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Pharmacy Applications

​The CCLHD pharmacy department should be consulted for any applications under the following Therapeutic Goods Administration (TGA) schemes;

External page link Special Access Scheme (SAS) A or B *

External page link Authorised prescriber *

*These applications must be authorised by the Pharmacy Department prior to lodgement with the TGA.

Special Access Scheme A or B

The Special Access Scheme (SAS) A or B refers to arrangements which provide for the import and/or supply of unapproved therapeutic goods, 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 All other patients who do not fit into 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.

Generally, for commonly requested products the TGA has a turnaround time of two 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 directly to the TGA, if the applicant places ‘URGENT: FAX RESPONSE ASAP’ on the bottom of the application. Please note that this is only after sign-off by the relevant Pharmacy Department.

In addition, for a limited number of products telephone approval can be given where there is an urgent medical need.

Apply to the Special Access Scheme

External page link Special access schemeThe submission details after pharmacy authorisation* are as follows:

Fax: 02 6232 8112

Post:

The Medical Officer
SAS, Office of Scientific Evaluation
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

* Please note SAS A and B applications must be authorised by the Pharmacy Department prior to lodgement with the TGA.

Authorised prescriber

Applications can be made via the Therapeutic Goods Administration (TGA) Authorised prescriber schemein circumstances where patients may require access to medicines or medical devices that have not yet been approved for supply by the TGA in Australia.

In these circumstances a medical practitioner may be granted authority to become an authorised prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.

The medical practitioner becomes an ‘authorised prescriber’ and can prescribe that product for that condition (also known as the ‘indication’) to individual patients in their immediate care without further TGA approval.

To be an authorised prescriber the medical practitioner must:

  • have the training and expertise appropriate for the condition being treated and the proposed use of the product
  • be able to best determine the needs of the patient
  • demonstrate the ability to monitor the outcome of the therapy
  • have their application endorsed by a Human Research Ethics Committee (HREC).

An authorised prescriber is allowed to supply the product directly to specified patients under their immediate care and not to other practitioners who prescribe/administer the product. Use of the product under an authorisation must be at all times in line with the conditions specified in the authorisation.

Once a medical practitioner becomes an ‘authorised prescriber’ they do not need to notify the TGA when they are prescribing the unapproved product, however they must report to the TGA the number of patients treated on a six monthly basis.

The submission details after Pharmacy and HREC endorsement* are as follows:

Fax: 02 6232 8112

Post:

The Medical Officer
Experimental Products Section
Office of Scientific Evaluation
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

If you intend on submitting an authorised prescriber application please contact the pharmacy department on 02 4320 3366 to notify of your intent to submit. The pharmacy department will liaise with the Research Office who will arrange review and endorsement by an appropriate HREC.

* Please note that Authorised Prescriber applications must be endorsed by the relevant CCLHD Pharmacy Department and an accredited NSW Health Human Research Ethics Committee (HREC) prior to lodgement with the TGA.

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