Complementary Health

As a registered certification trademark, the Australian Made, Australian Grown (AMAG) logo can only be used on products that are registered with the Australian Made Campaign and meet the criteria set out in the Australian Consumer Law and the Code of Practice.

The use of the AMAG Logo on Complementary Healthcare Products may be approved when a product underwent its last substantial transformation in Australia. This applies even if the product contains imported ingredients.

The substantial transformation provisions that applies to these claims in Section 255 of the Competition and Consumer Act 2010 (‘the CCA’) are:

• (b) as a result of one or more processes undertaken in that country, the goods are fundamentally different in identity, nature or essential character from all of their ingredients or components that were imported into that country; or
• (c) the goods underwent in that country one or more processes prescribed by the regulations.

Most complementary medicines in Australia are listed on theAustralian Register of Therapeutic Goods (ARTG) and seek to make these claims under item (c) of the above. Section 92 AA of the Competition and Consumer Regulations 2010 (‘the CCA’) prescribes a process that medicines have undergone in Australia to be substantially transformed in Australia.

The prescribed process applies to medicines that are complementary medicines, within the meaning of the Therapeutic Goods Regulations 1990, and are either: (a) listed goods; or (b) registered goods.

The process is the carrying out of the last step (except one covered by subregulation (4)) in the manufacture of the dosage form of medicines that:

• occurs at premises in Australia; and
• is authorised by a licence to occur in relation to those medicines at those premises.

Subregulation (4) covers the following steps which do not qualify as the last step in the manufacture of the dosage form: 

1. covering of the dosage form of medicines in containers; 
2. packaging of the dosage form of medicines; 
3. labelling of the dosage form of medicines; 
4. storage of the dosage form of medicines (whether in packaging or not); 
5. testing of the dosage form of medicines; 
6. release for supply of the dosage form of medicines. 

In summary, Australian complementary medicines that are listed or registered on the ARTG and whose last step in the manufacture of the dosage form that is accepted and prescribed by Section 92AA of the Regulations, may make a made in Australia claim if it has occurred at premises in Australia that is authorised by a TGA license to occur in relation to those medicines at those premises.

Applications to use the Australian Made logo on complementary medicines will need to provide the following information:

• L or R number for each product
• The dosage form, the name of manufacturer of the dosage form
• The full product name including the brand (as it appears on the label).
• A copy of the ARTG certificate for each product

Find out more about country of origin claims at the ACCC website.