Prepare a Special Access Scheme application or notification for an unapproved medicine
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- From the prescriber’s clinical summary and the product information, identify which pathway applies (Category A, B or C), complete the data for the TGA form, and list the clinical justification and supporting evidence the prescriber must provide.
- What the lawyer must review
- The lawyer or adviser confirms the pathway with the prescriber, checks the clinical justification is the prescriber’s own, confirms that for Category B approval is received before prescribing, and checks the patient’s informed consent is documented.
- Written for / version
- US
Open a jurisdiction version of this task to see which instruments apply: US
Who does what
| Role | What they do |
|---|---|
| Assistance | From the prescriber’s clinical summary and the product information, identify which pathway applies (Category A, B or C), complete the data for the TGA form, and list the clinical justification and supporting evidence the prescriber must provide. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Confirm patient health information goes only into a tool the practice has approved for health records, de-identified where the task allows, and that the output discloses no patient detail beyond what the recipient needs.
- Confirm the category against the patient’s circumstances and the product’s listing.
- Confirm the clinical justification is written by the prescriber.
- For Category B, confirm approval is held before the first prescription.
Sources
- TGA, Access unapproved therapeutic goods for individual patients: Special Access Scheme · 2026-10-18
These are suggested working checks. Confirm the required checking with the responsible lawyer before work starts; the checking approach does not establish permission to use AI.