Listed medicines information for new sponsors

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.

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.
 

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.

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.

You can email us for support at nonprescriptionmedicines@health.gov.au.