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Special Access Scheme

30 July 2018

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:

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.

Further information

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.

How to access a pdf or Word document

Category A

*Please note that for Schedule 8 medicinal cannabis products, the SASA notification form will need to be sent to the TGA prior to supply of the medicinal cannabis product to the patient. While SASA is a notification to TGA, NSW Health approval authorisation is still required for Schedule 8 products before prescribing can lawfully occur.

Category B

Category C

Place on the patient's file the completed and signed 'Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma'. Do not send to the TGA.

Importing controlled substances

Contact details for enquiries about the Special Access Scheme

If your enquiry is not about the SAS, see: Contact the TGA

Email: SAS@health.gov.au

Phone:

  • 1800 020 653
  • +61 2 6232 8644

Fax: +61 2 6232 8112

Post: SAS, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia

Street address (for deliveries): Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston ACT 2609, Australia