---
title: "Prepare a Special Access Scheme application or notification for an unapproved medicine"
url: "https://ailawframework.com/practice/health-and-medical-law/prepare-a-special-access-scheme-application-or-notification-for-an-unapp"
type: "task"
site: "AI Law Framework"
id: "A32-R20261018-6"
practice_area: "Health & Medical Law"
tier: "yellow"
lawyer_review: "required"
last_reviewed: "2026-10-22"
---

# Prepare a Special Access Scheme application or notification for an unapproved medicine

> 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…

Canonical page: https://ailawframework.com/practice/health-and-medical-law/prepare-a-special-access-scheme-application-or-notification-for-an-unapp  
Last reviewed: 2026-10-22

Site index for agents: https://ailawframework.com/llms.txt

## Key facts

| Fact | Value |
| --- | --- |
| Practice area | [Health & Medical Law](https://ailawframework.com/practice/health-and-medical-law.md) |
| Human involvement | Yellow: Lawyer and AI draft together |
| 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 / versions | 1 jurisdiction versions below |

## Checking plan

**Source-by-source verification**

Trace relied-on content to independent sources and check for relevant material the output has missed.

- What the AI does: 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 does: 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.
- Who reviews: Responsible lawyer with competence in the matter
- Basis: Practical workflow informed by the linked primary sources; the traffic light and working checks are editorial guidance, not a court classification.
- Why: The level reflects what the work is, the consequence of an error, and how much of the output the lawyer must independently re-derive.

## Checks the lawyer makes

1. 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.
2. Confirm the category against the patient’s circumstances and the product’s listing.
3. Confirm the clinical justification is written by the prescriber.
4. For Category B, confirm approval is held before the first prescription.

## Notes

- 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.

## Sources

- [TGA, Access unapproved therapeutic goods for individual patients: Special Access Scheme](https://www.tga.gov.au/business-services/special-access-scheme-and-authorised-prescriber-online-system/access-unapproved-therapeutic-goods-individual-patients-special-access-scheme) (checked 2026-10-18)

## Jurisdiction versions

| Jurisdiction | Level |
| --- | --- |
| [United States](https://ailawframework.com/practice/health-and-medical-law/prepare-a-special-access-scheme-application-or-notification-for-an-unapp/united-states.md) | Red |

*Practice guidance for planning and review. Confirm current primary sources and the requirements of the actual matter. This is general information, not legal advice.*