What is an Authorised Prescriber

An Authorised Prescriber is allowed to supply therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) to a class of patients with a particular medical condition.

An Authorised Prescribers is allowed to supply the product directly to specified patients under their immediate care without requiring separate approval for individual patients.

Applying to become an Authorised Prescriber

There are two pathways to receive approval to be an authorised prescriber, either by established history of use or by the standard pathway.  Each are outlined below.

Established History of Use pathway

• Apply via TGA’s online system
• If therapeutic good isn’t standard of care at Austin health, submit TGA approval to:
  Drug & Therapeutics Committee for Drugs & Biologicals:
  New Technology Committee: For Medical Devices
• Submit: TGA & Austin Health Committee (if applicable) approval to research@austin.org.au

Standard pathway

Create Austin Health Cover Letter including

• the reason for the Authorised Prescriber application; and
• the name of each registered medical practitioner seeking endorsement to become an Authorised Prescriber.
• Supply Details - Provide details of exactly how the drug or device will be obtained. Authorised Prescribers are responsible for obtaining the unapproved therapeutic good.
• CV’s - Submit a latest curriculum vitae (CV) for each registered medical practitioner.
• Clinical Justification - The clinical justification for use of the unapproved good should provide sufficient evidence to demonstrate that this use is appropriate, considering the availability of any approved goods that may be suitable alternatives. Please ensure that clinical justification letter includes information about the following
  *the indication for which the therapeutic good will be used
  *the seriousness of the condition
  *the expected benefits of the proposed treatment versus its potential risks
  The justification should also address the circumstances where there are approved treatments for the same indication, specifically: why is the proposed unapproved good a more appropriate option than any approved available alternative? How the risk associated with the use of an unapproved good will be managed etc.
• Product Information - Provide product information or an investigator brochure including toxicology and safety information (If available).
• Consent form - Provide a copy of the template of the informed consent document to be provided to each patient receiving the unapproved therapeutic product. Please specify if M40 form will be used in place of consent form.

If therapeutic good isn’t standard of care at Austin Health, submit TGA approval to:

Drug & Therapeutics Committee: for Drugs & Biologicals
New Technology Committee: For Medical Devices

Submit cover letter and paperwork to Austin Health HREC via research@austin.org.au;

Once endorsed, submit all endorsements via TGA online Portal. 

Renewing Authorised Presciber status

To renew authorised presciber status please see TGA's guidelines under How do medical practitioners become Authorised Prescribers or renew authorisation

Responsibilities once TGA Approval is granted

• Provide TGA Approval to:

Pharmacy Department at Austin Health (for Investigational Medical Products);
New Technology Committee (For Investigational Medical Devices)

• Report adverse events and defects, following the guidelines on TGA website.  When reporting adverse events and defects send a copy of the report to research@austin.org.au
• Submit 6-monthly TGA Reports using Authorised Prescriber Scheme online system see: TGA online Portal.  Also send copies of reports to research@austin.org.au