TGA’s new penalty framework gets dental industry tick


Proposed reforms that will strengthen the Therapeutic Goods Administration’s ability to better deal with instances of illegal supply have been strongly endorsed by the Australian Dental Industry Association (ADIA).

“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,” said Troy Williams, ADIA chief executive officer.

“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.”

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 was widely 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.

“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,” Williams said.

“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.”

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