Special access scheme at a glance
Access to unapproved therapeutic goods
- 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. These arrangements are:
- Category A patients - medical practitioners can supply unapproved goods to some very seriously ill patients without the approval of the TGA as long as the medical practitioner notifies the TGA within 28 days, using a Category A Form.
- Category A patients are defined in the Therapeutic Goods legislation 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 - approval of an application to supply an unapproved product is required from a delegate in the TGA or a delegate outside the TGA (known as an external delegate). Approval by the TGA is given on a patient by patient basis to reflect the needs of different patients. Wherever possible, applications should be made in writing (preferably on a Category B form or an appropriate format that contains the same information).
- Applications are made by registered medical practitioners.
- The choice of classification of each patient lies with the treating medical practitioner. However, TGA is able to review, seek clarification and request information regarding the classification of patients under Category A.
- Information required by the TGA for applications involving Category B patients:
| The patient | |
|---|---|
| Patient details | Initials, Date of birth (or age), Sex, Patient ID or unit record number (if applicable), Diagnosis. Previous approval numbers for that patient, if applicable |
| Clinical justification | An outline of the seriousness of the patient's condition, details of past treatment and, if other approved treatments are available, justification for the use of the unapproved product in preference to those treatments. |
| The product | |
| Product details |
For unapproved medicines - active ingredient, trade name, dose form, supplier. For unapproved medical devices - name of device, supplier |
| Administration and monitoring regime | Dosage, route of administration, duration of treatment, details of proposed monitoring. |
| Efficacy/safety data | Efficacy and safety data sufficient to support the proposed use of the product. A copy of the reference articles from which the data have been obtained should be included. |
| The prescriber | |
| Details | Name, postal address, phone number, fax number |
Send applications to:
For unapproved medicines
| Phone | 02 6232 8111 |
|---|---|
| Fax | 02 6232 8112 |
| Postal | The Medical Officer, SAS Drug Safety and Evaluation Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 |
For unapproved medical devices
| Phone | 02 6232 8615 |
|---|---|
| Fax | 02 6232 8785 |
| Postal | Clinical Advisor Office of Devices, Blood and Tissues Therapeutic Goods Administration PO Box 100 Woden ACT 2606 |
Applicants should check with companies that they will agree to supply before making an application and what costs may be involved. Generally, the Commonwealth does not subsidise (through Pharmaceutical Benefits Scheme) the cost of unapproved products. Questions about the Pharmaceutical Benefits Scheme should be addressed to the Pharmaceutical Benefits Scheme Telephone Information Line 1800 020 613.