Special Access Scheme
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 included on the ARTG, the TGA manages the Special Access Scheme (SAS) and other access pathways.
If you are seeking to access medicinal cannabis products 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. Three pathways which can be utilised by health practitioners exist under the scheme, and they are categorised as follows:
- Category A is a notification pathway which can be accessed by a prescribing medical practitioner or a health practitioner on behalf of a prescribing medical practitioner for patients 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 is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from TGA is required before the good may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.
- Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products for the respective indications. There are separate list for medicines, medical devices and biologicals, as follows:
Any unapproved therapeutic good can potentially be supplied via the SAS except for goods included in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by State or Territory law) which cannot be accessed through the SAS Category A process.
- SAS guidance tool for access to unapproved therapeutic goods
As a compliance aid, the guidance tool assists health practitioners in determining the most appropriate pathway (if any) to access unapproved therapeutic goods
- SAS guidance for health practitioners and sponsors
Guidance for health practitioners and sponsors outlining the various access pathways and their regulatory obligations when accessing and supplying unapproved therapeutic goods
- SAS frequently asked questions
Questions and answers for consumers, health practitioners and sponsors relating to the SAS
Special Access Scheme forms
Forms can be emailed to SAS@health.gov.au (preferred method) or faxed to 02 6232 8112. Note: For email attachments, PDF and Microsoft Word documents are preferred.
Please ensure each form is sent as a separate document.
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,85kb)
- SAS - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (Microsoft Word,130kb)
Importing controlled substances
- Importing narcotic, psychotropic and precursor substances (Special Access Scheme only) (form and guidance)
Contact details for enquiries about the Special Access Scheme
If your enquiry is not about the SAS, see: Contact the TGA
|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
|Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609