Special Access Scheme Category C

The access pathway that most people misread

Roughly 150,000 SAS Category C notifications were submitted to the TGA in the 2022–23 financial year. That number gets quoted a lot , usually to show how quickly medicinal cannabis uptake has grown. What gets quoted far less often is what Category C actually is, mechanically, and how it differs from the other pathways sitting alongside it. I've spent more time than I'd like to admit reading the relevant legislative instruments, so let me walk through it properly.

The Special Access Scheme is the TGA's framework for supplying unapproved therapeutic goods to individual patients. "Unapproved" here means the product doesn't hold full registration on the Australian Register of Therapeutic Goods , the ARTG , for the indication and patient population in question. Most medicinal cannabis products in Australia sit in exactly that position. They are lawfully manufactured and lawfully supplied, but they are not fully registered medicines in the conventional sense. The SAS is how they reach patients.

There are three categories within the SAS. Category A covers seriously ill patients with life-threatening conditions, where time pressure matters enormously. Category B requires the prescribing doctor to apply to the TGA and wait for approval before supplying; the TGA actively reviews each application. Category C is different again. It is a notification pathway, not an approval pathway.

What "notification" actually means

Under SAS Category C, the TGA has assessed the product class and determined that the risk profile is sufficiently understood to allow supply without case-by-case regulatory review. The prescribing doctor, or more precisely, the approved supplier, which in practice is usually the prescribing doctor, notifies the TGA that supply has occurred. The TGA does not pre-approve each individual patient's access. Notification happens within 28 days of supply.

This is a meaningful distinction. Under Category B, the regulator is an active gatekeeper before supply. Under Category C, the regulator receives a record after supply. The regulatory burden on the practitioner is substantially lower, which is a large part of why Category C notifications have grown so sharply year on year since the pathway was opened up for medicinal cannabis products in 2021.

For a product to be eligible for Category C, the TGA must have specifically listed it as appropriate for that pathway. For cannabis medicines, this was formalised through amendments to the Therapeutic Goods (Excluded Goods) Determination and subsequent guidance. Low-cannabidiol products meeting certain composition thresholds, and a broader set of products containing THC, have been brought within Category C scope through this process. The current eligible product list is published on the TGA's website and updated periodically; it's worth checking the primary source rather than relying on a summary, because the detail matters.

Who can notify, and what they need

Not every Australian doctor can submit a Category C notification for cannabis. The prescriber must be an approved prescriber under the SAS, which means they need to have registered with the TGA's notification portal. For Schedule 8 products, which covers products containing THC above certain thresholds, there are additional state and territory requirements that layer over the federal framework. Schedule 8 controlled drugs sit in the Poisons Standard and are subject to state-level controlled drug legislation as well. A practitioner in New South Wales, for example, must hold the relevant authority under NSW Health's controlled drugs framework on top of the federal SAS notification.

Lower-THC products that fall within the Schedule 4 prescription-only tier carry fewer state-level controls, though they still require a valid prescription and must originate from a TGA-listed supplier. The interaction between the federal Poisons Standard and eight different state and territory controlled drug regimes is, honestly, one of the more convoluted aspects of the whole system. I've seen experienced GPs caught out by it.

The notification itself, submitted through the TGA's online Business Services portal, requires product details, prescriber details, and patient details. The TGA collects these primarily for pharmacovigilance purposes, they want to track what is being supplied, to whom, and in what quantities. That data informs future scheduling and access decisions.

How Category C sits alongside the Authorised Prescriber pathway

A frequent source of confusion is the relationship between SAS Category C and the Authorised Prescriber scheme. They are parallel pathways, not sequential ones. An Authorised Prescriber has received approval from the TGA (usually supported by endorsement from a specialist college or human research ethics committee) to prescribe a specific unapproved product to a class of patients, without needing to notify for each individual. It is a higher upfront regulatory burden that removes the per-patient notification requirement altogether.

For practitioners who see a substantial volume of patients for whom cannabis products are clinically relevant, the Authorised Prescriber pathway can be administratively lighter over time; once the initial approval is secured. For practitioners who see fewer patients or who are just starting out in this space, Category C is typically the more practical entry point.

Neither pathway should be read as a signal about the clinical suitability of a product for any individual. The regulatory framework determines how supply is managed. Clinical decision-making is a separate matter entirely, sitting with the treating practitioner.

GMP requirements and the supply chain

Products supplied under Category C must come from a TGA-licensed manufacturer or a foreign manufacturer meeting equivalent Good Manufacturing Practice standards. This is non-negotiable. It's part of what distinguishes the licit supply chain from unregulated products, and it shapes what's actually available to prescribers. Not every cannabis product type or cannabinoid profile has a TGA-approved manufacturing source, which puts a practical ceiling on what can be accessed through the SAS.

I was flipping through some old survey maps of the ACT tablelands a few weekends ago, yes, I do this, and I ended up thinking about how much regulatory infrastructure gets quietly built into supply chains before a product ever reaches anyone. The GMP requirements for medicinal cannabis are genuinely detailed. Batch testing, stability data, chain of custody records. It's not glamorous, but it's the scaffolding that makes a lawful access pathway function.

Cannabis products covered by Category C span a range of formulations and cannabinoid compositions. Oils, capsules, dried flower for inhalation (subject to additional prescriber considerations); the composition of any given product, including its CBD-to-THC ratio and the presence of other compounds such as minor cannabinoids or terpenes, is determined by the manufacturer and must be accurately represented on the product's label and documentation.

The notification numbers in context

The TGA publishes quarterly data on SAS Category C notifications, and the medicinal cannabis figures within that data have become a marker that various stakeholders use to characterise the "state of the industry." I'd urge a bit of caution in how those numbers are interpreted. A notification reflects a supply event, one patient, one product, one supply period. A single patient receiving ongoing supply will generate multiple notifications over time. The raw notification count is not equivalent to a patient count, and it is definitely not a clinical outcomes dataset.

That said, the growth is real and the trend is clear. The Category C pathway, by removing the pre-approval step, meaningfully reduced the friction for prescribers and almost certainly contributed to the expansion of access. Whether the current balance between accessibility and oversight is calibrated correctly is a legitimate regulatory policy question. My view is that the per-patient notification requirement, even if it's post-hoc, provides a level of data granularity that is worth preserving, and that any future reform should be careful not to gut that pharmacovigilance function in the name of further streamlining.

Where to check current eligibility

The eligibility list for Category C changes. Products are added and occasionally removed as the TGA's assessment of the evidence base evolves. The definitive source is the TGA's SAS guidance page at tga.gov.au, not third-party summaries. If you are a practitioner trying to determine whether a specific product is currently eligible for Category C notification, the primary source is the only reliable one. The same applies to state and territory controlled drug authority requirements, which are published by each jurisdiction's health department.

For background on the broader regulatory architecture around cannabinoid compounds, the glossary entries on the Schedule 8 controlled drug classification and the ARTG are worth reading alongside this. And for those curious about the chemistry underneath the regulatory categories, the entries on the endocannabinoid system and individual compounds like cannabidiol provide useful context for understanding why different products attract different scheduling treatment.

Sources

• Special Access Scheme Category C; Therapeutic Goods Administration (TGA)
• Accessing Medicinal Cannabis Products, Therapeutic Goods Administration (TGA)
• Therapeutic Goods (Poisons Standard, February 2024) Instrument; Federal Register of Legislation
• Medicinal Cannabis: What You Need to Know, Australian Government Department of Health

, Marcus Hale, Regulatory researcher, TGA & access law