Another rapid antigen test sponsor fined by the TGA

This article was updated at 9.40 am on Monday 15 August to include quotes provided by 2San.

Five infringement notices totalling $66,600 have been issued to 2San Pty Ltd for allegedly failing to provide the Therapeutic Goods Administration (TGA) with evidence demonstrating the ongoing minimum level of sensitivity for two of its COVID-19 rapid antigen tests.
 
The multiple infringement notices were issued for alleged ‘serial non-compliance’ in not providing the information by the required deadlines, despite TGA officers reportedly contacting the company on several occasions over a two-month period to ‘remind them of their obligations’.
 
The TGA says the compliance action serves as a reminder to sponsors to take their obligations seriously.
 
‘Suppliers of products such as COVID-19 tests must meet their ongoing responsibilities with respect to post-market vigilance and monitoring,’ a public statement from the regulator read.
 
‘All sponsors of medical devices approved by the TGA are required by law to provide this evidence … when requested and within the specified timeframe.
 
‘This helps ensure medical devices are safe and perform suitably for their intended purpose.’
 
A 2San spokesperson told newsGP the company has contacted the TGA since the infringement notice was published, with a view to resolving the matter ‘as soon as possible’.
  
‘2San has been in contact over several months – in writing and via phone – regarding some extra information that the [TGA] was requesting … [and] believes it has fully complied with the provision to the TGA of the requested information,’ they said.
 
‘We agree with the TGA that companies need to take compliance obligations seriously, and further add that engagement between the regulator and the sector needs to be fair at all times.
 
‘The Federal Government has outlined a process through which infringement notices can be withdrawn, and we have commenced that process.’
 
On the same day that the fines were announced, the TGA also revealed that Melbourne-based company Enviro Tech Holdings has been ordered by the Federal Court to pay $80,000 for the unlawful importation of surgical face masks.
 
The TGA release says court proceedings were commenced after the company failed to pay a $13,320 infringement notice issued in December 2020.
 
The Court subsequently found that Enviro Tech had breached a condition of a special regulatory exemption that was in place during the early stages of the pandemic, by importing surgical face masks that were not for supply to the National Medical Stockpile, nor included on the Australian Register of Therapeutic Goods (ARTG).
 
In addition to fining the company, the Court ordered two company officers to each pay $8000 for aiding, abetting, counselling, or procuring contraventions of the Therapeutic Goods Act 1989.
 
‘The effect of the contravening conduct was to create a risk of harm to public health during the COVID-19 pandemic,’ Justice Lisa Hespe wrote in her judgement.
 
‘Ignorance of the requirements of the [Act] and regulations, and inexperience in dealing with the regulatory regime, are not an excuse.
 
‘Those who wish to engage in business involving therapeutic goods have a responsibility to be aware of the applicable statutory scheme and to comply with the relevant regulatory requirements.’
 
In addition to the fine, Enviro Tech has also been ordered to pay the Department of Health and Aged Care’s legal fees.
 
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COVID-19 face masks rapid antigen tests TGA Therapeutic Goods Administration