Non-prescription medicines

Non-prescription medicines can be bought off the shelf from supermarkets, health food shops or over the counter from pharmacies, depending on their level of risk.

Non-prescription medicines are entered on the Australian Register of Therapeutic Goods (ARTG) as either listed, assessed listed or registered medicines. This is based on their level of risk to the consumer, determined by the ingredients they contain and their intended use (therapeutic indications).

All non-prescription medicines must be manufactured in a licensed or approved facility according to good manufacturing practice (GMP) principles.

Some non-prescription medicines are commonly referred to as complementary medicines.

Listed medicines

• Lowest risk non-prescription medicines.
• Have ‘AUST L’ on the label.
• Not individually evaluated by the TGA for quality, safety and efficacy before they are supplied in the marketplace.
• Ingredients are selected from a TGA pre-approved ingredients list.
• More information about listed medicines. 

Assessed listed medicines

• Lower risk non-prescription medicines.
• Have ‘AUST L(A)’ on the label.
• Therapeutic indications have been assessed by the TGA for efficacy before they are supplied in the marketplace.
• Ingredients are selected from a TGA pre-approved ingredients list.
• Can use the ‘TGA assessed’ claim on their label.
• More information about assessed listed medicines.

Registered non-prescription medicines

• Higher risk non-prescription medicines.
• Have ‘AUST R’ on the label.
• TGA performs a full pre-market evaluation of their safety, quality and efficacy before they are supplied in the market.
• Two main types of registered non-prescription medicines:
  • Over the counter (OTC) medicines, such as pain relief, antihistamines, nicotine replacement therapy.
  • Registered complementary medicines, such as higher dose iron supplements.
• Registered complementary medicines can use the ‘TGA assessed’ claim on their label.