Court proceedings initiated for alleged unlawful importation of face masks

The Therapeutic Goods Administration (TGA) has commenced proceedings in the Federal Court against Enviro Tech Holdings Pty Ltd (Enviro Tech), and its executive officers (Connie and Jerry Triantos) for the alleged unlawful importation of surgical face masks.

Under a legal exemption introduced in March 2020 to allow Australia to rapidly respond to the COVID-19 pandemic, certain medical devices, including surgical face masks, were able to be imported without first being included on the Australian Register of Therapeutic Goods (ARTG).

However, this only applied to medical devices supplied to the National Medical Stockpile under a contract with the Department of Health, which maintains the stockpile.

It is alleged that Enviro Tech imported surgical face masks without the required contract and without including them on the ARTG at the time of import.

As such, the TGA contends that Enviro Tech has not complied with provisions of the Therapeutic Goods Act 1989 (the Act) that are intended to ensure medical devices imported into Australia are safe and perform as intended by the manufacturer.

In December 2020, Enviro Tech was issued with a $13,320 infringement notice for the alleged breach. However, as Enviro Tech did not pay the infringement notice, further legal action is now being taken.

Further information about the alleged unlawful importation is available in the following documents:

• Concise statement (pdf,359kb)
• Originating Application (pdf,367kb)

Background

In March 2020, a delegate of the Minister for Health made the Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (Cth).

The exemption supported Australia's rapid response to the COVID-19 pandemic by allowing the importation of personal protective equipment for inclusion in the National Medical Stockpile, maintained by the Department of Health, without first being included on the ARTG, providing the supplier had a contract with the Department for their supply.

The exemption has now expired. More information is available at Emergency COVID-19 exemptions end for ventilators and personal protective equipment.

TGA takes action for breaches of the Act

Australia's regulatory scheme for therapeutic goods is critical to the health and safety of consumers, and the TGA has the power to investigate and take action in relation to alleged unlawful activities.

The Act imposes a range of sanctions and penalties, including for persons who unlawfully import therapeutic goods. The range of compliance and enforcement tools available include substantial fines and criminal or civil court action.

The TGA reminds sponsors that it can, and will, take action to enforce unpaid infringement notices to ensure the continued integrity of the therapeutic goods compliance and enforcement framework.

Contact for the media

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400