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Therapeutic Goods (Excluded Goods) Determination 2018 explanatory notes

27 September 2018

The Therapeutic Goods Administration (TGA) has made a new determination under section 7AA of the Therapeutic Goods Act 1989 (the Act) which excludes certain goods from the operation of the Act. The instrument takes effect on 1 October 2018.

There are three key elements of the new section 7AA instrument that are highlighted below:

  1. antiperspirants and ear candles are now excluded from the operation of the Act.

The outcome is a partial implementation of the outcomes of the options for 'future regulation of low risk products' and announced as agreed by Government on 21 June 2018.

  1. therapeutic goods which are presently declared not to be therapeutic goods in the existing Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 (EGO), are now excluded under the new section 7AA instrument:
    • goods specified in sections 4 (a) - (n) of the EGO
    • goods specified in item 7 of Table 1 of section 5 of the existing EGO
    • packs and kits specified in item 11 in Table 1 of section 5 of the EGO, and
    • goods specified in section 6 of the EGO.

This measure will have no regulatory impact on affected stakeholders, as the goods are presently considered not to be therapeutic goods and therefore currently not subject to the operation of the Act.

  1. the requirements of the Cosmetics Standard 2007 (Cosmetics Standard) relating to a number of therapeutic goods have been reproduced directly in the new determination, rather than incorporating the Cosmetics Standard by reference as is currently the case in the EGO.

The Cosmetics Standard currently specifies requirements for certain products that meet the definition of therapeutic goods but are excluded from TGA regulation as a consequence of the current EGO (section 6 refers). The Cosmetic Standard will sunset on 1 October 2018. The new section 7AA instrument reproduces the relevant content of the Cosmetics Standard in the new determination to maintain continuity. TGA still has oversight of products that do not meet the requirements of the exclusion - this measure will maintain the status quo in relation to these products.

Next steps

Major industry groups have been informed of these developments. We will be writing to affected sponsors of antiperspirants and ear candles regarding the next steps for products previously captured by the operation of the Act.

Further information

Contact the TGA Regulatory Reforms Team for further information.