New Country of Origin Regulations for Complementary Medicines
In December 2019, new regulations were introduced to once again allow manufacturers and sponsors of Complementary Medicines to make an “Australian Made” claim on their products. Complementary Medicines are therapeutic goods that are listed or registered with the Therapeutic Goods Administration (TGA).
The new regulations are a welcomed change as they have created greater access to Australian origin claims and are the result of a series of steps taken by the Government to review and evaluate the impact of the 2017 consumer law changes on the complementary healthcare sector. These steps included:
+ Establishment of a Complementary Medicine Taskforce resulting in the Federal Government announcing it would 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;
+ The Department of Industry, Innovation and Science (DIIS) released a Regulatory Impact Statement (RIS) on the proposed changes to country of origin claims in the complementary medicines sector. This was an important step in the process of changing the Australian Consumer Law (ACL). The RIS discussed the various options to assist the complementary medicines sector to regain access to the logo;
+ DIIS published a Decision RIS proposing to implement changes whereby complementary medicines manufactured in Australia would be eligible to use the Australian Made logo in addition to a visual representation of the proportion of ingredients that are imported.
As this would require a change in the ACL and creation of additional rules, an interim measure was introduced allowing labels to use the Australian Made logo. Further changes to the labelling of products are therefore, anticipated.
Medicines compliant with the following requirements are now covered by the definition of “substantial transformation”:
+ Goods must be complementary medicines within the meaning of the Therapeutic Goods Regulations 1990, and must be listed or registered with the TGA;
+ The last step in the manufacture of the dosage form must be carried out in a facility in Australia which is licensed to carry out that step;
+ The ‘last step’ does not include any of the following processes:
o covering of the dosage form of medicines in containers (example: blister packaging);
o packaging of the dosage form of medicines;
o labelling of the dosage form of medicines;
o storage of the dosage form of medicines (whether in packaging or not);
o testing of the dosage form of medicines;
o release for supply of the dosage form of medicines.
The ACCC has also withdrawn its guidance on ‘Country of Origin labelling for Complementary Medicine’.
Although making a country of origin claim remains voluntary for complementary medicines, many markets highly regard the well-known, green and yellow “Australian Made” logo. It is proven that consumers are willing to pay premium prices for Australian Made products due to the high value and trust placed on Australian manufacturing under TGA regulations with world-class testing and manufacturing conditions.
Author: Aastha Mathur Shan
Vitex Pharmaceuticals Pty Ltd