An AUST L listing is how most low-risk supplements reach the Australian market. The application itself is lodged through the TGA's own online services, and it asks you to certify things. Behind every "yes, I hold this" sits a body of work: the claims you intend to make, the evidence behind each one, the label, and the records that say who affirmed what and when.
This article walks through what that work actually produces. It uses the documents in a Regulave submission pack, because each one exists to answer a question an application will ask of you.
The ten documents, in plain words
1. Pack Status. The pack's own cover page: every open item in one place, read first. It is where you can see, at a glance, what is finished and what still needs you.
2. Sponsor & Product Summary. Who you are and what the product is: the sponsor details, the product, its form, its ingredients and the claims you intend to make, gathered once so every other document agrees with it.
3. Indications & Claims Schedule. Each claim you intend to make, mapped to the Therapeutic Goods (Permissible Indications) Determination, the list listed medicines must choose their claims from. It shows the source's currency date.
4. Evidence Matrix. For each intended claim: the type of evidence it needs, the minimum the TGA's evidence guidelines set for that type, and where the pack holds it. It is the working record of whether each claim is supported.
5. Literature Search Log. The papers located for each claim, with the search that found each one. It retrieves and describes; it does not appraise.
6. Literature Search Strategy. How the searching was done: every query as it was run, what it returned, what was kept and what was refused, and whether re-running it would give the same result.
7. Scientific Evidence Record. The record kept as evidence: for each claim, each included paper with its citation, its study design in the paper's own words, the population and the intervention.
8. Label Compliance (TGO 92). The mandatory and warning label requirements for a listed medicine, drawn from the labelling order, your matched claims and your ingredients.
9. Certification & Sign-off Record. The accountability record: every certification statement, who affirmed it, in what position, and when.
10. TBS Lodgement Companion. A companion to the TGA's online application. The live TGA screens govern, and field order and wording may vary, so it is a guide to what you will be asked rather than a copy of the screens.
What makes a pack trustworthy
A document is only as useful as your ability to check it. Three habits run through every document in the pack.
- Every statement traces to its source. A claim cites the determination it comes from. A label requirement cites the order that sets it, and a paper cites its own record. Nothing is guessed, and nothing is invented.
- Every claim is matched to real papers. Each intended claim is searched, and the papers found are listed with the search that found them, so you can see why each one is there.
- The record says what it does not know. Where evidence is thin, missing or not yet held, the pack says so in plain words rather than filling the gap.
The independent-reviewer step
Before a pack reaches you, a second, independent AI reviewer reads it looking for weaknesses: a claim whose papers do not really address it, an ingredient whose evidence is thin, a gap between two documents.
Its challenges are not taken on trust. Each one becomes a search instruction and is re-asked of the literature by the pack's own deterministic tools. The pack changes only when that search confirms the challenge. The reviewer proposes; the evidence decides.
This is the step that makes the difference. A pack that has already been attacked, with its gaps found and fixed, is a pack you can sign with confidence.
Where to start
If you are not yet sure your product needs AUST L listing at all, start with the Food or Medicine Checker. It reads your product against the law Regulave holds and tells you, in plain words, which side of the line it sits.
This article is general information, not legal advice. The TGA's current application and guidance govern your submission.