The ARTG: what it is and how to check a product

In short

• The ARTG, the Australian Register of Therapeutic Goods, is the TGA's public database of the therapeutic goods that can be legally supplied in Australia.
• A medicine on it carries an AUST R, AUST L or AUST L(A) number on its label, which you can look up in the TGA's ARTG search, by number, name or sponsor.
• An entry means a product can be legally supplied (unless it is listed for export only), not always that the TGA evaluated it: listed (AUST L) medicines aren't individually evaluated before sale.
• Cancelled and suspended products no longer appear in the search.

What is the ARTG?

The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. It holds each product's name and formulation details, and the details of its sponsor and manufacturer.

The register exists under section 9A of the Therapeutic Goods Act 1989. Its purpose, in the Act's words, is "compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans". The TGA keeps it and enters goods on it.

With few exceptions, a therapeutic good that isn't on the ARTG can't be manufactured, imported, exported, supplied or advertised in Australia. Schedules 5 and 5A of the Therapeutic Goods Regulations 1990 exempt some goods from the Act's registration, listing and biologicals rules, some only under conditions. Some medical devices are exempt from inclusion too.

Goods that aren't on the ARTG can also reach individual patients or groups under specific conditions. The TGA's access pathways for this include the Special Access Scheme, the Authorised Prescriber Scheme, clinical trial schemes and the Personal Importation Scheme. The TGA says these schemes "cannot be used to facilitate the commercial supply of therapeutic goods": they are not a route to market.

What is on the ARTG?

The Act divides the register into five parts: registered goods, provisionally registered goods, listed goods, biologicals and medical devices. Non-prescription medicines go on it as listed, assessed listed or registered medicines.

Kind of entry	Number	What it covers
Registered medicine	AUST R	Higher-risk medicines: all prescription medicines, most over-the-counter ones such as pain relief and antihistamines, and higher dose iron supplements
Listed medicine	AUST L	The lowest-risk non-prescription medicines, such as vitamins, herbal medicines, Traditional Chinese Medicines and some sunscreens
Assessed listed medicine	AUST L(A)	Medicines like listed ones that can also make intermediate indications, whose efficacy the TGA assesses before sale
Medical device	ARTG number	Class I devices such as bandages and splints; Class III devices such as pacemakers

A medicine on the ARTG must carry its AUST number on the label. The TGA says this number is also known as the ARTG ID, or the registration or listing number.

Whether a product is a medicine at all, rather than a food or a cosmetic, is a separate question: see medicine, food or cosmetic?

How to search the ARTG

The TGA's ARTG search covers the medicines, medical devices and biologicals that can be supplied in Australia.

1. Find the number. On a medicine, look for the AUST R, AUST L or AUST L(A) number on the label.
2. Search for it. The search works by name, ID or sponsor, so enter the number, the product name or the sponsor.
3. Narrow the results. Filter them by sponsor or by published date.
4. Check the entry. Results include the product name and formulation details, the sponsor and manufacturer details, and Consumer Medicine Information (CMI) and Product Information (PI). Not all CMI and PI documents are available.
5. Read the public summary. It gives details such as the sponsor and the product's intended purpose or indications.

For a more detailed search, the TGA has an ARTG visualisation tool, built for larger screens and the Chrome browser.

A number from a pack that brings up nothing may belong to a product that has been cancelled or suspended. The TGA's 2021 search manual says the search shows only current entries. It suggests checking the number, and contacting the place of purchase if you have concerns.

What an ARTG entry tells you, and what it doesn't

An entry tells you the product can be legally supplied in Australia (unless it is listed for export only), who its sponsor is and what its formulation details are. For a medicine, the AUST number also tells you whether it is registered, listed or assessed listed.

That matters, because the TGA checks each tier differently. Medicines with AUST R and AUST L(A) numbers are assessed for efficacy; those with AUST L are not. Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied, and most complementary medicines are listed.

The TGA's own 2024–25 performance report makes the point. Some lower-risk goods are entered "on the basis of certifications made by the sponsor of the goods, rather than comprehensive pre-market evaluation". So being on the ARTG is not the same as being evaluated by the TGA.

Nor is the register advice: the TGA says it "is not intended to provide guidance, advice or recommendations" on the goods. And a public summary is not an ARTG certificate, which only the sponsor can view or print.

How a product gets on the ARTG

The sponsor, the individual or company intending to supply a product, is responsible for meeting the regulatory requirements. The TGA enters higher-risk goods once it has assessed them as meeting the requirements for quality, safety and, where appropriate, efficacy or performance. Lower-risk medicines, biologicals and medical devices go on once their applications have been validated (for a listed medicine, once the fee is paid too).

For a listed medicine, our TGA listing guide sets out what must be in place before lodging, the steps and the fees. In 2024–25 the TGA added 2,143 new listed medicines.

ARTG cancellations and suspensions

Under the Act, a registration or listing can be suspended (section 29D) or cancelled (section 30). Suspended and cancelled products no longer appear in the ARTG; the TGA lists them in separate databases, and its cancellations and suspensions database gives the grounds for each cancellation.

Complementary medicines can be cancelled after a TGA review. If a compliance review finds a listed medicine doesn't comply, the TGA acts according to the risk. It can require the sponsor to change the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it. Carrying out a recall is the sponsor's job.

The TGA also publishes sponsor-requested cancellations, and products cancelled for failure to pay annual charges.

Where we come in

We take listed medicines through to an ARTG listing for brands, then keep the listing current as the product changes. The listing comes once the formula, the evidence, stability data and the label are ready, and a licensed or GMP-cleared manufacturer is lined up. Our TGA listing guide covers each one, or book a call.