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TGA fines COVID-19 speedy antigen take a look at provider greater than $100,000

by Novigo News
June 23, 2022
in Australia
Reading Time: 2 mins read
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The Therapeutic Items Administration mentioned it has issued eight infringement notices to Hough Pharma Pty Ltd.

The TGA mentioned the fines had been issued for “allegedly failing to offer info” to the federal government company to “exhibit the protection and efficiency of three COVID-19 speedy antigen checks”.

A provider of COVID-19 speedy antigen checks has been hit with a number of fines totaling $106,560. (Tanya Macheda/File)

“All sponsors of medical units authorized by the TGA are required underneath the Therapeutic Items Act 1989 to offer this proof to the TGA when requested and inside the specified timeframe,” the TGA mentioned in a press release.

“This helps guarantee medical units are protected and carry out suitably for his or her meant objective.”

The federal government company additionally alleged “a scarcity of buyer help has been reported by shoppers and verified by TGA investigations”.

Nonetheless Hough Pharma’s managing director, Jackson Hough, instructed the Sydney Morning Herald and The Age the corporate had constantly offered information to the regulator.

“Hough Pharma has regularly offered efficacy, security and variant information to the TGA to exhibit our merchandise successfully detect COVID-19 and its variants,” he instructed the newspapers.

Hough additionally added that the corporate rejected allegations of a scarcity of customer support.

“We function a 1800 quantity, along with e mail and SMS response choices which can be offered from 7am–9 pm, seven days per week,” he mentioned in a press release to the newspapers.

9.com.au has contacted Hough Pharma and the TGA for remark.



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