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Warning to consumers and advertisers about COVID-19 test kits
Update on 1 October 2020: Advertisements for test kits for COVID-19 infections cannot be directed to consumers. This includes self-tests for COVID-19, for which supply is prohibited under the Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020.
Warning to consumers about self-test kits
The Therapeutic Goods Administration (TGA) warns consumers to be cautious when seeking to purchase products claiming to be home self-tests for COVID-19, either online or through other means.
In Australia, the advertising and supply of self-tests for serious infectious diseases, such as COVID-19, is prohibited under therapeutic goods legislation. COVID-19 tests are designed to be used under the direction of a health professional. Home tests may give a false positive or false negative result, which could be extremely dangerous for yourself and others if relied on.
Testing for COVID-19 should only be conducted in an accredited pathology laboratory, or by a healthcare professional at the point of care. This is so immediate clinical advice and treatment can be provided to the individual, and further information regarding possible limitations of the test, including the risk of false positive and false negative results, can be taken into consideration.
Warning to advertisers about test kits
In response to the COVID-19 pandemic, the TGA has taken measures to ensure Australia has laboratory and point of care tests available that are able to detect COVID-19 infections. These measures are designed to facilitate the legal importation, manufacture and supply of these tests. The measures do not exempt these test kits from the operation of the TGA advertising framework.
We remind advertisers of their obligations under therapeutic goods legislation. Specifically, compliance with the advertising framework including the Therapeutic Goods Advertising Code (No.2) 2018 means that:
- an advertisement for COVID-19 test kits when directed exclusively to health professionals is exempt from the legal requirements for advertising therapeutic goods to consumers. Appropriate measures must be in place to ensure the advertisement is only accessible by health professionals (e.g. use of firewalls, or a requirement to register to gain access to online advertising). If the online advertising can be viewed by the public, the exemption will not apply.
- advertisements for test kits for COVID-19 infections cannot be directed to consumers. In Australia, the supply of self-tests for most serious infectious diseases, including self-tests for COVID-19, is prohibited under the Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020.
The TGA refers advertisers to its recent warning in relation to illegal advertising of therapeutic goods. The TGA will take action in relation to any advertisements that do not meet the requirements, including those that seek to mislead consumers. Penalties apply.