Permissible ingredients: getting a new ingredient approved for listed medicines

What needs an application

In the TGA's words, all listed medicines, "AUST L listed medicines, and AUST L(A) assessed listed medicines", may only contain ingredients included in the Therapeutic Goods (Permissible Ingredients) Determination. Its requirements apply too: each ingredient can only be used for the purposes and within the limits the Determination sets.

So an application is needed for:

• A new substance, one not in the Determination at all.
• A new role for a permitted ingredient, such as an ingredient permitted as an excipient that you want to use as an active.
• A change to its requirements, such as a higher permitted level of use or a new route of administration.

Generally, a substance can only be evaluated if it isn't a prohibited import and isn't, nor are its components, in a Schedule to the Poisons Standard.

The Determination changes often: the current one is the third of 2026, and the TGA says updates to listed medicine ingredients "occur quarterly at minimum". Checking every ingredient, its form and its dose against the current Determination is step 2 of an AUST L listing.

The four application levels

The level depends on whose evaluation the safety and quality case rests on. Where an applicant can provide an unredacted evaluation report from a comparable overseas body (a regulator on the TGA's list), or the ingredient's quality is set by a monograph in a default standard, the TGA asks for less supporting information and the timeframe is shorter.

Level	Safety	Quality
IN1	From a comparable overseas body's evaluation report	From a comparable overseas body's evaluation report, or a monograph in a default standard
IN2	From a comparable overseas body's evaluation report	Evaluated by the TGA
IN3	Evaluated by the TGA	From a comparable overseas body's evaluation report, or a monograph in a default standard
IN4	Evaluated by the TGA	Evaluated by the TGA

The applicant selects the level, and the TGA confirms it during the preliminary assessment. The ingredient should be equivalent to the one the overseas body evaluated: the TGA's guidance on using those reports says any differences "must be clearly justified".

The steps

1. A name first, if it needs one. If the substance has no approved name that can be selected from the TGA's approved names list, a proposal for a new name comes before the application.
2. A pre-submission meeting, if you want one. It is optional and has no fee, and the TGA may answer the questions in writing instead.
3. Lodge the whole dossier. The application form goes in through TGA Business Services with the dossier for the chosen level and the application fee. The TGA asks for all the data at lodgement: leaving relevant data out can stop the application being accepted, and it doesn't accept unsolicited data later.
4. Preliminary assessment. Within 40 working days the TGA identifies any critical deficiencies, confirms the level and says in writing whether the application goes to evaluation. If it does, an invoice for the evaluation fee follows, and the application lapses if it isn't paid within two months.
5. Evaluation. It starts once the evaluation fee is paid. The TGA can ask for more information, and the clock stops while the applicant answers.
6. Recommendation and decision. The TGA recommends whether the substance should be added, and a delegate of the Minister decides whether to vary the Determination. Once it is varied, the ingredient can be used in listed medicines. A refusal to recommend can be appealed under section 60 of the Act.

Anyone can apply: the TGA describes the applicant as someone "who may or may not be a medicine sponsor", so an ingredient supplier can apply as well as a brand.

What the dossier needs

Quality. Unless a monograph in a default standard covers the ingredient, its specifications are set out in a compositional guideline, and the TGA publishes compositional guidelines on its website. The TGA asks for batch analyses of at least two commercial-scale batches of an active ingredient, specifications that cover all known or likely impurities and incidental constituents, and real-time and accelerated stability data for two commercial-scale batches.

Safety. The dossier needs a systematic literature search, with its search strategy, and a history of use that establishes how much of the substance people are already exposed to. Safety data sheets alone aren't acceptable. Well-established use in food can support safety, with any reference in the Food Standards Code, but the TGA notes that food regulation generally has no pre-market evaluation or system for reporting adverse reactions.

Efficacy. Not part of an ingredient application. Evidence for the claims comes later: when a medicine using the ingredient is listed, its sponsor certifies that it holds evidence for every indication. More in our claims and indications guide.

Fees and timeframes for 2026–27

Level	Application fee	Evaluation fee	Preliminary assessment	Evaluation
IN1	$1,370	$18,456	40 working days	70 working days
IN2	$1,370	$18,456	40 working days	120 working days
IN3	$3,629	$30,067	40 working days	150 working days
IN4	$3,629	$30,067	40 working days	180 working days

• Working days only. The timeframes exclude weekends and public holidays, and the time the clock is stopped: while the applicant answers a formal request for information, or when the applicant and the TGA agree to stop it.
• The two phases run one after the other. Added together, the legislated maximums come to 110 working days for IN1 and 220 for IN4 (22 to 44 weeks), before any clock stops, the two months to pay the evaluation invoice, a name proposal or the time it takes to prepare the dossier.
• Refunds. The application fee isn't refunded if the application isn't accepted for evaluation, and the evaluation fee isn't refunded if the application is withdrawn during evaluation. If the TGA doesn't make its recommendation within the evaluation timeframe, it must refund 25% of the evaluation fee.

These are the TGA's fees only. Our TGA listing guide adds them up with the listing and the annual charge for a whole plan, and what a supplement costs to develop covers the rest of the budget.

Two years of exclusive use

A successful applicant for a new ingredient can ask for exclusive use of it. In the TGA's words, the Act "allows the Minister to permit the successful applicant to have exclusive use of that ingredient for a 2 year period (the protected ingredient)".

• It is optional, and you opt in when you apply. The TGA puts it on the applicant to opt in at the time of the application.
• It runs for two calendar years from the date the ingredient is included in the Determination. After that, any sponsor can use it.
• New ingredients only. It doesn't apply to an application for a new role or a change to an ingredient's requirements, or to an ingredient evaluated as part of an application for a registered complementary medicine.
• The owner can authorise others. The ingredient's owner and the sponsors it authorises are named in the Determination, by name and TGA client ID. The TGA won't step into disagreements between sponsors, manufacturers or suppliers.

So if an ingredient you want was added recently, check the Determination: its supplier may hold exclusive rights for a while yet.

If the ingredient isn't permitted yet

• A permitted alternative. Often the fastest route: another form of the ingredient, another ingredient for the same purpose, or a dose within the current limits.
• Apply, and plan the launch around it. The evaluation sets the earliest date a listed medicine using the ingredient can go on the market, so the formula, the evidence and the label are prepared alongside it. See how long it takes.
• Assessed listing is not a way round it. The Determination lists the ingredients for listed and assessed listed medicines alike.
• Registration is a far bigger application. For a registered medicine (AUST R), a new ingredient is typically evaluated as part of the application to enter the medicine on the ARTG.
• A food is a different question. Whether a product can be a food depends on how it is presented, and its ingredients must then be permitted in food under the Food Standards Code. See supplements as foods, and our novel foods guide for a food ingredient that is new.

Where we come in

We design the formula inside the permitted ingredients, with every ingredient, its form and its dose checked against the current Determination before anything is quoted. If the ingredient you want isn't allowed yet, we'll tell you what's realistic, then manage the application (new ingredient applications) or find the permitted alternative. Our formulation comes with early access to new ingredients through our global ingredient network, and our formulas are built on clinically studied ones: affron® saffron for EverLeanBody, and AnaGain™ under licence for Vitable. More on formulation, or book a call.