Special Access Scheme (SAS)

Overview

The Special Access Scheme (SAS) allows health practitioners to access therapeutic goods — including medical devices — that are not included in the Australian Register of Therapeutic Goods (ARTG) for specific patients who need them. SAS is an individual patient access pathway, not a general market authorisation. Each approval covers one patient or a defined patient group, not ongoing commercial supply.

SAS is established under Part 3-2 of the Therapeutic Goods Act 1989 and is the primary mechanism by which patients in Australia can access unapproved devices when no suitable approved alternative exists or when waiting for ARTG approval is not clinically appropriate.

The Three SAS Categories

SAS Category A — Seriously ill patients

Category A applies where a patient is seriously ill with a condition from which they are likely to die or suffer serious permanent disability, and there is no other reasonable therapeutic alternative.

Under Category A:

The health practitioner does not need to obtain TGA approval before prescribing
The practitioner takes responsibility for the decision to use the unapproved good
The practitioner must notify the TGA within 28 days of first supplying the good to the patient
The good must be supplied through a licensed wholesaler or the manufacturer

Key point: Category A is self-authorising — the practitioner acts first and notifies afterwards. It is reserved for situations where the urgency of the patient's condition means prior TGA approval is not practical.

SAS Category B — Application to TGA required

Category B is the standard SAS pathway. The health practitioner or their institution applies to the TGA for approval before supplying the unapproved good to the patient.

Under Category B:

Application is submitted via the TGA's online SAS portal
The TGA assesses the application based on clinical need and available evidence
Approval is specific to the named patient and the specified product
TGA approval must be obtained before the device is supplied

Applications can be submitted by the treating practitioner or by an authorised delegate (such as a hospital pharmacist or regulatory affairs team).

👉 SAS Category B application — TGA

SAS Category C — Authorised supply

Category C allows the Secretary of the TGA to authorise certain classes of health practitioners to supply specified kinds of unapproved goods without needing individual patient approvals. This pathway is used where there is a pattern of legitimate clinical need for a product that has not yet been included in the ARTG.

Category C authorisations are product and practitioner-class specific. The TGA publishes the list of goods and practitioners covered by Category C authorisations.

👉 SAS Category C — TGA

What Can Be Accessed Under SAS

SAS covers unapproved therapeutic goods including:

Medical devices not included in the ARTG
Medical devices included in the ARTG for a different indication (off-label use in certain circumstances)
Newer generations or models of devices not yet on the ARTG

SAS does not authorise commercial supply — the device cannot be advertised or promoted for the unapproved use.

Supplying a device under SAS does not relieve the manufacturer or supplier of all regulatory obligations. The device must:

Still meet quality standards appropriate to the supply
Still be manufactured under appropriate quality management conditions
Be accompanied by adequate information for the prescriber

The importer or supplier of a device accessed under SAS may still need to hold an import licence under the Therapeutic Goods Act.

Reporting Adverse Events Under SAS

Adverse events involving devices accessed under SAS must still be reported to the TGA. The reporting obligations fall on:

The prescribing health practitioner
The sponsor or supplier where one exists

👉 Adverse event reporting

👉 Special Access Scheme — TGA\n👉 SAS Category B application — TGA\n👉 SAS Category C authorised supply — TGA\n👉 Part 3-2 — Therapeutic Goods Act 1989\n👉 Therapeutic Goods Regulations 1990

Overview​

The Three SAS Categories​

SAS Category A — Seriously ill patients​

SAS Category B — Application to TGA required​

SAS Category C — Authorised supply​

What Can Be Accessed Under SAS​

Sponsor and Manufacturer Obligations​

Reporting Adverse Events Under SAS​

👉 Special Access Scheme — TGA\n👉 SAS Category B application — TGA\n👉 SAS Category C authorised supply — TGA\n👉 Part 3-2 — Therapeutic Goods Act 1989\n👉 Therapeutic Goods Regulations 1990​

Related Pages​