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Special Access Scheme
This information is for health practitioners who wish to access therapeutic goods that are not in the Australian Register of Therapeutic Goods (ARTG) and are not otherwise exempt from being in the ARTG. We describe these therapeutic goods as 'unapproved'. Those using unapproved therapeutic goods have responsibilities, which include adhering to relevant standards of good medical practice.
If you need to access an unapproved therapeutic good for your patient then you may use the Special Access Scheme (SAS). SAS is intended for exceptional clinical circumstances.
Therapeutic goods entered in the ARTG have been evaluated by TGA for quality, safety, efficacy and performance. Therefore you are expected to have considered all available treatment options included in the ARTG prior to making an application or notification under the SAS to access an unapproved therapeutic good.
Find out more about the three pathways available under SAS.
If you are seeking to access medicinal cannabis products, please go to Access to medicinal cannabis products.
Three pathways under the Special Access Scheme
There are three SAS pathways that a health practitioner may use to access an unapproved therapeutic good for an individual patient on a case-by-case basis.
Please note that you will not receive acknowledgement from us when you make a SAS Category A or Category C notification. These notification pathways do not require approval from the TGA.
SAS category A: notification for a patient defined as seriously ill
Category A is a notification pathway that may be accessed by a prescribing medical practitioner or by a health practitioner on behalf of a prescribing medical practitioner.
Category A patients are defined as being seriously ill if:
- For medicines and biologicals, they have a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
- For medical devices, they have a condition that is reasonably likely to lead to the person's death within less than a year or, without early treatment, to the person's premature death.
Substances in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by State or Territory law) cannot be accessed through SAS Category A.
SAS category B: application pathway
Category B is an application pathway that can be accessed by health practitioners (usually medical or dental practitioners) if patients do not fit the Category A definition and if the good is not authorised for supply under the SAS Category C notification pathway.
Category B applications must be reviewed and approved by TGA before the unapproved product may be accessed and supplied to the patient:
- The application must be completed in full and include the patient diagnosis and indication for which the product is sought.
- The application requires a thorough clinical justification for the use of the product, which includes the seriousness of the condition, details of previous treatment and reasons why a therapeutic good currently included in the ARTG cannot be used for the treatment of the individual patient in the particular circumstance.
- The application must include sufficient safety and efficacy data to support the proposed use of the product. This may include references to clinical trial results and published peer-reviewed data, or evidence that the product has been approved for an equivalent indication by a national regulatory body with comparable regulatory requirements.
- The application should include details of intended monitoring for adverse events and patient response to treatment.
SAS category C: notification of use of specified therapeutic goods
Category C is a notification pathway that allows certain types of health practitioners to supply therapeutic goods that are deemed to have an established history of use. These goods are specified in a list along with their indications and the type of health practitioner authorised to supply these products for the respective indications.
There are separate lists for medicines, medical devices and biologicals:
- Medicines: Therapeutic Goods (Authorised Supply of Medicines) Rules 2019
- Medical Devices: Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules March 2018
- Biologicals: Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules April 2018
Special Access Scheme Online System
On Monday, 30 July 2018 an online system was introduced to enable the electronic submission of SAS applications and notifications to the TGA. Use of this online system will reduce administrative burden on health practitioners and allow users to manage the SAS applications and notifications they submit to the TGA.
Visit the Special Access Scheme Online System page to find out more.
- SAS guidance for use of online system
Users of the SAS online system should refer to the user guidance which provides information on the system's features and functionality.
- SAS guidance tool for access to unapproved therapeutic goods
As a compliance aid, the guidance tool assists health practitioners in determining the most appropriate pathway (if any) to access unapproved therapeutic goods
- SAS guidance for health practitioners and sponsors
Guidance for health practitioners and sponsors outlining the various access pathways and their regulatory obligations when accessing and supplying unapproved therapeutic goods
- SAS guidance on medicinal cannabis
Information relevant to accessing unapproved medicinal cannabis products
- SAS frequently asked questions
Questions and answers for consumers, health practitioners and sponsors relating to the SAS
- Access to unapproved therapeutic goods
The Australian Medical Association (AMA) and Pharmaceutical Society of Australia (PSA) are hosting Continuous Professional Development (CPD) modules on the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme. These modules also include information on access to medicinal cannabis.
Forms for the Special Access Scheme
Email forms to SAS@health.gov.au (preferred method) or fax to 02 6232 8112. Note: For email attachments, we prefer PDF and Microsoft Word documents.
Please ensure each form is sent as a separate document.