Registered and listed medicines

The AUST L or AUST R number on your medicine package shows that the TGA has evaluated the product and it is on the Australian Register of Therapeutic Goods (ARTG).

Watch this video to find out:

  • the difference between registered (AUST R) and listed (AUST L) goods
  • how the different products are evaluated
  • what this means for you as a consumer.

Transcript

Registered and listed medicines

What do the labels on my medicines mean?

Medicine labels tell you important information about the product you're buying - including how to use it, how to store it and the expiry date.

They also show if your medicine is registered (AUST R) or listed (AUST L).

Medicines supplied in Australia are either registered or listed on the Australian Register of Therapeutic Goods (ARTG), depending on the claims that are made about the medicine, and the benefits and risks associated with using it.

  • Registered - AUST R = higher risk
  • Listed - AUST L = lower risk

Tell me more about registered medicines

Registered or AUST R medicines are those considered higher risk.

You use them to treat more serious illnesses, from a migraine all the way through to diseases like cancer.

AUST R medicines include:

  • all prescription medicines (such as antibiotics)
  • most over-the-counter medicines (like painkillers, antihistamines, anti-fungal treatments)
  • some complementary medicines (for example, high dose calcium supplements).

These medicines must have an AUST R number on the label.

How are registered medicines assessed?

The TGA assesses the safety and quality of AUST R medicines.

The TGA also looks at the evidence that AUST R medicines work effectively.

Tell me more about listed medicines

Generally, listed medicines can be purchased off the shelf at supermarkets, health food shops, pharmacies and other retailers.

AUST L medicines include:

  • vitamin and mineral supplements
  • herbal medicines

These medicines must have an AUST L number on the label.

What are listed medicines assessed for?

The TGA assesses the safety and quality of the ingredients in AUST L medicines.

AUST L medicines can only use pre-approved, lower risk ingredients.

They must not make claims or imply that they will be useful in the treatment or prevention of serious illnesses that would require the involvement of a health professional.

The supplier must also make a statutory declaration that the information they are providing to the TGA is true.

Everyone is unique

Just because the TGA authorised a particular medicine, does not mean that this is the best option for you.

You must always discuss the benefits and risks with your doctor, pharmacist or another health professional when using any medicine.

Make sure that you:

  • are aware there are risks associated with taking all medicines
  • tell your health professional about all the therapeutic goods you are taking and any other therapies you are undergoing
  • always read the label carefully, look closely at the claims and follow the instructions for use
  • report any unexpected side effects or problems to the TGA.

You can find more information about medicines on the NPS Medicinewise website: www.nps.org.au

Can you tell me a bit about product testing?

Testing by the TGA is usually for a particular reason.

For example, some medicines:

  • are harder to manufacture consistently
  • are suspected to be counterfeit
  • are tested for extra unnamed ingredients

You can find more information about what products are tested and what actions are taken on the TGA website.

Manufacturers are inspected too...

Medicines must be made in an environment that meets high standards of quality.

The TGA assesses and checks that all manufacturers of all medicines are meeting these good manufacturing practice standards.

You can find out more:

www.tga.gov.au

1800 020 653

Consumer Medicines Information (CMI) for most prescription medicines is available from your pharmacist and on the TGA website.

More information from the TGA

Explore the TGA website and find information related to this presentation with the links below.

Disclaimer

These educational materials are provided by the TGA (a part of the Department of Health) solely for the purpose of providing general education on the TGA regulatory scheme. The materials should not be taken to be a detailed description of the scheme, or advice on the application of the therapeutic goods legislation in particular cases. Nor should they be taken to be statements of policy.

People requiring information or advice on the application of the therapeutic goods legislation in particular cases should make their own enquiries.

Whilst due care has been taken in their preparation, the Department of Health cannot guarantee, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information contained in these materials.

These materials are based on the scheme as it is in February 2014.