The Therapeutic Goods Administration (TGA) has issued five infringement notices totalling $63,000 to Queensland company Promedical Equipment Pty Ltd. It is alleged that the company claimed or implied on its website and via social media that the TGA and the United States Food and Drug Administration (FDA) had endorsed or approved a COVID-19 Rapid Test kit.
Advertisements for therapeutic goods must not make any statement that implies the goods have been recommended or approved by government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators such as the FDA.
Promedical Equipment does not have a COVID-19 Rapid Test kit, or any other Class 3 in-vitro diagnostic medical device, included on the Australian Register of Therapeutic Goods (ARTG) for supply in Australia.
The TGA has informed Promedical Equipment that it must immediately remove all advertising it is responsible for in relation to COVID-19 Rapid Test kits from the Promedical website and social media platforms.
In light of the pandemic, COVID-19 advertising that is incorrect and misleading is of significant concern to the TGA. In March 2020, the TGA published a .
The TGA takes action against advertising breaches
The TGA investigates allegations of unlawful activity in relation to therapeutic goods, as the regulatory scheme is important to the safety of Australian consumers.
The TGA regulates all medicines, medical devices and biologicals used in Australia and implements a range of . Where appropriate this may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
Any person, including businesses, must comply with the . The TGA encourages online to deter possible severe outcomes.
