What is the Special Access Scheme?
The Special Access Scheme (SAS) is a Therapeutic Goods Administration (TGA) pathway that allows individual patients to access unapproved therapeutic goods — goods not listed on the Australian Register of Therapeutic Goods (ARTG) — when a treating healthcare professional considers access appropriate. The SAS does not constitute a general approval of a product; each application is specific to a named patient and a named product, submitted by that patient's treating practitioner.
Most medicinal cannabis products in Australia currently reach patients through the SAS or the related Authorised Prescriber scheme, as the majority of these products are not yet included in the ARTG. The SAS enables legal supply of products that have not yet completed the full ARTG registration process, provided the relevant regulatory requirements are met and the appropriate application or notification is submitted.
The SAS is governed by the Therapeutic Goods Act 1989 (Cth) and associated regulations. Two categories exist within the SAS — Category A and Category B — which differ in their processes, administrative timeframes, and patient eligibility criteria. Understanding the difference between these categories is important for prescribers navigating the pathway and for patients who want to understand how access works.
Prescribers are responsible for determining patient eligibility, selecting an appropriate product, and managing clinical monitoring. The TGA's role in the SAS is regulatory rather than clinical: it administers the application process and checks that applications meet the relevant criteria, but it does not manage clinical care or advise individual patients on treatment suitability.
SAS Category A
Category A applies to patients who are seriously ill with a condition that is either immediately life-threatening or causes serious, permanent disability, and where the condition cannot be adequately managed with goods currently included in the ARTG. This is a high threshold — Category A is designed for urgent or compassionate access situations where a patient's circumstances are acute and waiting for a pre-approval process is not practicable.
A defining feature of Category A is that supply can proceed before the TGA is formally notified. Notification is made after supply rather than before it, which streamlines the administrative process in urgent situations. The treating healthcare professional must be satisfied that the patient meets the Category A criteria before proceeding, and they retain full responsibility for the clinical decision. The post-supply notification requirement means that the practitioner cannot rely on a TGA review to serve as a check on eligibility — that assessment must be made by the practitioner themselves.
Because the eligibility threshold for Category A is high, it does not apply to most routine medicinal cannabis prescriptions. The majority of patients accessing medicinal cannabis do so via Category B, where a pre-approval from the TGA is required before supply. Category A exists for situations where the urgency of the patient's circumstances makes the standard pre-approval process inappropriate.
Prescribers considering Category A should ensure they are familiar with the current TGA guidance on the Category A criteria, as these are defined in legislation and are not subject to clinical discretion. Applying Category A to a patient who does not meet the criteria creates regulatory and professional risk for the prescriber.
SAS Category B
Category B is the most commonly used SAS pathway for medicinal cannabis access in Australia. Under SAS Category B, the treating prescriber — typically a GP, specialist, or nurse practitioner with prescribing authority — submits an application to the TGA before supply. The product cannot be dispensed until the TGA has reviewed the application and issued an approval.
SAS-B applications describe the patient (without including name or contact details — applications use a patient identifier), the proposed treatment, the specific product being requested, and the clinical rationale for its use for an appropriate medical indication as determined by the healthcare practitioner. The TGA reviews applications for regulatory compliance — it checks that the application is complete and meets the relevant criteria — but it does not conduct an independent assessment of clinical efficacy for the individual patient.
Once a SAS-B approval is issued, it is specific to the named patient and the named product. It is not transferable to other patients, and it does not automatically extend to related products. If the prescriber wishes to change the product or make certain other changes, a new application may be required. Prescribers should consult the current TGA guidance on what changes require a new application and what changes can be managed within an existing approval.
Processing times for SAS-B applications can vary. The TGA publishes guidance on expected timeframes, and prescribers are encouraged to check the current TGA website for up-to-date information on processing. For most straightforward applications, the process is designed to be relatively efficient, but prescribers should factor in expected processing time when planning patient care.
The Authorised Prescriber pathway
The Authorised Prescriber (AP) scheme provides an alternative access pathway for practitioners who regularly prescribe a specific unapproved product to a defined class of patients. Rather than submitting an individual SAS-B application for each patient, an Authorised Prescriber can prescribe the relevant product to appropriate patients within the defined class without requiring a per-patient TGA approval.
To become an Authorised Prescriber, a medical practitioner applies to the TGA. In most cases, the application requires support from a Human Research Ethics Committee (HREC) or a specialist college, though the TGA has provisions for certain situations where this requirement can be modified. The application describes the specific unapproved product the practitioner wishes to prescribe and the class of patients for whom the practitioner intends to prescribe it. The TGA reviews the application and, if approved, grants the practitioner authority to prescribe that product to patients within the defined class.
The AP scheme reduces ongoing administrative burden for practitioners who see multiple patients who may benefit from the same product. Once authorised, the practitioner does not need to obtain individual TGA approvals per patient — they can prescribe to appropriate patients within their authorised scope without submitting SAS-B applications for each one. This makes the AP scheme particularly relevant for clinics or practitioners with high patient volume in the medicinal cannabis space.
Authorised Prescribers are required to report to the TGA on the number of patients treated at six-monthly intervals. This reporting requirement is part of the regulatory framework that governs the AP scheme. The AP approval is product-specific and patient-class-specific — it authorises prescribing of a particular product to a particular class of patients, and does not extend beyond those boundaries. Changes to the product or patient class require a new or amended AP application.
What patients need to know
Patients cannot initiate an SAS application themselves. All SAS applications must be submitted by a treating healthcare professional — typically the patient's GP, a specialist, or a prescriber at a clinic with experience in the medicinal cannabis space. Patients who are interested in exploring medicinal cannabis access should discuss this with their treating practitioner, who will assess whether the patient's circumstances meet the relevant criteria and whether an application is appropriate to pursue.
Not all general practitioners are familiar with the SAS process for medicinal cannabis, and some may choose not to prescribe it or may prefer to refer the patient to a specialist or a clinic with relevant experience. This is a normal part of the healthcare system — patients who are not able to access a willing prescriber through their existing GP may be referred onward or may seek a second opinion. Patients should not attempt to manage the application process themselves or seek informal access outside the regulated pathway.
Approval under the SAS or via an Authorised Prescriber is a regulatory approval that allows legal supply of the product to the named patient. It is not a clinical endorsement of outcome, and it does not guarantee that the product will be effective for a given patient's indication. Clinical decisions — including whether a product is appropriate for an individual patient's indication, what monitoring is required, and how to manage any changes in the patient's condition — remain the responsibility of the treating practitioner.
Patients accessing medicinal cannabis through the SAS or AP pathway should maintain regular contact with their prescriber, attend scheduled follow-up appointments, and report any changes in their condition or any concerns about the product they are using. The prescriber is the appropriate point of contact for clinical questions. Patients should not adjust their use or change products without consulting their prescriber first.
How devices fit in
When dried medicinal cannabis flower is prescribed for inhalation under the SAS or AP scheme, the patient also requires a suitable vaporisation device. The device and the cannabis product are regulated separately under Australian law and access them via distinct regulatory pathways.
The medicinal cannabis product itself — the dried flower or other form — accesses the market via the SAS or AP pathway as described above. The vaporisation device, if classified as a medical device, is regulated by the TGA under the medical device regulatory framework and must be included in the ARTG or accessed through an equivalent process before it can be lawfully supplied in Australia for medical use.
Patients and prescribers should be aware that not all vaporisation devices on the Australian market are medical devices or have been assessed by the TGA. Consumer-grade or recreational vaporisers marketed outside the therapeutic goods framework are not subject to the same regulatory requirements as ARTG-listed medical devices. For patients accessing dried medicinal cannabis flower under the SAS, using a device that is registered on the ARTG as a medical device — such as a Class IIb medical device — provides a level of device-side regulatory assurance that is not present with unregistered alternatives.
Prescribers can recommend or specify a vaporisation device as part of the treatment plan, and pharmacists can advise on device availability and supply. The choice of device is a clinical and practical consideration that falls within the scope of the prescriber's management of the patient's treatment. Patients should not independently substitute devices without discussing the change with their prescriber or pharmacist.