You may have a patient who needs access to medicines or medical devices that have not been approved by the Therapeutic Goods Administration (TGA). If this is the case, you can investigate becoming an Authorised Prescriber.

Being registered as an Authorised Prescriber enables a medical practitioner to prescribe an unapproved therapeutic good to specific people with a particular medical condition. As an Authorised Prescriber, you are allowed to supply the good directly to specified patients under your immediate care. You cannot supply it to other practitioners. 

An HREC needs to endorse your authorised prescriber application before you submit it to the TGA. The RCH HREC is able to review applications and provide endorsement to support submissions to the TGA.

Submission Process to the TGA

1. Application to become an Authorised Prescriber 

The medical practitioner must make an individual application to the Therapeutic Goods Administration (TGA). They need to include a letter of endorsement provided by a registered HREC (see TGA Agreement to Treatment Directions). The medical practitioner needs to complete the following steps to become an Authorised Prescriber:

1. Review the TGA Authorised Prescriber website to ensure you are familiar with the regulations associated with becoming an Authorised Prescriber, and to complete the Authorised Prescriber forms.
2. If the medical practitioner is an employee of RCH, you need to get approval from the Drug Usage Committee (DUC) if you are making an application for a drug, or the New technology & Clinical Practice Committee (NTCPC) if you are making an application for a medical device.
3. Forward a complete copy TGA Authorised Prescriber application, including the relevant committee’s signed endorsement, to the RCH HREC for review and endorsement. The endorsement letter provided to the medical practitioner will be signed by the RCH HREC Chair, and must contain the following information:  
   • the name of the medical practitioner being endorsed
   • the drug or device and indication for which endorsement has been given
   • the site(s) at which use is covered by the endorsement, and
   • any conditions the ethics committee has imposed on the endorsement. 
4. The application is lodged by the Medical Practitioner to the TGA. 

2. Renewal of Authorised Prescriber status

If the Authorised Prescriber wishes to extend the period of TGA approval the medical practitioner must make a formal request to the RCH HREC and supply the following information:

• The details of utilisation of the product since date of previous approval, and

• Any details relating to any adverse events relating to utilization of the product since date of previous approval.

The Therapeutic Goods Administration may give notice of revocation of this authorisation at any time.  This authorisation is valid only until revoked or until a product with the same active ingredient or in the same therapeutic class is approved in Australia, whichever is the earlier.

3. Responsibilities of Authorised Prescribers 

The responsibilities of an Authorised Prescriber are detailed in the document Access to Unapproved Therapeutic Goods - Authorised Prescribers and include:  

• ensure the NTCPC or the RCH Pharmacy Department is provided with a copy of the TGA approval for Authorised Prescriber status
• ensuring the patient has provided appropriate written informed consent prior to treatment
• report any adverse events associated with the use of the product to the TGA, the DUC or the NTCP and comply with reporting requirements of the TGA
• provide an annual report to the relevant body relating to utilization of the products / medicines (for RCH Authorised Prescribers, this is the  DUC or the NTCPC.

Submission Process for HREC Endorsement Letter for new applications and renewals

Please email the REG Office the following:

• Cover letter detailing: product details, e.g. dose/capsule, etc, indication, age and prescriber names.
• DUC/NTPCP application
• DUC/NTPCP approval letter
• Product information Sheet