Australian Made Complementary Medicines

UPDATE – JANUARY 2020

New regulations came into force in December 2019 which allow manufacturers of complementary medicines to once again make an “Australian Made” claim for their products.

The Competition and Consumer Amendment (Australian‑made Complementary Medicines) Regulations 2019 can be viewed here: https://www.legislation.gov.au/Details/F2019L01627.

The regulations apply to complementary medicines which are listed or registered with the Therapeutic Goods Administration (TGA) for which the last step in the manufacture of the dosage form is carried out at a facility in Australia licensed to carry out that step. Such medicines are considered to have been substantially transformed in Australia, and therefore can be described as “Australian Made”.

This will not apply to medicines which have only been packaged, labelled, tested or released in Australia.

The Australian Competition and Consumer Commission (ACCC) has withdrawn its guidance on country of origin claims for complementary medicines to reflect the new Regulations. In addition, the Australian Made Campaign Limited (AMCL) has withdrawn its guidelines for this type of product.

Licensees and former licensees to the Australian Made Logo may now re-apply to the AMCL to use the logo on products which previously did not qualify.

See Applying for a License

Further Changes ForeshadowedCompanies should be aware that further changes to this policy may occur in the near future. The Department of Industry has advised that “These regulations represent an interim step in restoring Australian origin claims for complementary medicines. They will be followed by an ongoing solution requiring a change in the Australian Consumer Law and the creation of rules to acknowledge the proportion of Australian ingredients on a label if a product is claimed to be Australian under those new laws. The ongoing changes are not expected to be implemented until the second half of 2020.”

If these anticipated changes to the law are implemented, companies may be required to make further changes to the labelling of their products.

CMA’s 2020-21 Pre-Budget Submission to Government has recommended that the business certainty provided in the updated Australian‑made Complementary Medicines Regulations now needs to remain stable for a reasonable period of time without further label amendments posed on a compliant industry.

See CMA’s 2020-21 Pre-Budget Submission here.

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