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Medicines

Medicines are therapeutic goods that contain active ingredients intended to prevent, diagnose, cure, treat or alleviate symptoms of disease and medical conditions. 

About medicines


Medicines are substances used to treat, prevent or relieve symptoms of illness and injury, or to change how the body works. 

All medicines sold in Australia must meet safety and quality standards. 

We assess higher-risk medicines—like prescription, over-the-counter and registered complementary medicines—to make sure they are safe and work as they claim. 

Lower-risk medicines, such as listed medicines, are not assessed by us before theyo on the market. These medicines can only use low-risk ingredients and have low-level indications (health claims) from our pre-approved lists. 

Different types of medicines have specific rules and guidance, including: 

  • assessed listed medicines 

  • listed medicines 

  • over-the-counter medicines 

  • prescription medicines 

  • registered complementary medicines 

  • therapeutic sunscreens. 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.

An overview of medicines

Start here to get an overview of how your product is regulated and helpful information to support your journey.

More overview information

Regulation of medicines

Know your obligations at each point along your product’s regulatory journey.

Types of medicines

Explore different product types which have additional rules and requirements. Understand how to meet your obligations.

  • Assessed listed medicines

    An assessed listed medicine is a non-prescription product listed on the Australian Register of Therapeutic Goods (ARTG).

  • Listed medicines

    Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed on the Australian Register of Therapeutic Goods. Listed medicines can only contain low risk ingredients and use low level indications.

  • Over-the-counter medicines

    Over-the-counter medicines (OTC) medicines are non-prescription medicines that contain higher-risk ingredients and make higher-risk indications than registered complementary medicines or listed medicines.

  • Prescription medicines

    Prescription medicines are registered medicines that are accessed with a prescription from an authorised healthcare professional.

  • Registered complementary medicines

    Some complementary medicines are registered, meaning we have assessed them for quality, safety and efficacy. These products typically contain higher-risk ingredients or make higher-level therapeutic claims.

  • Therapeutic sunscreens

    We regulate sunscreens as therapeutic goods when they make therapeutic claims for sun protection.

Consumer and health professional topics

  • Cosmetics

    Topic
    Find out how cosmetic products are regulated.

  • Weight loss products

    Topic
    If you want to know more, we have developed comprehensive information on weight-loss products and what to be aware of.

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