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Complementary medicines overview

20 June 2019

What is a complementary medicine?

Complementary medicines are non-prescription medicines available from health food shops, supermarkets and pharmacies. Most of these medicines are available for purchase on the shelf for consumers to select, unlike prescription medicines (prescribed by a doctor) and some OTC medicines (selected by a pharmacist).

Complementary medicines should not replace medical treatments recommended by healthcare professionals.

Some examples of complementary medicines include:

  • traditional herbal medicines
  • some nutritional supplements
  • vitamins and minerals
  • homeopathic (diluted) preparations
  • aromatherapy preparations including essential oils
  • traditional Chinese medicines
  • Ayurvedic (traditional Indian) medicines.

How we regulate complementary medicines

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

There are three types of complementary medicines:

  • listed complementary medicines, which have an AUST L number on the label
  • assessed listed complementary medicines, which have an AUST L(A) number on the label
  • registered complementary medicines, which will have an AUST R number on the label.

Listed medicines and assessed listed medicines are usually chosen by the consumer, rather than prescribed or recommended by a doctor or pharmacist. Almost all complementary medicines are listed.

Registered medicines are higher risk, and while some are able to be chosen by the consumer, some are only available through a health professional.

Listed complementary medicines

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

When a sponsoring company 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.

Assessed listed complementary medicines

TGA assessed symbol

Assessed listed complementary medicines make slightly riskier health claims 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 health claims with more risk, assessed listed medicines undergo an efficacy assessment before going on sale. The sponsoring company 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

Registered complementary medicines

Registered complementary medicines may include higher risk ingredients or may make health claims about more serious conditions.

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 sponsoring company 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.