Fines up to $26.6k doled out


Five companies and one Melbourne woman have been fined for alleged unlawful importation of medical and surgical face masks in relation to COVID-19

Two Melbourne-based companies and two Sydney-based companies have each been issued an infringement notice for $13,320 by the Therapeutic Goods Administration (TGA) for the alleged unlawful importation of surgical and medical face masks in relation to COVID-19.

A fifth company, based in Sydney, has been issued two infringement notices totalling $26,640, while a Melbourne woman was fined $2,664, also for unlawful importation of surgical and medical face masks.

All six parties allegedly breached a condition of the Therapeutic Goods (Medical Devices – Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 by importing medical face masks that were not – at the time of the importation – included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile (NMS).

The exemption facilitates the purchase of specified types of medical devices by the Federal Department of Health to ensure the NMS has enough personal protective equipment to assist in reducing the spread of COVID-19 between individuals and healthcare professionals.

The TGA pointed out that none of the parties that were fined are under a contract with the Federal Department of Health, nor another agency of the Commonwealth acting on behalf of the Federal Department of Health, for this purpose.

Under the Therapeutic Goods Act 1989, therapeutic goods must be entered in the ARTG before they can be lawfully imported in Australia, unless a specific exemption, approval or authority applies.

“Where therapeutic goods are covered by an exemption, the conditions of the exemption must be complied with,” said the TGA. “Failure to do so exposes a company or any relevant individual to criminal prosecution or civil penalty proceedings.”

Face masks meet the definition of a ‘medical device’ when the following claims are made:

  • The face mask is to be used for the prevention of the transmission of disease between people, or;
  • The face mask is suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services.

If the manufacturer’s labelling, advertising, or documentation contain the claims above, the face mask is considered to be a medical device and is required to be included in the ARTG.

This is regardless of whether other information, such as a customs slip, is subsequently added to the box stating the masks are ‘not for medical use’.

However face masks which are non-sterile and are not intended by their manufacturer to be used for the prevention of the transmission of disease between people are excluded from regulation by the TGA.

“There has been a significant increase in the domestic manufacture of reusable cloth masks and single-use face masks intended to be used by the general public when social distancing is not possible,” said the TGA.

“These types of face masks are not intended for use in a clinical setting or explicitly to prevent the transmission of disease between persons and therefore are not subject to the same regulations as surgical masks or some respirators.

“This type of reusable cloth mask or single-use mask can be manufactured and supplied without needing to be included in the ARTG,” said the regulatory body.

“However, these masks must not be advertised or labelled in a way that indicates the mask prevents the spread of disease between people, or for the use in healthcare (including aged care) settings. Instead, manufacturers could clearly indicate the mask is designed to be used by the public when social distancing is difficult or for general activity.”

During the COVID-19 pandemic, the TGA has issued a number of infringement notices in relation to the alleged unlawful importation of medical and surgical face masks, as well as a number of other items such as disinfectant, hand sanitiser and even “anti-virus activewear”.

“These breaches are of significant concern to the TGA given the current pandemic,” it said. “The TGA’s highest priority is to protect the health and safety of the Australian public through regulation of therapeutic goods.”

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