tga.gov.au Special Access Scheme Australia : Department of Health Therapeutic Goods Administration
Name of the Organization : Department of Health Therapeutic Goods Administration
Type of Facility : Special Access Scheme
Country : Australia
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Website : https://www.tga.gov.au/form/special-access-scheme
Category A Form : https://www.statusin.org/uploads/24526-categorya.pdf
Category B Form : https://www.statusin.org/uploads/24526-categoryb.pdf
Special Access Scheme :
Special access scheme applications :
** Applications under the Special Access Scheme (SAS) are made to the TGA by registered medical practitioners, preferably the treating doctor, who is best placed to determine the needs of the patient, including whether or not treatment with a particular product is required.
Related : National Disability Insurance Scheme Australia : www.statusin.org/24491.html
** It is expected that, in accordance with good medical practice, a medical practitioner will educate him/herself with all relevant and available information about any product before using it.
** Even if a patient asks to be treated with a particular unapproved product, a medical practitioner has the right to refuse to apply to obtain the product if he/she believes there is either insufficient clinical justification or no evidence to support the use of the product.
About the application process :
Category A patients :
** Medical practitioners can supply goods to 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.
** The medical practitioner completes the Category A ‘Authority to Supply’ form and sends it to the supplier of the product and a copy to the TGA.
** This provides the supplier with the legal authority to supply the product.
** Category A is a notification only. The TGA does not send out a letter of approval or acknowledgment.
Category B :
** Approval of an application to supply a 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).
The TGA requires the following information 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 |
** 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.
** If there is an urgent medical need for access to the product the application can be faxed to the TGA.
** On the bottom of your application please write ‘Urgent – Fax Response Asap’.
** For a limited number of products a phone approval can be given where there is an urgent medical need.
Send applications to :
Fax: 02 6232 8112
Post :
The Medical Officer,
SAS, Scientific Evaluation and Special Product Access Branch,
Therapeutic Goods Administration,
PO Box 100,
Woden ACT 2606