Special Access Scheme and Authorised Prescriber Scheme in Australia: What Patients and Prescribers Need to Know

Most medicines used in Australia are fully approved by the Therapeutic Goods Administration (TGA) and listed on the Australian Register of Therapeutic Goods (ARTG). But some patients need access to a treatment that isn’t yet on that register, often because it’s newly developed, used off-label, or, most commonly in practice, a medicinal cannabis product. Two Commonwealth pathways make this legal and possible: the Special Access Scheme (SAS) and the Authorised Prescriber (AP) Scheme. This guide explains what each means for patients, how a doctor becomes an Authorised Prescriber, whether a nurse practitioner can prescribe unapproved medicines, and where to find each state and territory’s official rules.

What Is the Special Access Scheme (SAS)?

The Special Access Scheme is the TGA framework that lets a registered health practitioner legally access an “unapproved” therapeutic good (one not entered on the ARTG) for a single, named patient on a case-by-case basis. It exists because a product not being on the ARTG doesn’t mean it’s unsafe or ineffective; it often just means no company has completed the (expensive, lengthy) registration process for the Australian market. SAS is split into three categories, and which one applies depends entirely on how urgent and well-established the treatment need is.

SAS Category A: for seriously ill patients

Category A applies when a patient is seriously ill with a condition they’re likely to die from, or from which they’d suffer serious and permanent disability, and there’s no comparable therapeutic alternative already available. It is self-authorising: the prescriber acts first and notifies the TGA afterwards, rather than waiting for approval. For a patient, this is the fastest route, but it’s deliberately reserved for genuinely urgent, high-stakes situations, not general convenience.

SAS Category B: the standard pathway

Category B is the pathway most patients encounter, including most medicinal cannabis patients. The prescriber (or their institution) applies to the TGA and must receive approval before the product is supplied. The TGA assesses the clinical justification for that individual patient. For patients, this means access is available, but only after the prescriber’s application clears TGA review, typically a matter of days, not months, but not instant.

SAS Category C: pre-approved product lists

Category C covers products the TGA has already determined have an established pattern of legitimate use for a given purpose, they sit on a published SAS Category C list. If a prescriber’s intended use matches a listed product and indication, they can supply it immediately without seeking individual approval first, but must notify the TGA within 28 days of supply. This is the closest SAS gets to “off-the-shelf” access.

What the SAS means for patients, in practice

The SAS does not mean a product is approved, tested to Australian standards, or risk-free. It means a doctor has judged, and in Category B and C cases the TGA has agreed or pre-agreed, that access is clinically justified for that patient. Patients should expect their prescriber to explain why the standard, ARTG-approved options weren’t suitable, and to monitor them more closely than they would for a registered medicine.

What Is the Authorised Prescriber (AP) Scheme?

The Authorised Prescriber Scheme solves a different problem: what happens when a prescriber expects to treat many patients with the same unapproved product for the same condition, not just one? Instead of lodging a fresh SAS Category B application for every single patient, a medical practitioner can apply to become an Authorised Prescriber for a specified unapproved good (or class of goods) and a defined class of patients with a particular medical condition. Once approved, that doctor can supply the product directly to any patient in their immediate care who fits the approved class, no per-patient TGA sign-off required.

SAS vs. AP Scheme at a glance

	Special Access Scheme (SAS)	Authorised Prescriber (AP) Scheme
Who can apply	Any registered health practitioner (SAS Cat A/B)	Registered medical practitioners only
Approval covers	One named patient at a time	A class of patients with a defined condition
Approval timing	Per patient (Cat A: after the fact; Cat B: before supply)	Once, then ongoing for future eligible patients
Best suited to	Occasional, individual need	Prescribers treating the same condition regularly
Reporting	Notification per patient/use	Periodic reporting to TGA on patients treated

How Does a Doctor Become an Authorised Prescriber?

Only a medical practitioner registered in an Australian state or territory, with the qualifications and experience to manage both the medical condition and the specific product — is eligible. The pathway generally runs as follows:

1. Confirm there’s no suitable ARTG-approved alternative. The TGA expects prescribers to first establish that a registered product wouldn’t reasonably meet the patient group’s needs.
2. Obtain HREC approval or specialist college endorsement. Before applying to the TGA, the doctor needs either approval from a Human Research Ethics Committee (HREC) or an endorsement from a relevant specialist college confirming the clinical justification.
3. Apply to the TGA through the SAS & Authorised Prescriber Online System. This is the TGA’s preferred and primary application channel, and it also bundles in any state or territory application needed for the same product (see the directory below; Tasmania is a notable exception and requires a separate process).
4. Meet ongoing reporting obligations. Authorised Prescribers must periodically report to the TGA on the patients they’ve treated under the approval, and reapply/renew as required.

For medicinal cannabis specifically, most states and territories layer an additional requirement on top of the TGA approval where the product is a Schedule 8 (controlled) medicine. See the state-by-state section below.

Can a Nurse Practitioner Prescribe Unapproved Medicines?

Yes, but with an important limit: nurse practitioners can prescribe under the Special Access Scheme, but they cannot become Authorised Prescribers. The AP pathway is restricted by the TGA to medical practitioners. A nurse practitioner treating an individual patient can still apply through SAS Category A or B (or use a Category C listed product) in exactly the same way a doctor would for a single patient. This covers most nurse practitioner-led medicinal cannabis prescribing in Australia today.

In practice, this means a nurse practitioner can legally prescribe medicinal cannabis and other unapproved therapeutic goods to individual patients under their care, provided they have the clinical expertise, follow the same evidence-based prescribing standards expected of medical practitioners (the Nursing and Midwifery Board of Australia and Medical Board of Australia both expect the same rigour applied to Schedule 8 prescribing generally, including thorough assessment and follow-up), and obtain any state or territory authority that applies in their jurisdiction where the product is a Schedule 8 medicine. What a nurse practitioner cannot do is apply for AP status to treat a whole class of patients without individual approvals; that scale pathway remains doctor-only.

State and Territory Authorised Prescriber and Cannabis Medicine Resources

The TGA administers SAS and AP nationally, but where the unapproved product is a Schedule 8 (controlled) medicine (which covers most THC-containing medicinal cannabis), most states and territories add their own layer of authorisation on top of the TGA approval. There is no single published, name-by-name national list of every Authorised Prescriber (this is treated as clinical and practitioner-identifying information); what states publish instead is official guidance on their own approval requirements and processes. The table below is a maintained directory of the official government resource for each jurisdiction.

State / Territory	Additional state approval needed?	Official resource
New South Wales	Yes, for Schedule 8 cannabis medicines to a drug-dependent person, in a clinical trial, or for a patient under 16	NSW Health – Access and approvals for cannabis medicines
Victoria	Generally no separate state authority for prescribing itself, provided Commonwealth approval is held	Victoria Health – Medicinal cannabis information for health professionals
Queensland	State requirements apply for certain patient groups/Schedule 8 use	Queensland Health – Prescribing medicinal cannabis
South Australia	Yes, in most cases; exemptions exist for patients over 70 and notified palliative care patients	SA Health – Medicinal cannabis patient access
Western Australia	No. WA removed the requirement for separate CEO authorisation for Schedule 8 medicinal cannabis prescribing in late 2024; extra approval still applies for patients under 16 or drug-dependent patients	WA Health – Medicinal cannabis products (S4 and S8)
Tasmania	Yes. A Section 59E authorisation under the Poisons Act 1971 is required for each patient before prescribing	Tasmanian Department of Health – Medicinal cannabis for prescribers
Australian Capital Territory	Yes. Chief Health Officer approval required for Schedule 8 medicinal cannabis, alongside TGA SAS/AP approval	ACT Government – Prescribing and supplying medicinal cannabis
Northern Territory	No specific additional NT regulation beyond the TGA pathway	NT Health – Therapeutic medicines containing cannabinoids

For aggregate national data on Authorised Prescriber approvals by product and indication (not individual prescriber names), see the TGA’s medicinal cannabis Authorised Prescriber Scheme data. Because state requirements change periodically, always confirm current rules against the official link before relying on them.

Getting access right

SAS and the Authorised Prescriber Scheme exist for the same reason: a medicine not being on the ARTG doesn’t mean it lacks a clinical case, only that no one has completed registration for the Australian market. Which pathway fits depends on whether you’re treating one patient or many, and what your state requires on top of the TGA approval. Because those state rules change, always confirm the current position against the official link for your jurisdiction before prescribing.

Byron Bioceuticals works directly with doctors and pharmacists across Australia. Get in touch to discuss access to our products, or visit our doctors and pharmacist pages.

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