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Special Access Scheme
The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient. Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described by us as 'unapproved'.
Medical practitioners that wish to access an 'unapproved' therapeutic good for a class of patients rather than an individual should visit the Authorised Prescribers web page.
If you are seeking to access medicinal cannabis products, please go to the Access to medicinal cannabis products web page.
SAS Online System
Submitting an application or notification through the SAS Online System will reduce processing times.
Submission by a health practitioner
SAS applications and notifications can only be submitted by certain registered health practitioners. Individual patients should discuss the suitability of using an 'unapproved' therapeutic good with a health practitioner.
'Unapproved' therapeutic goods have not been evaluated by us for quality, safety, efficacy or performance. Therefore, the prescribing health practitioner must consider the available evidence to support the use of the 'unapproved' product and any potential risks for the individual patient.
The responsibilities of the prescribing health practitioner include adhering to relevant standards of good medical practice and obtaining informed consent. The prescribing health practitioner also accepts responsibility for the use of an 'unapproved' therapeutic good and any associated adverse reactions.
There are three SAS pathways available to access 'unapproved' therapeutic goods. The prescribing health practitioner is responsible for deciding which pathway is most suitable for their patient.
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.
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.
A completed Category A form must be sent to the TGA:
- within 28 days after the medicine or biological is given to the person; or
- within 28 days after the use of the exempt medical device.
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.
Category B is an application pathway that can be accessed by health practitioners (usually medical or dental practitioners) if the patient does not fit the Category A definition and if the therapeutic good is not authorised for supply under the SAS Category C notification pathway.
Category B applications must be approved by TGA before the 'unapproved' product may be supplied to the patient:
- The application must be completed in full and include three patient identifiers, the patient diagnosis and indication, product details and prescriber details.
- The application requires a clinical justification for the use of the product, which should summarise:
- Details of relevant past treatments and procedures trialled or considered, including reasons why therapeutic goods currently included in the ARTG may not be the most appropriate treatment for the individual patient in the particular circumstance.
- An appraisal of the expected clinical benefits versus the potential risks of the proposed treatment
Supporting evidence may be requested by the TGA for some novel indications.
In some instances, evidence of specialist support from a practitioner with appropriate expertise may also be requested.
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.
A completed Category C form must be sent to the TGA within 28 days of the therapeutic goods being supplied.
There are separate lists for medicines, medical devices and biologicals. See the lists at Special Access Scheme rules.
Guidance and FAQs
- 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
- Access to medicinal cannabis products
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 SAS Online System is the preferred method of submission to reduce processing times for applicants. For commonly requested products, the timeframe between receipt of an online application by the TGA until a response is sent to the applicant, is typically 2 to 3 working days. This timeframe may be extended for products not previously requested under the SAS or where further information is required from the applicant.
Paper forms are available for use in exceptional circumstances, such as where the health practitioner is unable to access the SAS Online System.
Paper forms must be processed manually by our staff. Therefore, you must allow sufficient time (at least 2-7 business days) for paper applications to be processed.
Email forms to SAS@health.gov.au (preferred method) or fax to 02 6203 1105. Note: For email attachments, we prefer PDF and Microsoft Word documents.
To assist in timely processing, please ensure your submission is:
- Legible (typed submissions preferred)
- On the most current version of the form
- Completed in full with signature and date (provide 3 patient identifiers as well as the treating health practitioner's name and AHPRA number. A clinical justification is also required for all Category B applications)
Please ensure each form is sent as a separate document.