Overview of application process for non-prescription medicines

Non-prescription medicines must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be sold in Australia.

Non-prescription medicines cannot contain ingredients found in Schedules 4, 8 and 9 of the Poisons Standard. If medicines contain these ingredients, they must be prescription medicines.

Registered complementary and over-the-counter medicines

Registered complementary and over-the-counter medicines may include higher risk ingredients or may make health claims about more serious conditions than listed medicines, but not as high level as prescription medicines.

Because these medicines have more risk, we fully evaluate and confirm the safety, quality and efficacy of these medicines before they go on sale. The sponsor must provide high quality evidence to support the medicine, such as data from human clinical trials.

We monitor these medicines after they go on sale, and if we discover an issue, we can suspend or cancel the medicine's registration.

Registered complementary medicines may apply to use the 'TGA assessed' claim.

Assessed listed complementary medicines

Assessed listed complementary medicines make slightly higher risk indications (intended uses) than other listed medicines. For example, listed medicines are not able to reference conditions such as tinnitus or rheumatoid arthritis, but assessed listed medicines may be able to.

Because they make indications with more risk, assessed listed medicines undergo an efficacy assessment before going on sale. The sponsor must provide high quality evidence to support the medicine such as data from human clinical trials. Assessed listed medicines may display the 'TGA assessed' claim (as a symbol and/or a statement).

Find out more by reading our page on what 'TGA assessed' means

Listed complementary medicines

Listed complementary medicines are low risk, so are not assessed for efficacy before going on sale.

When a sponsor lists a medicine on the ARTG, they must declare that the medicine:

• contains only pre-approved low risk ingredients
• makes only pre-approved low risk health claims
• is supported by evidence that the sponsor of the medicine holds
• is manufactured at a licensed Australian site, or at an approved overseas facility
• complies with all other regulation, such as the Therapeutic Goods Advertising Code.

Listed medicines may be reviewed after they are on sale for compliance, which includes review of evidence. Non-compliant medicines may have their listing suspended or cancelled.