Special access scheme
The SAS Category A and Category B forms were amended in March 2014 to include a privacy statement to be compliant with Australian Privacy Principle 5 (notification of the collection and disclosure of privacy information) as part of the Privacy Amendment (Enhancing Privacy Protection) Act 2012. Further amendments were made including formatting, a request for a pharmacy fax number and amendment of the email address (SAS@tga.gov.au).
In April 2014, acting on advice and feedback, the SAS forms have been reformatted to include a statement regarding provision of false or misleading information as being considered an offence under the Criminal Act, and an additional space for providing details on the strength of medicine. The sponsors address on the Category A form has also been removed.
The 'Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma' form has been amended to advise that it is no longer required to be submitted to the TGA, however this form should be retained on the patient's file.
The April 2014 forms are now the current versions and must be used for any new applications or notifications.
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.
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
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.
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.
- SAS - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (pdf,81kb)
- SAS - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (Microsoft Word,162kb)
If your enquiry is not about the special access scheme, see: Contact the TGA
|Fax||+61 2 6232 8112|
|Postal address||The Medical Officer, SAS
Office of Scientific Evaluation
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
|Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Web page last updated: Wednesday, 16 April 2014