The Therapeutic Goods Administration (TGA) has issued Oxymed Australia Pty Ltd five infringement notices, with penalties of $63,000 for alleged advertising breaches.
The alleged contraventions relate to the advertising of hyperbaric oxygen therapy chambers, not included in the . Unless a specific exemption applies, therapeutic goods must be entered in the ARTG before they can be lawfully supplied or advertised in Australia.
The advertisements for hyperbaric oxygen therapy chambers made therapeutic claims to treat serious ailments, diseases and conditions. These included representations in relation to Coronavirus (COVID-19). Such references amount to under therapeutic goods legislation, and are of significant concern to the TGA given the current pandemic. The TGA recently published .
Any person, including businesses, must comply with the . The TGA encourages online to prevent potentially serious consequences.
The TGA regulates all medicines, medical devices and biologicals under the (the Act). The regulatory scheme is important to the safety of Australian consumers and the TGA investigates suspected illegal activity related to therapeutic goods.
