Special access scheme
The Special Access Scheme 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.
Special access scheme forms
These 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.
- SAS Category A form (pdf,95kb)
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". - SAS Category B form (pdf,77kb)
Category B patients are all other patients that do not fit the Category A definition. - SAS - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (pdf,60kb)
Information about the special access scheme
- Access to unapproved therapeutic goods via the Special Access Scheme
Describes how to obtain approval for the supply of an unapproved therapeutic good under the Special Access Scheme and how to obtain the product once approval for supply has been given - Special Access Scheme at a glance
The Special Access Scheme 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 - Frequently asked questions - Special Access Scheme
Answers to frequently asked questions about the Special Access Scheme - Human research ethics committees and the therapeutic goods legislation
Describes the role of HRECs in relation to the supply of unapproved therapeutic goods in connection with the operation of the Clinical Trial Notification Scheme, the Clinical Trial Exemption Scheme, the Special Access Scheme, and in the approval of Authorised Prescribers