescribers than they would for a registered medicine. The TGA's published SAS data (accessible via the TGA website's annual reporting) gives aggregate numbers on supply by indication, but it is aggregate data, not a substitute for registered-product-level evidence review.

That gap matters most when you consider that CBD formulations differ substantially, in bioavailability, carrier oils, and whether they are full-spectrum, broad-spectrum, or isolate; and none of those differences are meaningfully captured by ARTG unregistered status.

Anyway. The system is what it is, and understanding it is the starting point.

GMP, quality, and what unregistered does not mean

Worth being explicit: "unregistered" does not mean unregulated, substandard, or outside the manufacturing quality framework. Sponsors of unregistered medicinal cannabis products supplied through SAS/AP pathways must comply with TGA GMP requirements. The TGA conducts GMP audits of Australian manufacturers and assesses overseas manufacturing sites through its GMP clearance process. Products must meet specified quality standards, identity, potency, purity, and the TGA has enforcement powers where those standards are not met.

The distinction between registered and unregistered is about the level of pre-market efficacy evaluation, not about whether manufacturing quality controls apply. Both registered and unregistered medicinal cannabis products on the ARTG are subject to GMP. This point gets lost in a lot of public discussion, and it is worth holding onto.

I spent a Saturday morning last year going through TGA GMP inspection outcome summaries; not my most thrilling weekend, Trevor the sourdough starter got more attention than usual, and the inspection framework for cannabis manufacturers is genuinely substantive, not a rubber stamp.

Sources

• Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration (TGA)
• Medicinal Cannabis: Access pathways; Therapeutic Goods Administration (TGA)
• Poisons Standard 2015 (current), Federal Register of Legislation
• Special Access Scheme Annual Report, Therapeutic Goods Administration (TGA)

, Marcus Hale, Regulatory researcher; TGA & access law