16 September 2020
The Australian Government is currently inviting consumers and industry participants to provide feedback on key provisions of the proposed Information Standard for manufacturers of complementary medicines. This Information Standard will also set out the labelling requirements.
The period of consultation will close on 24 September 2020.
The introduction of this Information Standard is in response to the Australian Government's changes to country of origin labelling laws in 2017. Whilst these changes were targeted towards the food industry, it also unintentionally captured complementary medicines and prohibited "Made in Australia" claims for medicines that were manufactured using imported products.
As an interim measure, the Competition and Consumer Regulations 2010 (Cth) was amended in December 2019 to allow Australian manufacturers of complementary medicines to claim that their products are "Made in Australia" in instances where the products were "substantially transformed" in Australia. This includes where the last step in the manufacture of the medicine occurs at a premises in Australia and is authorised by a licence to occur in relation to those medicines at those premises. However, this does not include:
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covering of the medicines in containers
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packaging of the medicines
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labelling of the medicines
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storage of the medicines (whether in packaging or not)
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testing the medicines
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release for supply of the medicines
Further legislative changes are intended to be implemented in relation to country of origin labelling for complementary medicines. These proposals include that complementary medicines making a "Made in Australia" claim based on the new regulations must display a bar chart on the packaging of the complementary medicine apportioning the percentage of Australian ingredients in the product. The proposed Information Standard is intended as a guide for manufacturers of complementary medicines on the Government's labelling requirements for country of origin claims.
The proposed changes will not apply to complementary medicines claiming "Made in Australia" based on the rules that existed prior to 18 December 2019.
For further information, please contact:
Katrina Dang, Bird & Bird
