Special access scheme
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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.
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.
With the exception of drugs of abuse where the manufacture, possession, sale or use is prohibited by State or Territory law; any unapproved therapeutic good can potentially be supplied via the SAS.
- Special access scheme applications
Applications under the Special Access Scheme are made to the TGA by registered medical practitioners, preferably the treating doctor - 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
How to access a pdf or Word document
These forms are available in 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.
Category A patients
Category B patients
Consent to treatment and indemnity
- SAS - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (pdf,73kb)
- SAS - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (Microsoft Word,176kb)
Contact details for enquiries about the Special Access Scheme
If your enquiry is not about the special access scheme, see: Contact the TGA
| eps@tga.gov.au | |
| Phone |
|
| Fax | +61 2 6232 8112 |
| Postal address | The Medical Officer, SAS Office of Scientific Evaluation Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |
| Street address (for deliveries) |
Therapeutic Goods Administration 136 Narrabundah Lane Symonston ACT 2609 Australia |
Web page last updated: Thursday, 9 June 2011
URL: http://www.tga.gov.au/hp/access-sas.htm