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
- SAS Category A form (pdf,56kb)
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,56kb)
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,50kb)
Information about the special access scheme
- Access to unapproved therapeutic goods - 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 - Access to unapproved therapeutic goods in Australia
A consolidation of the information about the mechanisms and regulations that allow patients to access unapproved medicines or medical devices in Australia