Accessing unapproved therapeutic products

Submit a cover letter that includes the following information:

• The reason for the Authorised Prescriber application
• The name of each registered medical practitioner seeking endorsement to become an Authorised Prescriber

Provide details of exactly how the drug or device will be obtained/supplied.

Will an agreement between RMH and the provider be required? If so, provide an electronic copy of the agreement from the supplier for review and execution by the Office for Research.

Authorised Prescribers are responsible for obtaining the unapproved therapeutic good. If the Authorised Prescriber is an employee of RMH, these arrangements will be made by RMH on behalf of the approved Authorised Prescriber.

Complete the Authorised Prescriber Site Specific Authorisation form which requires Head of Department or Divisional Director signoff.

An Authorised Prescriber applicant must not approve their own authorised prescriber requests on behalf of their department. If an Authorised Prescriber applicant is also Head of Department approval must be sought from the person to whom the Head of Department is responsible (for example, Divisional Director).

Submit a copy of the most recent curriculum vitae (CV) for each registered medical practitioner.

Download the Authorised Prescriber Application form from the TGA website – complete and submit one form for each medical practitioner.

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.

Specifically, provide information on:

• The indication for which the good will be used
• The seriousness of the condition
• The expected benefits of the proposed treatment versus its potential risks
• It should also address the circumstances where there are approved treatments for the same indication, specifically:
  • Have they been attempted?
  • Will they be attempted before supplying the unapproved good?
  • Why are they inappropriate?
  • 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
• The monitoring that will be undertaken
• The process for investigating and reporting adverse events

Provide product information or an investigator brochure including toxicology and safety information.

Provide a copy of the template of the informed consent document to be provided to each patient receiving the unapproved therapeutic product. Often the template will be provided by the supplier of the unapproved therapeutic product. The Authorised Prescriber must obtain the written informed consent of each patient for whom they prescribe the unapproved product. This consent form must be in plain and simple English and include statements about the following:

• That the TGA has not evaluated the unapproved good’s safety, quality and efficacy
• That the product is not approved for marketing in Australia
• The possible benefits of treatment and any risks and side effects that are known
• The possibility of unknown risks and side effects
• Any alternative treatments using approved products that are available

For the RMH HREC to endorse your application you must:

• Have an appointment at the RMH, or
• Have an appointment at Western Health, or
• Your practice must be located within the geographical area that the RMH HREC serves.

Complete the Authorised Prescriber Fee Payment Form.

Fees are payable upfront at the time of initial submission to the Office for Research.

Submit both one hard copy and one electronic copy to the Office for Research.

• Deliver a hardcopy to:

  Manager, Human Research Ethics Committee
  Office for Research
  Level 2 South West, 300 Grattan Street
  Parkville VIC 3050

• Email the electronic copy to ethics@mh.org.au and include "Authorised Prescriber Request" in the subject line.