Enviro Tech Holdings and company officers ordered by Federal Court to pay $96,000 for unlawful importation of surgical face masks

TGA

The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.

In December 2020, the TGA issued an infringement notice to Enviro Tech for $13,320. As the company did not pay the fine, court proceedings were commenced.

The Court found that Enviro Tech breached a condition of a special regulatory exemption in place during the early stages of the COVID-19 pandemic by importing surgical face masks that were not for supply to the National Medical Stockpile and were also not included on the Australian Register of Therapeutic Goods (ARTG).

In addition to fining the company, the Court ordered two company officers to each pay $8,000 for aiding, abetting, counselling, or procuring contraventions of the Therapeutic Goods Act 1989.

In making her orders, Justice Hespe stated: “Ignorance of the requirements of the Therapeutic Goods 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.”

The Court also highlighted the importance of the regulation of face masks: “… by circumventing the requirements of the Therapeutic Goods Act, the effect of the contravening conduct was to create a risk of harm to public health during the COVID-19 pandemic.”

Enviro Tech has also been ordered to pay the Department of Health and Aged Care’s costs of the court proceedings.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

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