Registered complementary medicines

Registered complementary medicines primarily contain complementary medicine ingredients with a clearly established identity and tradition of use e.g. vitamins, minerals and plant material.

Registered complementary medicines are sold without a doctor’s prescription. They are higher risk than listed medicines, but lower risk than prescription medicines, based on their ingredients and/or their therapeutic indications (intended uses).

Registered medicines in the Australian Register of Therapeutic Goods (ARTG) are assigned an 'AUST R' identification number that must be displayed on the label.

Complementary medicines must undergo a full TGA pre-market evaluation of their safety, quality, and efficacy and be registered in the ARTG if at least one of the following applies:

• they do not solely comprise of ingredients allowed for use in listed medicines or assessed listed medicines
• they contain an ingredient or ingredient component that is subject to the conditions of a Schedule or relevant appendix to the Poisons Standard (other than Schedules 4, 8, 9)
• they have higher level indications that are not permitted for use in listed or assessed listed medicines. High level indications refer to prevention, cure or alleviation of a serious form of a disease, ailment, defect or injury (i.e. restricted representations).
• they are required to be sterile.

Depending on the level of risk, registered complementary medicines can be sold as:

• General sales medicines: sold in pharmacies and stores such as supermarkets e.g. some fibre supplements.
• Pharmacy medicines: sold in pharmacies without a pharmacist’s advice e.g. high-dose iron supplements.
• Pharmacist-only medicines: sold in pharmacies with a pharmacist’s advice on their use e.g. high-dose vitamin D supplements.

Registered complementary medicines can include a ‘TGA assessed claim’ on their label and other advertising indicating the TGA has assessed the evidence for the medicine’s indications.