Special access scheme

17 June 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 product 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. Patients are grouped into two categories under the scheme:

  • Category A patients are defined as 'persons 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 patients are all other patients that do not fit the Category A definition.
  • 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.
  • Special Access Scheme: Frequently Asked Questions
    The Special Access Scheme (SAS) refers to arrangements which provide for the importation and/or supply of an unapproved therapeutic good for a single patient, on a case-by-case basis
  • Special access scheme applications
    Notifications for Special Access Scheme Category A and applications under the Special Access Scheme Category B are made to the TGA by registered medical practitioners who are treating the patient
  • Supply of unapproved therapeutic goods under the Special Access Scheme
    Applicants should check with the supplier to see if they are prepared to supply the product before making an application
  • Access to unapproved therapeutic goods - Special Access Scheme
    Describes how to obtain approval for the supply of an unapproved therapeutic good in Australia under the Special Access Scheme and how to obtain the product once approval for supply has been given

Special access scheme forms

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

Please ensure each form is sent as a separate document.

These forms are available in both pdf and Microsoft Word formats. The pdf forms can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

How to access a pdf or Word document

Category A patients

Category B patients

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 special access scheme, see: Contact the TGA

Contact details
  • 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
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609