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How we regulate medicines

20 June 2019

Overview

All medicines supplied in Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Medicines will be either registered or listed in the ARTG. You can tell whether a medicine is registered or listed by the AUST L, AUST L(A) or AUST R number on the label (this is the ARTG number for the medicine).

Registered medicines are always evaluated for efficacy (that the medicine can do what it says it will) before they go on sale. But not all listed medicines are evaluated for efficacy.

There are two types of listed medicines:

  • AUST L 'listed' medicines, which have not been assessed for efficacy
  • AUST L(A) 'assessed listed' medicines, which have had their health claims assessed for efficacy.

Regardless of whether a medicine is registered or listed in the ARTG, it must be manufactured in a licensed or approved facility in accordance with the principles of good manufacturing practice (GMP).

The table below shows the differences between listed, assessed listed and registered medicines.

Listed

Assessed listed

Registered

ARTG/AUST number

AUST L

AUST L(A)

AUST R

Pre-market efficacy assessment

No

Yes

Yes

Ingredients

From a list of pre-approved ingredients only

From a list of pre-approved ingredients only

Ingredients are assessed pre-market

Indications (conditions the medicine says it will treat)

From a list of pre-approved conditions only

Conditions are assessed pre-market

Conditions are assessed pre-market

Subject to post-market compliance reviews

Yes

Yes

No

Subject to post market surveillance (e.g. adverse event monitoring)

Yes

Yes

Yes

Available off-the-shelf

Yes

Yes

Some

Need for a prescription from a health professional

No

No

Some

Able to use 'TGA assessed' claim

No

Yes

Yes, for registered complementary medicines

How types of medicine are included in the ARTG

Registered (AUST R)

Listed (AUST L & AUST L(A))

Complementary

Few

Most

Over-the-counter

Most

Some

Prescription

All

None

Why are there different processes for registered and listed medicines?

No medicine is 100% risk-free, but the risk is greater for some medicines. We take a risk-based approach to regulation where we have more rigorous controls on higher risk registered medicines than lower risk listed medicines.

Registered medicines

Registered medicines are higher risk. Because of this we fully assess all registered medicines for safety, quality and efficacy before they go on sale. We also approve the medicine's label before it reaches the market. Once the medicine is available, we continue to monitor it to make sure it remains safe. If any issues with the medicine emerge, we may suspend or cancel the medicine's registration.

How a registered medicine is sold depends on the type of medicine it is. Most registered complementary and registered over-the-counter medicines are available off the shelf. However some registered over-the-counter medicines are only available from a pharmacist after a consultation, and prescription medicines are only available with a valid prescription from a health professional.

Listed medicines

Listed medicines are lower risk and can be purchased off the shelf from pharmacies, health shops, and supermarkets.

Unlike registered medicines, we do not assess each listed medicine for efficacy before it goes onto the market. We also do not approve the medicine label before it reaches the market. This is because we take a risk-based approach to regulation, which means higher risk medicines have more rigorous controls than lower risk medicines. However, we do require sponsors to certify that the medicine complies with all relevant regulation, and that they hold evidence that their medicine does what it says it will.

Because these medicines do not go through any pre-market assessment, we only allow listed medicines to contain pre-approved low risk ingredients and make low level health claims. For example, a listed medicine may make the low risk claim that it 'relieves throat irritation', but not high risk claims such as 'reduces high blood pressure' or 'cures rheumatoid arthritis'.

We may select a listed medicine for a post-market review where we require the sponsor to provide evidence of compliance with regulation. This includes assessment of evidence of efficacy and labelling. If we find the medicine does not comply with all applicable regulatory requirements, the medicine's listing may be suspended or cancelled.

Assessed listed medicines

Assessed listed medicines make slightly riskier health claims than other listed medicines. For example, a listed medicine would not be able to reference a condition like tinnitus or rheumatoid arthritis, but an assessed listed medicine might be able to. These medicines are assessed for efficacy before going on sale. Because their efficacy has been assessed pre-market, assessed listed medicines may use a 'TGA assessed' claim on the medicine label (this can be as a symbol and/or a statement).

Registered complementary medicines may also apply to use the 'TGA assessed' claim. The 'TGA assessed' claim is not displayed on other registered medicines.

See the 'What does 'TGA assessed' mean on my medicine label?' webpage to learn more about the 'TGA assessed' claim.