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Pathways for complementary medicine products

27 March 2018

This tool will assist potential sponsors of complementary medicines to determine the most suitable pathway to enter their product in the Australian Register of Therapeutic Goods (ARTG).

On 19 March 2018, a new assessed listed medicines pathway was introduced. Assessed listed [AUST L(A)] medicines differ from listed (AUSTL) medicines in that they can make intermediate level indications. Assessed listed medicines are entered in the ARTG following self-certification by the applicant of the safety and quality of the product and TGA pre-market assessment of the efficacy evidence supporting the proposed indications.

This tool assists potential and existing complementary medicine sponsors to determine which of the three pathways is most suitable for their product.

Make sure you understand the overview of the regulation of complementary medicines in Australia before you start.

If you are unsure if your product is likely to be a food, cosmetic or medicine, use the Is my product a therapeutic good? decision tool under SME Assist.