A SYDNEY-BASED pharmacist has been issued an infringement notice for $2,664 relating to the alleged unlawful importation of medical face masks in relation to COVID-19.
The Therapeutic Goods Administration (TGA) said 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 importation, included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile.
"The exemption facilitates the purchase of specified types of medical devices by the Australian Government Department of Health to ensure the National Medical Stockpile has enough personal protective equipment (PPE) to assist in reducing the spread of COVID-19 between individuals and healthcare professionals," the TGA said.
"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.
"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. Failure to do so exposes a company or any relevant individual to criminal prosecution or civil penalty proceedings."
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