The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice for $13,320 to the Victorian company Bulk Buys Pty Ltd (Bulk Buys). It is alleged the company breached the Therapeutic Goods Act 1989 (the Act) in relation to the importation of surgical face masks.
Bulk Buys allegedly breached a condition of the Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (the exemption) by importing surgical 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.
Under the Act, therapeutic goods must be entered in the ARTG before they can be lawfully imported into 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. Failure to do so exposes a company or any relevant individual to criminal prosecution or civil penalty proceedings.
The TGA has issued a number of infringement notices in relation to the alleged unlawful importation of medical and surgical face masks. These breaches are of significant concern to the TGA given the pandemic.
The TGA's highest priority is to protect the health and safety of the Australian public through regulation of therapeutic goods.
How to determine if face masks are therapeutic goods
The TGA has published guidance on face masks and respirators that are regulated by the TGA. This guidance helps consumers, health professionals, and government officials to determine when a face mask is a medical device and therefore must be included in the ARTG.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.
