UPDATE – 16 SEPTEMBER 2020
New regulations came into force in December 2019 which allowed manufacturers of complementary medicines to once again make an “Australian Made” claim for their products.
The regulations apply to complementary medicines which are listed or registered with the TGA for which the last step in the manufacture of the dosage form is carried out at a TGA-licensed facility in Australia. Such medicines are considered to have been substantially transformed in Australia, and therefore can be described as “Australian Made”.
As previously advised, the Federal Government is now moving to introduce new requirements for manufacturers of complementary medicines to declare the percentage of Australian content in their products.
The government is seeking feedback on the details of the proposal. A discussion paper and online survey are available here. The closing date for submissions is 24 September.
AMCL strongly recommends that if you are affected by this proposal you should read the discussion paper and make your views known by responding to the survey.
UPDATE – 7 JANUARY 2020
New regulations came into force in December which allow manufacturers of complementary medicines to once again make an “Australian Made” claim for their products.
The regulations can be viewed here: https://www.legislation.gov.au/Details/F2019L01627.
The regulations apply to complementary medicines which are listed or registered with the TGA for which the last step in the manufacture of the dosage form is carried out at a facility in Australia which is 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 does not apply to medicines which have only been packaged, labelled, tested or released in Australia.
The ACCC has withdrawn its guidance on country of origin claims for complementary medicines and AMCL has withdrawn its guidelines for this type of product.
Licensees and former licensees may now re-apply to use the Australian Made logo on products which previously did not qualify.
However, companies should be aware that further changes may be on the horizon. 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.
UPDATE - 31 OCTOBER 2019
On October 3, the Department of Industry, Innovation and Science released a Regulatory Impact Statement (RIS) on proposed changes to country of origin claims in the complementary medicines sector and requested submissions from interested parties.
Submissions have now closed. AMCL made a submission and we trust that licensees and former licensees have also taken this opportunity to make their position clear.
The Department has stated that it is now “reviewing and analysing the submissions we received. This feedback will inform consultation with the Commonwealth, state and territory governments, which will inform the Decision RIS.”
Ultimately we expect that this consultation process will result in changes to the law which will allow complementary medicines manufactured in TGA-licensed facilities in Australia to once again be able to make an Australian Made claim.
Until then, we want to stress that all licensing decisions made by AMCL as part of its review of licensed complementary medicines remain in force. If some or all of your products have been de-licensed as a result of AMCL’s review, you should no longer be selling products carrying the Australian Made logo. In addition, you should not be using the Australian Made logo in advertising and other marketing material for these products. This includes product images on websites or retail platforms which show the Australian Made logo on the product.
UPDATE - 11 OCTOBER 2019
The Department of Industry, Innovation and Science has released a Regulatory Impact Statement (RIS) on proposed changes to country of origin claims in the complementary medicines sector.
The RIS is an important step in the process of changing the Australian Consumer Law so that companies who manufacture complementary medicines in TGA-licensed facilities in Australia will once again be able to claim that their products are “Made in Australia”.
The RIS can be found at https://consult.industry.gov.au/cool-taskforce/clarifying-eligibility-for-origin-claims/
The Department is asking for submissions from interested parties. There are questions for manufacturers of complementary medicines on page 50 - 54 which can be used as the basis of a submission. Submissions close 30 October.
UPDATE - 5 AUGUST 2019
AMCL has now been advised by Department of Industry representatives that implementing the Government’s preferred policy option will require a change to the Australian Consumer Law (ACL) as well as a new regulation under that law. Changes to the ACL require agreement of the states and territories through the COAG (Council of Australian Governments) Consumer Affairs Forum.
If the changes are approved by COAG, it is unlikely that they could be implemented before early 2020. There is also a possibility that COAG will not approve the proposal.
As a result of this latest development, we want to stress that all licensing decisions made by AMCL as part of its review of licensed complementary medicines remain in force until such time as the government’s proposed changes become law.
If some or all of your products have been de-licensed as a result of AMCL’s review, you should no longer be selling products carrying the Australian Made logo. In addition, you should not be using the Australian Made logo in advertising and other marketing material for these products. This includes product images on websites or retail platforms which show the Australian Made logo on the product.
You should also advise your distributors and retailers that they should update online listings and advertising material in line with this.
UPDATE - 05 APRIL 2019
The Australian Made Campaign Ltd (AMCL) welcomes today’s announcement from the Federal Government that it will introduce changes which would see complementary medicines manufactured in TGA-approved Australian production facilities qualify to carry a ‘made in Australia’ claim and the Australian Made logo.
However we would stress that at this point in time, nothing has changed. The announcement signals the government’s intention to make changes which may or may not eventuate.
At this time, AMCL is seeking more clarity around:
- the detail of the proposed legal instrument - presumably this will take the form of regulations under the Australian Consumer Law - and the degree of consultation required
- the timeframes associated with the proposed changes - obviously complicated by the impending federal election
- the ACCC’s position in relation to possible enforcement action in the intervening period.
Licensing decisions made by AMCL as part of its review of licensed complementary medicines remain in force until such time as the government’s proposed changes become law.
UPDATE - 31 JANUARY 2019
On 8 December 2018, the Federal Government announced the establishment of a taskforce to “review the impact of recent consumer law changes on the complementary healthcare sector”. The announcement from Minister for Industry, Science and Technology Karen Andrews can be found here. The taskforce, which will consult with industry, consumers, AMCL and government bodies, is expected to report back to government in late February 2019.
The Taskforce is inviting industry to participate in a short survey to canvas their views and further inform the Taskforce on this matter. The intention is to capture the views of a range of industry stakeholders, with the Taskforce welcoming input from AMCL licensees.
The survey includes questions about your business, your complementary medicine manufacturing, import and export activities, and how recent legislative changes have impacted your business.
Australian Made encourages licensees to complete the survey before the closing date of 12 February.
UPDATE - 25 JANUARY 2019
In June last year AMCL began reviewing licensed complementary health products to ensure that these products complied with AMCL’s new guidelines. These guidelines are consistent with the ACCC’s guidance for the sector published in March 2018 following changes to the country of origin provisions of the Australian Consumer Law. You will have already been contacted by our Project Officer, Mr Hein Ling, regarding your products.
In October, we advised you that this review project had been placed on hold pending the outcome of a Federal Court case brought by Nature’s Care Manufacture Pty Ltd against AMCL in which Nature’s Care was seeking a ruling that a particular product (Fish Oil + Vit D3 soft gel capsules) was substantially transformed in Australia.
We can now report that the judge’s decision was that the product in question was not substantially transformed in Australia. The full judgment can be found here.
As a result of this decision, we now advise that AMCL has cancelled all licences for products of this nature - that is, soft gel capsules containing imported marine oils (fish oil, krill oil, squalene, salmon oil, etc.) -with immediate effect.
You must no longer sell any affected products bearing the Australian Made logo, or use the logo to market or promote these products, and you must remove the logo from any affected products and marketing materials in your possession. This includes product images on websites where the logo is clearly visible in the image. Please note AMCL is not requiring you to remove the logo from product which has already been sold to retailers.
In addition, we will be contacting you to finalise the review of your other products if this has not been completed.
As a further result of the court’s decision, we are now unable to provide an extended deadline for removal of the logo from other non-compliant products.
We regret that this has become necessary. Throughout this process, AMCL has worked hard to assist licensees with the transition process and to provide reasonable timelines for changes to be implemented. Unfortunately this is no longer possible. We advise all licensees to act promptly in order to avoid possible action on the part of the ACCC.
UPDATE - 30 OCTOBER 2018
Since June this year, AMCL has been reviewing licensed complementary health products to ensure compliance with AMCL’s new guidelines which are consistent with the ACCC’s guidance for the sector. You may have been contacted by our Project Officer, Mr Hein Ling, regarding your products.
In a new development, AMCL has been named as the respondent in a Federal Court case brought by licensee Nature’s Care Manufacture Pty Ltd. Nature’s Care is seeking a ruling on whether one of its products (Fish Oil 1000 + Vitamin D3 soft gel capsules) is substantially transformed in Australia. A hearing in this matter is scheduled for 26 November 2018.
As a result of AMCL’s inclusion in this court case, the Board of AMCL has now directed us to suspend our review process until further notice.
We are also lifting restrictions on affected licensees renewing their licences, pending the outcome of the court case. If your licence has expired and you wish to renew, please call our office on 1800 350 520 and speak to Suzana or Lynne to arrange a renewal invoice.
We understand that these events have caused considerable inconvenience and uncertainty for licensees, however AMCL has had little choice in the light of the changes to the law and the ACCC’s position. We will review our position based on the outcome of the court case and will keep you informed of any new developments.
UPDATE - 08 JUNE 2018
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 firstname.lastname@example.org.
Enquiries regarding the ACCC’s guidelines should be directed to the ACCC on 1300 302 021.
Country of origin labelling for complementary healthcare products (ACCC)
Pharmaceutical & complementary healthcare products - compliance policy (AMCL)
Country of origin claims and the Australian Consumer Law (ACCC)