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:
antiperspirants and ear candles are now excluded from the operation of the Act.
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.
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.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.