The TGA has issued an infringement notice for $2,664 to a Sydney-based pharmacist for the alleged unlawful importation of medical face masks in relation to COVID-19
The pharmacist 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 ARTG and were not being imported for supply to the National Medical Stockpile.
The TGA notes that the exemption is to facilitate the purchase of specified types of medical devices by Health to ensure the Stockpile has enough personal protective equipment to help reduce the spread of COVID-19 between individuals and health workers.
The pharmacist is not under a contract with the Australian Government Department of Health, or another agency of the Commonwealth acting on behalf of the Australian Government Department of Health, for this purpose, it notes.
The TGA highlights that under the Therapeutic Goods Act 1989, 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,” it says.
“Failure to do so exposes a company or any relevant individual to criminal prosecution or civil penalty proceedings.
“When manufacturers provide information to the TGA that the intended purpose of a mask is to prevent transmission of disease between people, this information confirms the mask is a medical device, regardless of whether other information, such as a customs slip, is subsequently added to the box stating the masks are ‘not for medical use’.”
The TGA says it is supporting suppliers of products that are not covered by the exemption to include them on the ARTG as a priority.
“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 current pandemic.”
Recent notices include those issued to two Melbourne-based companies and two Sydney-based companies, each of which was issued an infringement notice for $13,320 for the alleged unlawful importation of surgical and medical face masks in relation to COVID-19.