Authorised Prescribers
Overview
The Authorised Prescriber (AP) pathway allows medical practitioners to obtain a standing authorisation from the TGA to prescribe a specific unapproved therapeutic good — including medical devices — to multiple patients with a particular medical condition. Unlike SAS Category B, which requires a separate application for each patient, the Authorised Prescriber pathway provides a single authorisation that covers ongoing prescribing for a defined patient population.
This pathway is appropriate where a practitioner has an ongoing, legitimate clinical need to use a specific unapproved device for a recurring condition in their patient population and it would be impractical to submit individual SAS applications each time.
How the Authorised Prescriber Pathway Works
Step 1 — Apply to the TGA A medical practitioner applies to the TGA for Authorised Prescriber status for a specific unapproved good and a defined medical condition. The application requires:
- Clinical justification for why the unapproved good is needed
- Evidence of the product's safety and efficacy for the proposed use
- Endorsement from a relevant specialist college or an approved Human Research Ethics Committee (HREC)
Step 2 — TGA assessment The TGA assesses the application and, if satisfied, grants Authorised Prescriber status. Authorisation is:
- Specific to the individual practitioner (not transferable)
- Specific to the product (trade name, model, or category as approved)
- Specific to the medical condition or patient population
- Subject to ongoing conditions including adverse event reporting and periodic review
Step 3 — Ongoing prescribing Once authorised, the practitioner can prescribe the specified unapproved good to their patients without submitting individual SAS applications. They must comply with the conditions of their authorisation.
Conditions of Authorised Prescriber Status
Authorised prescribers must:
- Notify the TGA of the number of patients treated under the authorisation annually
- Report adverse events involving the unapproved good to the TGA
- Ensure patients are informed that the product is unapproved and consent to its use
- Maintain records of patients treated under the authorisation
- Comply with any other conditions specified in the authorisation
Endorsement Requirement
Before applying, the practitioner must obtain endorsement from either:
- A relevant specialist medical college (e.g., the Royal Australasian College of Surgeons, the Cardiac Society of Australia and New Zealand), or
- An approved Human Research Ethics Committee (HREC)
The endorsing body assesses whether the proposed use is clinically appropriate and whether the evidence base for the product justifies its use outside the ARTG framework.
Difference Between SAS and Authorised Prescriber
| SAS Category B | Authorised Prescriber | |
|---|---|---|
| Application required | Per patient | Once per product/condition |
| Suitable when | Occasional, patient-specific need | Ongoing, recurring need for same product |
| Patient specificity | Named patient | Defined condition/population |
| Specialist endorsement | Not required | Required |
| Reporting | Per adverse event | Annual patient numbers + adverse events |
Limitations
The Authorised Prescriber pathway does not:
- Authorise commercial supply or distribution of the unapproved good
- Allow advertising or promotion of the unapproved use
- Transfer to other practitioners
- cover goods used as part of a clinical trial (which requires separate CTN/CTA approval)
Official Sources
- Authorised prescribers — TGA
- Section 19 — Therapeutic Goods Act 1989
- Guidance for authorised prescribers — TGA