In this section
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.
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:
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:
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: