Special Access Scheme

3 July 2017

Most therapeutic goods are required to undergo an evaluation for quality safety and efficacy and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

In recognition that there are circumstances where patients need access to therapeutic goods that are not on the ARTG, the TGA manages the Special Access Scheme (SAS) and other programs.

If you are seeking to access medicinal cannabis products please visit the 'Access to medicinal cannabis products' section of our website.

About the Special Access Scheme

The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Three pathways exist under the scheme, which can be utilised by health practitioners, and they are categorised as follows:

  • Category A is a notification pathway which can only be accessed by medical practitioners for patients who are seriously ill with 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.
  • Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from TGA is required before the good may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.
  • Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use 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 list for medicines, medical devices and biologicals, as follows:

Any unapproved therapeutic good can potentially be supplied via the SAS except for drugs of abuse in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by State or Territory law) which cannot be accessed through the SAS Category A process.

For more information on access to medicinal cannabis products please visit our Access to medicinal cannabis products web page.

Special Access Scheme forms

Forms can be emailed to SAS@health.gov.au (preferred method) or faxed to 02 6232 8112. Note: For email attachments, PDF and Microsoft Word documents are preferred.

Please ensure each form is sent as a separate document.

How to access a pdf or Word document

Category A

Category B

Category C

Consent to treatment and indemnity

Note: Do not send the 'Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma' to the TGA. This should be kept on the patient's file.

Importing controlled substances

Contact details for enquiries about the Special Access Scheme

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

Contact details
Email
Phone
  • 1800 020 653
  • +61 2 6232 8644
Fax +61 2 6232 8112
Postal address The Medical Officer, 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