THE complementary medicines (CM) sector has hailed the introduction of new rules around claims that products are locally manufactured, as the outcome of changes proposed to the Australian Consumer Law (ACL) to give CMs greater access to Australian origin claims.
The long-running saga follows an adverse court ruling just over 12 months ago, in which Nature's Care was denied permission to label its capsules "Made in Australia".
The company's licence renewal with the Australian Made Campaign Limited was rejected, meaning it was not allowed to use the associated kangaroo logo for its Fish Oil 1000+ Vitamin D3 product which, although manufactured from primarily imported ingredients was "substantially transformed" during its Australian manufacturing processes.
Subsequently a governmental taskforce was established, with the government releasing regulatory impact statements and seeking input from States and Territories.
New regulations, designed to create greater access to an Australian origin claim for locally manufactured complementary medicines passed the Federal Executive Council, and were signed by the Governor General last Fri.
Once they are posted on the Federal Register of Legislation, expected sometime this week, the new regulations will become effective, including details of an example process undertaken for items that meet the "substantial transformation test" under the ACL.
If a product has had "at least the last step in the manufacture of the dosage form occur at premises in Australia" its manufacturer can seek to license the Australian Made, Australian Grown logo.
It is not mandatory to claim Australian origin, with the new regulations an interim step providing immediate access to an Australian origin claim.
An ongoing solution will require a change to the ACL which is also supported by the various States and Territories, according to Warren Knight of the Department of Industry, Innovation and Science, who updated the CM sector on the changes earlier this week.
Complementary Medicines Australia CEO, Carl Gibson, said the new regulations was "the best Christmas present for our industry...we export over $1 billion of complementary medicines, and restoring the 'Made in Australia' claims will be a real boost for our manufacturing sector".
The above article was sent to subscribers in Pharmacy Daily's issue from 18 Dec 19
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