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Registered complementary medicines

25 March 2013

Registered complementary medicines are considered to be of relatively higher risk than listed medicines, based on their ingredients or the indications made for the medicine. Registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to being accepted on the Australian Register of Therapeutic Goods (ARTG) and able to be marketed. Medicines registered on the ARTG are assigned a unique AUST R number, which must be displayed on the medicine label.

How to register a complementary medicine on the ARTG

An applicant seeking registration of a complementary medicine is required to submit a detailed dossier of information to the TGA for evaluation. This data must establish that the proposed medicine is of appropriate quality, safety and efficacy before it is approved for inclusion on the ARTG.

Refer to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines for information on the data package required for an application for a registered medicine. Also refer to the Applications for registered complementary medicines for information on lodging an application for a registered complementary medicine.

If you are a sponsor who has no previous experience registering a medicine in Australia, you may wish to seek the services of an Australian regulatory affairs consultant.