Therapeutic Goods (Excluded Goods) Determination 2018 is formulated by Therapeutic Goods Administration under section 7AA of Therapeutic Goods Act 1989 which excludes a number of goods from the operation of the 1989 Act. The new determination takes effect on 1 October 2018.

Key elements of the new determination are highlighted below:

1. Cosmetic Standard 2007’s relevant requirements of therapeutic goods have been reproduced directly in the new determination. Namely cosmetic products that are imported, exported or supplied in Australia in a manner consistent with the terms of exclusion included in the previous standard will continue to be exempted from stringent regulatory requirements of therapeutic goods under the new TGA exclude goods determination. Stakeholders’ obligations in respect of cosmetic ingredients and cosmetic products are essentially the same as before.
2. Topical antiperspirants and ear candles are currently excluded from therapeutic goods regulatory framework. Chemicals in these products are now subject to registration obligations stipulated under the Industrial Chemicals (Notification and Assessment) Act.