TGA listed means a product's sponsor has certified its safety, quality and ingredients to the Therapeutic Goods Administration and the product has been entered on the ARTG, Australia's public register of legal therapeutic goods. It does not mean the TGA has tested the product for effectiveness; that is a different category called Registered (AUST R). Hoola is TGA listed under AUST L 508472.
Key facts:
- An AUST L number means the sponsor certified the product and it is entered on the ARTG.
- The TGA does not evaluate listed medicines for efficacy before sale.
- About 12,000 medicines are listed on the ARTG at any one time.
- Every ingredient in a listed medicine must come from the TGA's permitted list, pre-assessed as safe and low risk.
- The TGA polices listed medicines after sale through compliance reviews and publishes the results.
- Hoola is TGA listed under AUST L 508472.
What "TGA listed" means on a supplement label
TGA listed means the product is entered on the Australian Register of Therapeutic Goods (ARTG) as a listed medicine, with an AUST L number that must appear on the label and packaging. Every medicine supplied in Australia must be included in the ARTG before sale, either as a registered medicine or as a listed medicine. The Therapeutic Goods Administration (TGA) runs the register.
A listed medicine is a lower risk medicine that reaches the market on the sponsor's certification. The sponsor is the company that owns the product and supplies it in Australia. To list a medicine, the sponsor certifies to the TGA that the product meets the safety, quality and ingredient requirements for listed medicines. The TGA then enters the product on the register and issues the AUST L number.
Listed medicines cover the lower risk end of the market: vitamins, herbal medicines, traditional Chinese medicines and some sunscreens. They sell off the shelf, with no prescription. The TGA describes its system as risk-based, with "more rigorous controls on higher risk registered medicines than lower risk listed medicines". The TGA's listed medicines overview sets out the category in full.
What TGA listed does not mean
The TGA does not individually evaluate a listed medicine for quality, safety or efficacy before it is supplied. The product enters the register on the sponsor's certification alone. The label goes to market unassessed as well; only registered medicines have their labels approved before sale.
The certification carries real legal weight. The sponsor must hold evidence behind every indication on the product and must produce it when the TGA asks. False certification is an offence.
Regulatory consultancy Engel Hellyer drew the line sharply in August 2026: the AUST L number "means the sponsor has declared compliance, not that the regulator has confirmed it".
Most buyers never learn any of this. Choice's Consumer Pulse survey of 1,052 people found that 80% had never noticed the AUST numbers on labels. Of the group who had, 43% wrongly believed listed products had been evaluated by the TGA for efficacy. Choice's listed-versus-registered article, last updated 2018, reports both figures. We state the distinction plainly because a buyer who knows what the number certifies can read every supplement label in the country, ours included, with clear eyes.
AUST L, AUST L(A) and AUST R: the three numbers on Australian labels
Australian medicine labels carry one of three numbers: AUST L for listed medicines, AUST L(A) for assessed listed medicines and AUST R for registered medicines. Each number marks a different level of pre-market scrutiny.
AUST L: listed medicines
An AUST L number marks a listed medicine: the sponsor certifies safety, quality and ingredients to the TGA, and the product is entered on the ARTG without pre-market efficacy assessment. Ingredients and indications both come from permitted lists. Complementary medicines, including vitamins, are mostly listed.
AUST L(A): assessed listed medicines
An AUST L(A) number marks an assessed listed medicine: its ingredients still come from the permitted list, but the TGA assesses its health claims for efficacy before sale. Only this tier, plus registered complementary medicines on application, may state "TGA assessed" on the label as a symbol or a statement.
AUST R: registered medicines
An AUST R number marks a registered medicine: the product is individually evaluated for safety, quality and efficacy before sale, usually against clinical trial evidence, and its label is approved before it reaches the market. All prescription medicines are registered. Few complementary medicines are.
The TGA's how we regulate medicines page publishes the official comparison. Expanded, the three tiers look like this:
| Control | AUST L | AUST L(A) | AUST R |
|---|---|---|---|
| Pre-market efficacy assessment | No | Yes | Yes |
| Ingredients | Permitted list | Permitted list | Evaluated pre-market |
| Indications | Permitted list | Assessed pre-market | Assessed pre-market |
| Post-market compliance reviews | Yes | Yes | No |
| Post-market surveillance | Yes | Yes | Yes |
| Off the shelf, no prescription | Yes | Yes | Prescription for some |
| "TGA assessed" claim | No | Yes | Complementary only, on application |
| GMP manufacturing required | Yes | Yes | Yes |
The tier decides what a product may say. The TGA's own examples: a listed medicine may claim it "relieves throat irritation" but never that it "reduces high blood pressure" or "cures rheumatoid arthritis". An assessed listed medicine might reference a condition such as tinnitus.
Manufacturing is the one control that never varies. Every medicine on the ARTG, whatever its number, must be made in a licensed facility under GMP.
The rules every listed medicine must follow
A listed medicine operates inside five standing controls: permitted ingredients, permitted indications, banned representations, mandatory warning statements and GMP manufacturing. Self-certification covers the paperwork; these controls set what the paperwork must certify.
Ingredients must come from the permitted list
Every ingredient in a listed medicine must come from the Therapeutic Goods (Permissible Ingredients) Determination, a list of ingredients the TGA has pre-assessed as safe and low risk. Some entries on the list carry limits; the TGA names caffeine amount restrictions as its example. An ingredient outside the Determination cannot go into a listed medicine at all.
Indications must come from the permitted list and be backed by held evidence
Every indication on a listed medicine is pre-worded and selected from a permitted list. The sponsor must hold scientific evidence or evidence of traditional use behind each one, and must produce that evidence when the TGA asks.
Serious conditions are banned from labels and advertising
Restricted and prohibited representations bar listed medicines from mentioning serious conditions. The TGA names rheumatoid arthritis and depression as examples of conditions that cannot appear on a listed medicine's label or in its advertising.
Mandatory warning statements
Mandatory warning statements must appear on a listed medicine wherever the rules require them. A missing mandatory warning statement is one of the triggers the TGA uses to select a medicine for a targeted compliance review.
Manufacturing under GMP
Every listed medicine must be manufactured in a licensed facility under GMP. The requirement applies before a single unit is sold and holds for as long as the product stays on the register.
How the TGA polices listed medicines after sale
The TGA polices listed medicines after sale through compliance reviews: audits of a product's evidence, quality and advertising once it is already on the market. The TGA's compliance reviews guidance sets out the whole process.
The scale of the task
Approximately 12,000 medicines are listed on the ARTG at any one time, and over 1,000 new medicines are listed each year. The TGA selects only some for review each year, so it aims the reviews where the risk sits.
How medicines are picked for review
Targeted reviews prioritise medicines that show specific risk signals:
- potential health risk
- claims that significantly mislead the public
- missing mandatory warning statements
- indications outside the ARTG entry or the Permissible Indications Determination
- breaches of the Permissible Ingredients Determination or the Poisons Standard
- quality issues
- sponsors with repeat non-compliance
The intelligence behind the targeting comes from lab testing, adverse event reports, public and media reports, screening of recently listed medicines and prior reviews. Random reviews run alongside the targeted ones, selected by computer algorithm.
The five-stage process and where its teeth are
A compliance review runs through five stages: initiation, review, response, decision and publication.
- Initiation. The TGA sends the sponsor a request-for-information notice. It can demand labels and supply status, advertising pages, finished product specifications, a certificate of analysis for the last released batch, the manufacturing formula with all ingredient quantities and the evidence held for every indication and claim. A sponsor that fails to respond risks cancellation under section 30.
- Review. The TGA examines what comes back. Engel Hellyer describes the work as a desktop audit of held evidence, lab testing of market samples and advertising scrutiny.
- Response. The sponsor may rebut the findings or rectify the problems.
- Decision. The TGA decides the outcome. A sponsor can seek reconsideration within 90 days under section 60.
- Publication. Outcomes go into the public database of TGA listed medicine compliance review results. Cancellations are published as well.
Cancellation removes the entry from the ARTG, and a medicine off the register cannot be legally supplied in Australia. Non-compliance can also lead to suspension of the listing or a recall. The TGA's Compliance Principles for 2026-2027 set proactive, risk-based enforcement and name listed medicine advertising as a priority area.
A worked example: reading Hoola's ARTG entry
ARTG entry 508472 is Hoola's own listing, and every field in it is public. Anyone can open ARTG entry 508472 and read it, no account needed. Field by field:
| Field | Entry |
|---|---|
| ARTG ID | 508472 |
| ARTG name | HOOLA |
| Product name | HOOLA |
| Registration type | Medicine |
| Sponsor | Hoola Australia Pty Ltd |
| ARTG date | 8 August 2025 |
| Licence status | A |
What the fields tell a buyer:
- ARTG ID is the number to match against the pack. Our label reads AUST L 508472; the entry reads 508472. A mismatch between label and register is the first red flag on any product.
- Sponsor names the company legally responsible for the product in Australia. Ours reads Hoola Australia Pty Ltd, so the certification behind the listing sits with us under our own name.
- ARTG date shows when the product entered the register: 8 August 2025 for this entry.
- Registration type confirms the entry is a medicine, so the ARTG's medicine controls apply to it.
The entry also carries a public ingredient list. Ours names Withania somnifera, Bacopa monnieri, Alpinia galanga, Panax ginseng, Cordyceps sinensis, Ganoderma lucidum, caffeine and the vitamin and mineral actives. A buyer can hold the Hoola pack in one hand and the register entry in the other and compare the two directly.
How to check any supplement yourself
You can check any supplement sold in Australia in three steps on the public ARTG search. The search is free and covers every TGA listed product and every registered medicine.
- Find the AUST number on the label. Every medicine supplied in Australia must be on the ARTG, so the label carries AUST L, AUST L(A) or AUST R.
- Enter the number in the public ARTG search.
- Open the entry. Compare the product name, the sponsor and the ingredient list against the pack in your hand.
One trap sits outside the register. Products sold on international websites are not regulated by the TGA, and the TGA advises against ordering medicines from overseas sites without checking exactly what is in them and the import rules. None of the controls above apply to those purchases.
FAQ
What is the difference between a listed medicine and a registered medicine?
A listed medicine (AUST L) is entered on the ARTG on the sponsor's certification that it meets safety, quality and ingredient requirements; the TGA does not evaluate it for efficacy before sale. A registered medicine (AUST R) is individually assessed by the TGA for safety, quality and efficacy before sale, usually against clinical trial evidence.
Does the TGA test listed medicines before they are sold?
No. The TGA does not individually evaluate listed medicines for quality, safety or efficacy before supply. The sponsor certifies compliance and false certification is an offence. After sale the TGA checks the market through compliance reviews, which can include lab testing of samples.
What does the AUST L number on a label mean?
An AUST L number means the product is a listed medicine on the Australian Register of Therapeutic Goods. The sponsor has certified its safety, quality and ingredients to the TGA, and the number must be displayed on the label and packaging.
What does AUST L(A) mean, and what is the "TGA assessed" claim?
AUST L(A) marks an assessed listed medicine. Its ingredients still come from the permitted list, but the TGA assesses its health claims for efficacy before sale. Only assessed listed medicines, and registered complementary medicines on application, may carry the "TGA assessed" claim on the label as a symbol or a statement.
Is a listed medicine regulated?
Yes. A listed medicine must be entered on the ARTG before sale, use only ingredients from the Permissible Ingredients Determination, carry only permitted indications backed by held evidence, and be manufactured in a licensed facility under GMP. The TGA also runs post-market compliance reviews on listed medicines and monitors adverse events.
Which products have to be on the ARTG?
All medicines supplied in Australia must be included in the ARTG, either as registered medicines or as listed medicines. Listed medicines include vitamins, herbal medicines, traditional Chinese medicines and some sunscreens. All prescription medicines are registered.
Can a listed medicine be cancelled or recalled?
Yes. Non-compliance found in a compliance review can lead to suspension or cancellation of the ARTG entry, and a recall can follow. A sponsor that fails to respond to a review notice risks cancellation under section 30. Cancellation ends legal supply in Australia, and outcomes are published in the TGA's public database of compliance review results.
Does a TGA listing cover supplements bought from overseas websites?
No. Products sold on international websites are not regulated by the TGA. The TGA advises against ordering medicines from overseas sites without checking exactly what is in them and the import rules.
Look up AUST L 508472
You now know what the AUST L number certifies, who stands behind it and how the TGA polices it after sale. Put that knowledge to work on us first. Search AUST L 508472 on the public ARTG search, open the entry and compare it against the Hoola label. Then read our regulatory compliance page for the detail we publish on our own obligations.
