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02 Jun 2017 | Press Release

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TGA's New Penalty Framework Gets Dental Industry Tick

Regulatory Affairs TGA

Proposed reforms that will strengthen the Therapeutic Goods Administration's (TGA) ability to better deal with instances of illegal supply have been strongly endorsed by the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of dental products.


"For some years ADIA has been calling on the Australian Government to allow the TGA to better deal with low-level breaches of its legislation. The proposed reforms that will empower the TGA to issue infringement notices in the case of illegal supply of dental products will not only enhance patient safety, but preserve the integrity of the TGA's regulatory framework," said Troy Williams, ADIA Chief Executive Officer.

The challenge before was that when the TGA was confronted with clear and irrefutable evidence of illegal supply, it could only issue an infringement notice where the product supplied illegally would likely harm or injure a person. This has widely been recognised as an inappropriate requirement that, in effect, made it difficult for the TGA to effectively enforce its legislation insofar as low level breaches occurred. Such low-level breaches may take the form of a person buying dental product online then using this product on patients without first seeking TGA market authorisation.

"The proposed reforms will provide the TGA, through issuing of infringement notices, with access to sanctions to appropriately respond to the full range of offences. From dealing with repeated minor breaches through to serious non-compliance the TGA will have new powers to more efficiently and effectively apply a penalty. ADIA is fully supportive of this outcome," Mr Williams said.

The proposed reforms follow sustained advocacy on the part of ADIA to ensure that the legislation provides mechanisms to enhance patient safety and preserve the integrity of the medical device regulatory framework. In 2011 ADIA's representations to a parliamentary review of the regulatory framework for the approval of medical devices resulted in the Senate Community Affairs Committee recommending that the TGA carry out an investigation to ascertain whether importation of medical devices via the internet is adequately regulated. Since then ADIA has maintained pressure on successive governments to enhance patient safety.

"This is a great outcome for the entire sector. A regulator that's able to effectively deal with instances of illegal product supply helps strengthen confidence in the safety of dental products supplied in accordance with the TGA's legislation," Mr Williams concluded.

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