Special Access Scheme (SAS) in Australia: What the TGA Says About Unapproved Therapeutic Goods

Updated September 2026

The Therapeutic Goods Administration (TGA) has established the Special Access Scheme (SAS) to provide a pathway for Australian registered health practitioners to access certain therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) for individual patients in specific circumstances. (TGA, 2024)

The TGA’s Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods explains the requirements that apply when a health practitioner considers accessing an unapproved therapeutic good for an individual patient. The current guidance was published in October 2024 (Version 3.0). (TGA, 2024)

This article summarises the TGA’s guidance and is intended as general educational information. It does not replace the legislation, the TGA guidance, or advice from an appropriately registered health practitioner.

What is the Special Access Scheme?

Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported, supplied or exported in Australia.

Therapeutic goods that are not included in the ARTG are referred to by the TGA as unapproved therapeutic goods. These may include medicines, biologicals and medical devices.

The TGA states that unapproved therapeutic goods have not been assessed by the TGA for quality, safety, efficacy or performance in the same way as goods included in the ARTG. (TGA, 2024)

The SAS provides a pathway for Australian registered health practitioners to access an unapproved therapeutic good for an individual patient on a case-by-case basis, where the relevant requirements are met. (TGA, 2024)

The TGA also states that it encourages the use of therapeutic goods that are included in the ARTG, but recognises that there are circumstances in which a patient may require access to a therapeutic good that is not included in the ARTG. (TGA, 2024)

Can a patient apply for SAS access themselves?

No.

The TGA states that patients cannot apply directly to the TGA for access to an unapproved therapeutic good through the SAS.

Access through the SAS must be arranged by an appropriate Australian registered health practitioner. The relevant health practitioner is responsible for determining whether the SAS is appropriate and for submitting the required notification or application. (TGA, 2024)

This distinction is important because the SAS is a regulatory pathway for health practitioners. It is not an application system through which a member of the public can independently request an unapproved medicine from the TGA.

When can the SAS be used?

According to the TGA, the SAS can be used for individual patients where the prescriber reasonably believes that there are limited therapeutic options, having trialled or considered therapies included in the ARTG. (TGA, 2024)

The TGA gives examples of circumstances that may include:

• critically ill patients requiring urgent or early access to therapeutic goods not included in the ARTG;
• therapeutic goods that are available overseas but are not registered or supplied in Australia;
• therapeutic goods that were initially provided through a clinical trial after that trial has ended; and
• certain circumstances involving a shortage or discontinuation of a registered medicine.

The suitability of the SAS depends on the individual circumstances and the requirements of the relevant pathway. (TGA, 2024)

The SAS is therefore not described by the TGA as a general approval system for unapproved medicines. It is an access pathway that operates within specific legislative and clinical requirements.

The SAS does not mean the product is TGA-approved

This is one of the most important distinctions to understand.

A therapeutic good accessed through the SAS remains an unapproved therapeutic good. The fact that access has been permitted through an SAS pathway does not mean that the product has been included in the ARTG or assessed by the TGA as an approved therapeutic good.

The TGA specifically states that unapproved therapeutic goods have undergone little or no evaluation by the TGA for quality, safety, efficacy or performance. (TGA, 2024)

In simple terms:

SAS access ≠ ARTG approval.

The SAS is a regulatory mechanism that may allow access to an unapproved therapeutic good under defined circumstances.

What are the three SAS categories?

The TGA guidance describes three SAS pathways: (TGA, 2024)

SAS Category A — seriously ill patients

Category A is a notification pathway for individual patients who meet the TGA’s definition of being seriously ill.

For medicines and biologicals, the TGA defines a Category A patient as someone who is seriously ill with a condition from which death is reasonably likely within a matter of months, or where premature death is reasonably likely in the absence of early treatment.

Category A is a notification pathway, meaning prior TGA approval is not required. However, the required notification must be submitted within the timeframe specified by the TGA. For medicines and biologicals, the notification must generally be submitted within 28 days of the medicine or biological being given to the patient. (TGA, 2024)

SAS Category B — other patients or products

Category B is an application pathway for patients who do not meet the Category A definition and for products that are not available through Category C.

The treating health practitioner must have appropriate qualifications and/or expertise in the relevant condition and proposed use of the product.

Unlike Category A, the product must receive approval from a TGA Delegate before it can be supplied to the patient.

The application must include clinical justification supporting the proposed use for the particular patient. The TGA states that there is no guarantee that an application will be approved. (TGA, 2024)

SAS Category C — products with an established history of use

Category C is another notification pathway.

It applies to specified unapproved therapeutic goods that appear on the TGA’s Category C lists and meet the relevant requirements relating to the product, indication and type of health practitioner.

The prescribing health practitioner is responsible for ensuring that the therapeutic good is supplied in accordance with the applicable Category C rules. (TGA, 2024)

The Category C pathway therefore cannot simply be used for any unapproved product. The product, intended use and relevant health practitioner must correspond with the applicable legislative instrument. (TGA, 2024)

Who can prescribe under the SAS?

The TGA states that only appropriate Australian registered health practitioners can prescribe therapeutic goods under the SAS. (TGA, 2024)

The type of practitioner who can use a particular pathway depends on the pathway, product and relevant requirements.

The practitioner must have appropriate knowledge of the condition being treated and the unapproved product, and the intended use must fall within their scope of practice. For Category B applications, sufficient clinical justification must be provided to support use of the product for the particular patient. (TGA, 2024)

The TGA also states that patients cannot submit their own SAS notifications or applications. These must be completed and submitted by an appropriate Australian registered health practitioner, or another registered health practitioner acting on behalf of the prescriber where permitted. (TGA, 2024)

Non-health practitioners, sponsors and patients cannot draft or submit SAS forms on behalf of the prescribing practitioner. (TGA, 2024)

What should a practitioner consider before prescribing an unapproved therapeutic good?

The TGA guidance sets out a number of considerations that should occur before an unapproved therapeutic good is prescribed. (TGA, 2024)

1. Consider treatments included in the ARTG

Before prescribing an unapproved therapeutic good, the prescribing practitioner must consider relevant approved therapeutic goods.

The TGA states that relevant approved therapeutic goods should have been trialled or considered and found clinically unsuitable.

The practitioner must also consider whether the particular unapproved product is substantially similar to a product included in the ARTG. If it is substantially similar, the approved product must not currently be available for supply in Australia. (TGA, 2024)

2. Consider the evidence and potential risks

The prescribing practitioner must consider the evidence supporting the proposed use of the unapproved product as well as potential risks for the individual patient.

The TGA emphasises that unapproved therapeutic goods may have undergone little or no TGA evaluation for quality, safety, efficacy or performance. (TGA, 2024)

The prescribing practitioner therefore takes responsibility for the use of the unapproved therapeutic good and the resulting outcomes, including associated adverse reactions. (TGA, 2024)

The TGA also states that a treating practitioner may decline to prescribe an unapproved therapeutic good where they consider that there is insufficient clinical justification or evidence to support its use. (TGA, 2024)

3. Check that the product can actually be supplied

The TGA administers the SAS but is not responsible for the actual supply of the unapproved therapeutic good.

Before making an SAS submission, the health practitioner should establish that the intended sponsor or supplier is prepared to supply the product. (TGA, 2024)

The TGA notes that if the product cannot be sourced, the patient’s treatment may need to change. (TGA, 2024)

4. Select the appropriate SAS pathway

The prescribing health practitioner is responsible for determining which SAS pathway is appropriate.

The decision depends on factors including:

• the type of registered health practitioner;
• the patient’s circumstances;
• the therapeutic good; and
• the intended indication or purpose of use.

The TGA provides an interactive decision tool to assist health practitioners in determining whether the SAS is appropriate and, if so, which pathway may apply. (TGA, 2024)

What does the TGA say about informed consent?

Informed consent is an important part of the SAS process.

The TGA states that the prescribing health practitioner must obtain informed consent from the patient or the patient’s legal guardian before providing treatment. (TGA, 2024)

The patient must have sufficient information to make an informed decision about the proposed treatment. The TGA guidance describes informed consent as consent freely given on the basis of information about the potential risks and benefits that is sufficient to allow the person to decide whether to consent. (TGA, 2024)

The TGA states that informed consent should include appropriate information about matters such as: (TGA, 2024)

• the condition and its consequences;
• available treatment options;
• likelihood of recovery; and
• long-term prognosis.

For an unapproved therapeutic good, the TGA additionally expects the practitioner to explain that the product is not currently included in the ARTG and may not have been evaluated by the TGA for quality, safety, efficacy or performance. (TGA, 2024)

Patients should also be informed about:

• possible benefits;
• known risks and side effects;
• the possibility of unknown risks and side effects; and
• alternative approved treatments available in Australia.

Does SAS approval override state or territory laws?

No.

The TGA specifically states that SAS notification or approval does not override state or territory requirements that must be satisfied before a product can be lawfully obtained, prescribed or administered. (TGA, 2024)

The prescribing health practitioner is responsible for ensuring that applicable state or territory requirements are met. (TGA, 2024)

Additional requirements may apply to certain scheduled medicines, including requirements imposed by state or territory health departments or drug and poisons regulators. (TGA, 2024)

For prescription-only and controlled medicines, the TGA also notes that a valid prescription or order is necessary for a pharmacist to dispense medicines included in Schedule 4 or Schedule 8 of the Poisons Standard. (TGA, 2024)

What information is required for an SAS application?

The information required depends on the SAS pathway. (TGA, 2024)

For a Category B application, the TGA guidance states that clinical justification should explain why the particular product is being proposed for the individual patient. (TGA, 2024)

This can include relevant previous treatments or procedures that have been trialled or considered, why ARTG-included treatment may not be appropriate in the circumstances, and the expected clinical benefits compared with potential risks. Repeat applications should also include information about the patient’s response and any adverse effects experienced.

Applications can also require detailed information about the product, including its active ingredient, strength, dosage form, route of administration, dose, frequency and expected duration or quantity.

For new or experimental products, new indications or circumstances where the product has not previously been accessed through the SAS, clinical evidence relating to efficacy and safety may be required. The TGA guidance states that supporting reference articles may need to be attached to the application. (TGA, 2024)

What happens after an SAS application is submitted?

The process differs according to the SAS category. (TGA, 2024)

For Category A and Category C notifications, the TGA does not issue a letter of approval because these are notification pathways.

For Category B, the TGA considers the application before a decision is made. The TGA states that the typical timeframe between receiving a Category B application and providing a response is approximately two to three working days, although this can take longer where the product has not previously been requested under the SAS or further information is required. (TGA, 2024)

Category B decisions are made on a case-by-case basis.

The TGA states that important considerations include the needs of the patient, the status of the product and the expertise of the prescriber. The Delegate considers whether enough information has been provided to demonstrate that the unapproved therapeutic good has been considered as the most suitable treatment for that particular patient. (TGA, 2024)

Importantly, the TGA states that Category B approval cannot be granted retrospectively after an unapproved therapeutic good has already been supplied. (TGA, 2024)

Does the TGA supply the product?

No.

The TGA administers the regulatory pathway but is not involved in the actual supply of unapproved therapeutic goods. (TGA, 2024)

The health practitioner must consider the availability of the product and liaise with the intended sponsor or supplier as appropriate. (TGA, 2024)

What about adverse events and record keeping?

The SAS guidance also sets out responsibilities relating to adverse event reporting, product defects and record keeping. (TGA, 2024)

Conditions associated with Category B approval include responsibility for the outcome of the use of the unapproved therapeutic good and reporting relevant adverse events and defects to the TGA. (TGA, 2024)

The guidance also contains requirements concerning records, retention of documentation and information that may be requested by the TGA. (TGA, 2024)

What is the difference between SAS and off-label prescribing?

The TGA makes an important distinction between an unapproved therapeutic good and an approved therapeutic good being used off-label. (TGA, 2024)

Off-label use generally refers to using a therapeutic good for an indication or intended purpose that is not specified in its ARTG entry.

The TGA states that, generally, a health professional does not require an exemption, approval or authorisation from the TGA simply to use a therapeutic good off-label. Off-label prescribing is a clinical decision made at the discretion of the prescriber, who remains responsible for obtaining informed consent. (TGA, 2024)

The SAS is therefore primarily concerned with access to unapproved therapeutic goods, rather than being a general approval mechanism for off-label use of ARTG-included products.

What about compounded medicines?

The TGA guidance also distinguishes extemporaneous compounding from SAS access. (TGA, 2024)

Generally, medicines extemporaneously compounded by a pharmacist for a particular patient are exempt from the requirement to be included in the ARTG, subject to the applicable legislative requirements.

The TGA states that extemporaneous compounding by a pharmacist, other than certain circumstances such as medicinal cannabis, does not require additional approval or exemption under the SAS. (TGA, 2024)

Compounding therefore should not automatically be described as an SAS process. The applicable legal pathway depends on the circumstances, the product and the way it is manufactured and supplied.

What does the SAS mean for patients researching unapproved medicines?

The TGA’s guidance highlights several important distinctions. (TGA, 2024)

An unapproved therapeutic good is not the same thing as an ARTG-included therapeutic good.

An SAS notification or approval is not the same thing as TGA approval of the product.

A prescription is not the same thing as ARTG registration.

And the SAS is not a pathway that a patient can independently apply for. The process involves an appropriate registered health practitioner who is responsible for assessing the individual patient’s circumstances and meeting the relevant requirements. (TGA, 2024)

Key points from the TGA SAS guidance

(TGA, 2024)

Special Access Scheme and doctor-prescribed peptides

The SAS is relevant to the broader Australian framework for accessing certain unapproved therapeutic goods, which can include some medicines that are not included in the ARTG. (TGA, 2024)

However, whether a particular product can be accessed through the SAS cannot be determined simply because it is described as a “peptide”, because eligibility depends on the specific product, patient circumstances, intended use, prescribing practitioner and applicable regulatory pathway.

The TGA guidance places responsibility on the prescribing health practitioner to determine whether the relevant requirements are met, including consideration of available ARTG treatments, clinical evidence, risks, informed consent, scope of practice and the appropriate SAS category. (TGA, 2024)

The key takeaway

The Special Access Scheme is a regulatory access pathway for certain unapproved therapeutic goods. It does not turn an unapproved product into an ARTG-approved medicine.

The TGA guidance places significant responsibility on the prescribing health practitioner to assess the individual patient, consider available approved treatment options, consider the evidence and risks, obtain informed consent, select the correct SAS pathway and comply with applicable Commonwealth, state and territory requirements. (TGA, 2024)

For patients, the most important distinction is simple:

SAS access is a pathway to access an unapproved therapeutic good. It is not the same as TGA approval of that product.

Frequently asked questions

What does SAS stand for?

SAS stands for Special Access Scheme. It is a TGA pathway that allows appropriate Australian registered health practitioners to access certain unapproved therapeutic goods for individual patients when the relevant requirements are met. (TGA, 2024)

Can patients apply for SAS themselves?

No. Patients cannot submit their own SAS application or notification. The process must be arranged through an appropriate Australian registered health practitioner. (TGA, 2024)

Does SAS mean a medicine is TGA-approved?

No. An SAS pathway provides access to an unapproved therapeutic good under defined circumstances. It does not mean that the product has been included in the ARTG or assessed by the TGA as an approved therapeutic good. (TGA, 2024)

What is SAS Category B?

Category B is an application pathway for patients and products that do not fit Category A or Category C. A TGA Delegate must approve the application before the product can be supplied to the patient. (TGA, 2024)

Does SAS approval override state law?

No. SAS notification or approval does not override state or territory requirements relating to the lawful obtaining, prescribing or administration of a product. (TGA, 2024)

Is SAS the same as off-label prescribing?

No. The TGA distinguishes access to unapproved therapeutic goods through the SAS from off-label use of an ARTG-included therapeutic good. Generally, off-label use does not require TGA authorisation, although it remains a clinical decision for the prescriber and informed consent is required. (TGA, 2024)

Does SAS apply to every unapproved medicine?

Not automatically. The applicable pathway depends on factors including the product, patient circumstances, intended use and type of registered health practitioner. Certain products and substances are excluded or subject to additional requirements. (TGA, 2024)

Official TGA source

Therapeutic Goods Administration (2024). Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods, Version 3.0, October 2024. (TGA, 2024)

• Read the full TGA Special Access Scheme guidance (PDF)
• TGA: Special Access Scheme – guidance for health practitioners
• TGA: Access to unapproved therapeutic goods – Special Access Scheme

Source: Therapeutic Goods Administration (TGA), Australian Government.

Related reading

• What Is a Schedule 4 Medicine in Australia?
• What Is the ARTG? Understanding Australia’s Register of Therapeutic Goods
• What Is a Compounded Medicine? Understanding Pharmaceutical Compounding in Australia
• Approved vs Unapproved Therapeutic Goods: What Is the Difference?
• Doctor-Prescribed Peptides in Australia: What the New AHPRA Guidance Says