About listed medicines
A listed medicine is a lower risk non-prescription medicine. We don't evaluate listed medicines individually for safety, quality and efficacy (effectiveness) before they go onto the market. However, they can only use low-risk ingredients and make low-level indications (health claims) from our approved lists, as well as meeting all other applicable legislative requirements. Most listed medicines are complementary medicines. Some over-the-counter products like sunscreens are also regulated as listed medicines.
Assessed listed medicines can also only use low-risk ingredients from our approved list. However, they can make higher level intermediate indications because we assess the evidence supporting the indications before they go onto the market. If you think your product could be an assessed listed medicine, read Understanding the application requirements for an assessed listed medicine for more information.
Being a sponsor
Sponsor, in relation to therapeutic goods, means:
(a) a person who exports, or arranges the exportation of, the goods from Australia; or
(b) a person who imports, or arranges the importation of, the goods into Australia; or
(c) a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);
but does not include a person who:
(d) exports, imports or manufactures the goods; or
(e) arranges the exportation, importation or manufacture of the goods;
on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.
Sponsors must be an Australian resident or carry on business in Australia to get a therapeutic good listed in the Australian Register of Therapeutic Goods (ARTG).
Find out more about being a sponsor.
Listing your product in the Australian Register of Therapeutic Goods
All medicines supplied in Australia must be included in the ARTG. Know how to meet your responsibilities as a sponsor and the steps you need to undertake to list your medicine.
Understand the regulation and legislation
The Australian Regulatory Guidelines for Listed Medicines is a key resource that helps you understand and meet your obligations under the Therapeutic Goods Act 1989.
It gives clear guidance on everything from application requirements to post-market responsibilities.
How to list your medicine in the ARTG
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Get access to our business portal
If you're a new sponsor and don't yet have access to the TGA Business Services (TBS) portal, you'll need to register. Find out how to get started with the TGA.
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Apply to list your medicine in the ARTG
You can use the TBS portal to list your medicine in the ARTG without our pre-market assessment.
You must certify that the product meets all legislative requirements for safety, quality and efficacy. This includes certifications under section 26A(2)(a) to (k) and, if applicable, section 26A(2A) of the Therapeutic Goods Act 1989.
You can read Listed and assessed listed medicines: application and submission user guide to help you get started. You can also use our tool: What do I require to have a listed medicine in the ARTG?
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Our Electronic Listing Facility checks your listing
When you complete your application and submit it, our Electronic Listing Facility (ELF) will check your listing against our requirements. If there are no errors in your application, you will get a message that your application has ‘passed validation’. Although the ELF validates listings, this does not mean that the TGA has confirmed that your medicine meets all regulatory requirements - you are responsible for your ensuring your medicine meets all applicable regulatory requirements.
When the application passes ELF validation, the medicine is listed in the ARTG and given an AUST L number.
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Meet ongoing obligations
You must comply with any conditions set out in the Conditions of Listing Determination or in section 28 of the Therapeutic Goods Act 1989.
We can impose new conditions at any time the medicine remains listed in the ARTG.
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Be aware that you can be selected for a compliance review
While the medicine remains in the ARTG, we can do a post market review at any time to check if the medicine meets all applicable legislative requirements. A compliance review can include a request for information or data so that the TGA can assess the labelling, quality, safety or efficacy of the product.
Find out more about our listed medicine compliance reviews.
Get help
You can email us for support at nonprescriptionmedicines@health.gov.au.