What an AUST L submission really contains

An AUST L application is short on the screen and long underneath. The form asks you to certify a list of things about your medicine, and each certification is a promise that you hold something: the evidence for a claim, a label that meets the rules, an ingredient the law allows. This guide reads that list from the Therapeutic Goods Act 1989 itself, and shows which document in a submission pack answers each promise, and why one extra step, an independent reviewer, matters more than it looks.

If you want the ten documents in brief first, read What actually goes into an AUST L submission. This is its companion: the same pack, read from the law's side.

Listing works on your word

Section 26A of the Act, Listing of certain medicines, sets the conditions for listing a medicine, and then it says something that shapes everything that follows. Once an application meets them, the Secretary must list the medicine "without inquiring into the correctness of the certificate or the notice" (section 26A(1A)).

In plain words: the listing is built on what you certify, and your certificate is not checked before the medicine is listed. So the work behind each certification has to exist before you certify it, because nobody checks it first.

What you certify

Section 26A(2) lists what "the applicant must certify". The list is long; here are the certifications this guide follows, in the Act's own words:

• "the medicine is eligible for listing";
• "the medicine is safe for the purposes for which it is to be used";
• "the presentation of the medicine is not unacceptable";
• "the medicine does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a)";
• "the medicine conforms to every standard (if any) applicable to the medicine";
• each indication proposed to be accepted "is covered by a determination under paragraph 26BF(1)(a)";
• "the applicant holds information or evidence to support each indication proposed to be accepted in relation to the inclusion of the medicine in the Register";
• and, for anything you claim that is not an indication, "the applicant holds information or evidence to support any claim (other than a claim that is an indication) proposed to be accepted in relation to the inclusion of the medicine in the Register";
• "the information included in or with the application is correct".

Two determinations do a lot of work in that list. The ingredients come from the Therapeutic Goods (Permissible Ingredients) Determination, "made under subsection 26BB(1)". The indications, the claims a listed medicine may make, come from the Therapeutic Goods (Permissible Indications) Determination, "made under section 26BF".

Which document answers which promise

A submission pack is only useful if each document answers a question the application will ask you. Here is how Regulave's pack lines up against the certifications above.

Every indication covered by the determination. The Indications & Claims Schedule maps every claim you intend to make to the Permissible Indications Determination, and shows the source's currency date. A claim that the determination does not cover is not a wording problem to fix later; it is a certification you cannot make.

Evidence held for every indication, and for any other claim. Four documents carry this one, because it is the heaviest:

• the Evidence Matrix records, for each claim, the type of evidence it needs and where the pack holds it;
• the Literature Search Log lists the papers found for each claim, with the search that found each one;
• the Literature Search Strategy records every query as it was run, what it returned, what was kept and what was refused, so the search can be repeated;
• the Scientific Evidence Record keeps each included paper with its citation, its study design in the paper's own words, its population and its intervention.

Every applicable standard met. For the label, that includes TGO 92, the standard for labels of non-prescription medicines. The Label Compliance (TGO 92) document draws the mandatory and warning requirements from the labelling order, your matched claims and your ingredients.

Only permissible ingredients. The Sponsor & Product Summary gathers your ingredients once, so every other document works from the same list, and the ingredient question is asked of one list, not several.

The information is correct. The Certification & Sign-off Record is the accountability record: every certification statement, who affirmed it, in what position, and when. The Pack Status page shows what is finished and what still needs you, and the TBS Lodgement Companion is a guide to what the TGA's online application will ask, while the live TGA screens govern.

The step that makes the difference: an independent reviewer

Because listing rests on your certifications, the most valuable thing a pack can do is find its own weak points before you certify it. That is what the independent-reviewer step is for.

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.

Set against section 26A(1A), the reason is plain. No one inquires into your certificate before listing. So the inquiry has to happen on your side, and it is better done by something built to disagree with the pack than by the person who hopes it is finished.

Three questions to ask of any pack

Whether you use Regulave's pack or build your own, three questions tell you whether the work will hold up when you certify on it.

1. Can you trace every statement? A claim should cite the determination it comes from, a label requirement the order that sets it, and a paper its own record. If a sentence has no source, you are certifying on faith.
2. Does it say what it does not know? Thin or missing evidence should be stated in plain words, not smoothed over. A gap you can see is a gap you can fix before you certify; a gap hidden in confident prose is one you find later.
3. Has anything tried to break it? A pack reviewed only by the people who assembled it has been checked for what they expected. One that something independent has tried to break, with each challenge re-tested against the evidence, has been checked for what they missed.

What a pack does not do

A pack is preparation, not lodgement. It does not submit your application, it does not speak to the TGA for you, and it does not replace your own judgement on what you certify: the certifications are yours. What it gives you is each certification's working, in one place, with every statement traced to its source and every gap stated in plain words rather than filled.

Before you start

AUST L is the right path only if your product is a therapeutic good. If you are not sure, read Do I need AUST L listing for my supplement? The five-minute answer, and check your exact formulation first. The Food or Medicine Checker reads your product against the law and tells you, in plain words, which side of the line it sits, with every rule it relied on one click away.

Check your product with the Food or Medicine Checker →

---

This article is general information built from the legal instruments Regulave holds, current when it was written. It is not legal advice. The TGA's current application and guidance govern your submission.