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Changes to compliance criteria - pharmaceutical and complementary health products

Changes to compliance criteria - pharmaceutical and complementary health products

 

In February 2017, the Federal Government made changes to the law relating to country of origin claims. For ‘Made in Australia’ claims, the 50% cost of production test was removed and the definition of ‘substantial transformation’ was changed.

As a result of this, Australian Made Campaign Limited (AMCL) updated the rules for using the Australian Made logo to ensure consistency with the law. These changes were approved in August 2017.

In March 2018, the ACCC produced a guidance document on country of origin claims for complementary health products.  This guidance is also relevant to pharmaceutical, medical and some veterinary products. A copy can be downloaded here.

The new definition of ‘substantial transformation’ focuses more on the imported content of a product than the previous definition. Some products which previously met the substantial transformation test will no longer do so, meaning that they will no longer qualify to carry the Australian Made logo.

As an example, the ACCC has expressed the view that encapsulating imported active ingredients (whether in hard or soft gel capsules) is not sufficient to support a ‘Made in Australia’ claim.

However, the ACCC believes that tableting imported ingredients may be sufficient, where the raw materials have been blended, granulated and compressed in Australia.  

It is important to note that this document represents the ACCC’s interpretation of the law. It does not constitute legal advice. You may still make a ‘Made in Australia’ claim on your products if you believe that the claim you are making is a true claim which you can defend in a court of law. You should also note that there is no legal requirement for complementary medicines to carry a country of origin label.

However, in light of this new advice released by the ACCC, AMCL needs to change its own guidelines on which products qualify to carry the Australian Made logo. It has always been our policy that our interpretation of the law, in particular the ‘substantial transformation’ test, should be consistent with the ACCC’s.

Accordingly, we have prepared a set of guidelines for assessing products to carry the Australian Made logo. These guidelines can be downloaded here.

 

INFORMATION FOR LICENSEES

AMCL has appointed Hein Ling as our Project Officer - Complementary Health. Hein will be contacting affected licensees about reviewing their products.

During this period, you will not be able to renew your licence online until the review of your products has been completed.  Please be assured that we will not cancel your licence if your renewal becomes overdue for this reason.

It is important that the logo is removed from all products which no longer comply within an acceptable timeframe. We have set 1 July 2019 as the deadline by which the packaging and labelling changes must be completed.

While AMCL will not take action against licensees during the period from now to 1 July 2019 for using the logo on products which may no longer comply, there is no transition period attached to the changes to the law.  Therefore it is in your own interest to make the necessary changes as quickly as possible.

AMCL understands that these changes may have a significant impact on your business. We are committed to working with all of our licensees to assist with the transition.

Please direct any enquiries to Hein Ling on hein.ling@australianmade.com.au.

Enquiries regarding the ACCC’s guidelines should be directed to the ACCC on 1300 302 021.

 

ADDITIONAL INFORMATION

Country of origin labelling for complementary healthcare products (ACCC)
DOWNLOAD

Pharmaceutical & complementary healthcare products - compliance policy (AMCL)
DOWNLOAD

Country of origin claims and the Australian Consumer Law (ACCC)
DOWNLOAD

Country of origin food labelling (ACCC)
DOWNLOAD

Country of origin labelling and the dairy industry (ACCC)
DOWNLOAD