Special Access Scheme Category B

The pathway most people have heard of but few fully understand

Roughly 90% of medicinal cannabis approvals in Australia flow through a single regulatory channel. Not through hospital ethics committees, not through drug trials, and not , despite what you might assume , through the Authorised Prescriber scheme. They come through the Special Access Scheme Category B, a mechanism that has existed in Australian law since the early 1990s and has been quietly reshaped into the backbone of the country's unapproved medicines access system.

I've spent a fair amount of time in the weeds of the Poisons Standard and the Therapeutic Goods Act, and I'll admit: SAS Category B is the one that generates the most confused questions. People conflate it with the SAS broadly, or with the Authorised Prescriber pathway, or think it's somehow experimental or provisional. It isn't , or at least, not in the way they imagine. So let me walk through how it actually works.

What the Special Access Scheme is, structurally

The Special Access Scheme exists under Section 18 of the Therapeutic Goods Act 1989 (Cth). Its purpose is to allow Australian patients to access therapeutic goods that have not been entered on the Australian Register of Therapeutic Goods; the ARTG. A product on the ARTG has completed the TGA's full evaluation and approval process. An unapproved product hasn't. SAS is, in effect, a supervised bypass for specific patients who may benefit from goods outside that approved list.

The scheme has three categories. Category A covers patients who are "seriously ill with a condition that is likely to be life threatening," where the practitioner self-assesses and notifies the TGA after the fact. Category C is a streamlined pathway for certain listed products. Category B, the most commonly used, sits in the middle and covers the broadest range of unapproved products, including most medicinal cannabis.

How SAS Category B actually works

Under SAS Category B, a registered medical practitioner (or, in some cases, a nurse practitioner) submits an application to the TGA on behalf of a specific, named patient. The application is for a specific product, a specific indication, and a specific quantity. It is not a blanket licence. Each new patient requires their own application, and the TGA assesses each one.

The TGA generally aims to assess SAS Category B applications within 48 hours for urgent requests and within a few business days otherwise, though in practice timelines have varied. Approval is product-specific: the prescriber nominates the product they intend to prescribe, and approval is granted; or not, for that product, for that patient.

For cannabis-based products specifically, most products supplied in Australia under SAS Category B are Schedule 8 controlled drugs under the Poisons Standard, meaning state and territory controlled drugs legislation also applies once TGA approval is obtained. Some low-CBD products with no or negligible THC fall under Schedule 4 (prescription only), which carries fewer state-level restrictions, but the TGA federal approval step is the same.

One thing that surprises people: approval under SAS Category B does not mean the product is registered on the ARTG. The product remains unapproved. The approval is a patient-specific permission, not a product endorsement.

Who can apply, and what they're submitting

Applications are made by the treating practitioner, not by the patient, not by a pharmacy, not by a manufacturer. The practitioner uses the TGA's online portal (the TGA Business Services portal, for those who've navigated it) and submits a clinical justification for why the unapproved product is appropriate for this patient.

That justification matters. The TGA assesses whether there is a legitimate clinical basis for the request, whether the product is manufactured to an acceptable standard; which in practice means looking at whether the supplier holds evidence of Good Manufacturing Practice certification, and whether the quantity requested is appropriate. Applications for products from suppliers without credible manufacturing quality evidence are more likely to be scrutinised or refused.

I'll be direct about something here: the volume of SAS Category B approvals has grown dramatically since 2016 when the TGA rescheduled cannabis products. By the TGA's own published data, monthly approvals for medicinal cannabis under SAS Category B went from a few hundred in 2018 to well over 30,000 per month by late 2022. That growth has put genuine strain on the assessment process, and there are reasonable questions, ones I think haven't been fully answered; about whether the per-application clinical review is as substantive at high volume as it was at low volume. The TGA's published guidance is clear on what's required; whether every application receives the same depth of scrutiny in practice is a different matter.

SAS Category B versus the Authorised Prescriber pathway

The two pathways are often described as alternatives, and they are, but they work differently enough that conflating them causes real confusion.

Under the Authorised Prescriber scheme, a practitioner applies once to become authorised to prescribe a specific unapproved product (or class of product) to a class of patients with a specified indication, without seeking per-patient TGA approval each time. It requires endorsement from either a specialist college or a Human Research Ethics Committee, and it's designed for practitioners with genuine clinical depth in the area. Once approved, the prescriber notifies the TGA of patients treated, rather than seeking pre-approval.

SAS Category B, by contrast, requires a new application for every patient. It's more flexible for practitioners who see only occasional patients who might benefit from a given unapproved product, and it doesn't require specialist college endorsement. Most GPs who prescribe medicinal cannabis use SAS Category B rather than the Authorised Prescriber pathway for this reason.

Neither pathway involves the TGA recommending that a patient seek or use any product. Both are mechanisms for practitioners to request access, the clinical decision-making rests entirely with the prescribing practitioner.

State and territory obligations stack on top

Something that genuinely trips people up: TGA approval under SAS Category B is a federal permission. It doesn't override state and territory medicines laws. For Schedule 8 cannabis products, most states and territories require a separate permit from the relevant health department before the prescription can be written and dispensed. Queensland, for instance, requires Schedule 8 permits under the Health (Drugs and Poisons) Regulation 1996; New South Wales has its own controlled drug framework.

I was reviewing some Northern Territory permit documentation last month; not the most exciting Saturday, I know, though in fairness Trevor the sourdough starter was doing his own thing and didn't need me, and the layering of federal TGA approval plus territory permit plus pharmacy dispensing requirements is genuinely intricate. It's not prohibitive, but it's not trivial either, and practitioners who are new to prescribing in this space sometimes underestimate the state-level obligations.

What SAS Category B does not cover

The scheme is not a pathway for importing products for personal use. It does not allow patients to self-apply. It does not cover products that contain unapproved substances at levels that would constitute a different controlled drug classification. And, worth stating plainly; TGA approval under SAS Category B does not mean a product has been evaluated for efficacy or safety in the way a registered medicine has. The TGA's assessment is focused on whether access is appropriate for this patient, not on a full benefit-risk evaluation of the product class.

That distinction matters for how we read the published approval numbers. The volume of SAS Category B approvals tells us something about prescriber and patient demand; it tells us rather less about the evidentiary base for any given product's use. Understanding how compounds like cannabidiol interact with the endocannabinoid system at a mechanistic level is a separate body of science from the regulatory question of access.

Sources

• Special Access Scheme, Therapeutic Goods Administration (TGA)
• Therapeutic Goods Act 1989 (Cth), Federal Register of Legislation
• Medicinal Cannabis Access in Australia: An Overview; TGA
• Medicinal Cannabis, Alcohol and Drug Foundation (ADF)

, Marcus Hale, Regulatory researcher, TGA & access law