Australia's Complementary Medicine Manufacturers
Re-tool In Response to Coronavirus
Case Study: Our sector has been swift in responding to the national call to arms for businesses to regear manufacturing in order to fill the shortage of medical equipment and hygiene products, such as hand sanitisers, amid the coronavirus pandemic.
Brauer has been providing Australians with natural health products for over 90 years. Their TGA-licensed manufacturing facility operates in accordance with the principles of Good Manufacturing Practice (GMP) out of the Barossa Valley and has seen significant growth due to exports in the past two years, especially for its baby and children products.
With the novel Coronavirus (COVID-19) situation creating significant shortages of hand sanitiser, made worse by the limited supply of ethanol and suitable packaging, Brauer worked collaboratively with several other South Australian manufacturers retooling within just two weeks to produce hand sanitiser to WHO standard.
Brauer’s first shipment of 30,000 units left for Services Australia, the Federal Government agency that supplies Centrelink. Brauer plans to continue supplying essential hygiene products for as long as is required. Brauer’s staff took great pride in helping to do their part for the community and is to be congratulated.
“This is an extraordinary opportunity for our advanced manufacturing sector to not only diversify their supply but produce incredibly important products for Australia in its time of need, said Carl Gibson, CEO of Complementary Medicines Australia (CMA).
“We’re in a unique position to manufacture essential products – with the required federal licences, access to raw materials and critical expertise – and so more Australian complementary medicine manufacturers are following suit and making hand sanitiser a production focus.”
“We are pleased to be working with Government on these initiatives and it is encouraging to see that Austrade are now standing up the International Air Freight Assistance Mechanism to support outgoing high value exports and prioritise inward shipping of medical supplies” he said.
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.
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.