Frequently asked questions - Special access scheme
Access to unapproved therapeutic goods
What therapeutic goods are available through SAS?
With the exception of drugs of abuse where the manufacture, possession, sale or use is prohibited by State or Territory law, all unapproved therapeutic goods can potentially be supplied via the SAS.
How long does it take to process an application?
| Category A | is a notification only. TGA does not send out a letter of acknowledgment. The medical practitioner completes the Category A "Authority to Supply" form and sends it to the sponsor of the product and a copy to the TGA. This provides the sponsor with the legal authority to supply the product. |
| Category B | generally, for commonly requested products TGA has a turnaround time of 2 working days from time of receipt of the application until a response is prepared and mailed. Applications for products not previously requested under the SAS may take longer. |
Under this circumstance, a phone request can be made. Alternatively, the application can be faxed to the TGA. On the bottom of your application please write: 'FAX RESPONSE ASAP'.
NOTE: phone requests should be reserved for cases where there is an urgent medical need for access to the product.
I wish to bring a product into Australia for commercial supply. Can I do this under the SAS?
No. The SAS is a mechanism by which individual named patients can access an unapproved therapeutic good through their medical practitioner. Therapeutic goods intended for commercial supply in Australia are required to undergo an evaluation for quality safety and efficacy prior to being allowed on the market. The various mechanisms for supply of unapproved products are intended to be temporary measures for supply, pending general marketing approval of the product. Unfettered access to unapproved products amounts to defacto marketing and would remove any incentive for a sponsor to seek marketing approval for their products.
In keeping with its overall charter, the TGA has a responsibility to encourage at all times the availability of approved (evaluated) products.
My doctor does not know anything about this product. Can I write my own SAS application?
No. A doctor must write an SAS application and must be able to justify on medical grounds why his/her patient requires the unapproved product.
The treating doctor is best placed to determine the needs of the patient, including whether or not treatment with a particular unapproved product is required. It is expected that, in accordance with good medical practice, a medical practitioner will educate him/herself with all relevant and available information about an unapproved product before using it.
It is also important to note that a medical practitioner has the right to decline to prescribe an unapproved product if he/she believes there is either insufficient clinical justification or no evidence to support the use of the product.
How do I get the product once the TGA has given approval?
If the product is available from a supplier in Australia, you should contact the supplier (sponsor) to organise supply. Within an institution supply of a medicine can usually be arranged by the pharmacy department. The supplier will require authorisation to release the product. In the case of supply for a category A patient, the completed 'Authority to Supply' form acts as the authorisation. For category B patients, an approval number is issued by the TGA and will appear in an approval letter sent to the requesting doctor by the TGA. This number must be quoted in all correspondence with the sponsor.
If the product is not available from an Australian sponsor, the requesting doctor will need to find an overseas source. The product will then need to be imported from that supplier. This can be done by the doctor, a pharmacist, hospital, by the patient or by a licensed importer. When seeking to arrange importation of an unapproved medicine, it is important to check whether it is controlled under Customs (Prohibited Import) Regulations, in which case it cannot be imported without an import permit. A list of controlled substances can be found on the Australian Government Department of Health and Ageing website <http://www.health.gov.au/internet/main/publishing.nsf/Content/list-of-drug-substances-requiring-import-and-or-export-authorisations>. When approval is given under the SAS for supply of a controlled medicine, TGA will automatically issue an import permit.
Does TGA approval (or notification of Category A use) automatically mean I can access the product?
No. Sponsors are under no obligation to supply an unapproved product merely because the TGA has given an approval. Before submitting an application to the TGA, doctors should check with the sponsor to see if they are prepared to supply the product. In addition, TGA approval does not override any State/Territory requirements that need to be met before the product can be supplied lawfully. These requirements can be product specific and applicants need to check these with their State/Territory health department. Contact details can be found in local telephone books.