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TGA Information

RapidProof.com.au is a distributor Rapid Antigen Tests Assessed & Listed on the Australian Register for Therapeutic Goods (ARTG).

 

The TGA has approved a number of COVID-19 rapid antigen tests for supply in Australia.

On 1 October 2021 a new legal instrument (link is external) was made to allow suppliers to apply for regulatory approval to supply self-tests for use at home in Australia after 1 November 2021. 

COVID-19 rapid antigen self-tests (home use tests) can only be supplied to consumers for self-testing and included in the Australian Register for Therapeutic Goods (ARTG) for that purpose. 

Further information on the supply of self-tests is available at COVID-19 Rapid Antigen Self-tests.

Suppliers of COVID-19 rapid antigen tests and testing service providers must make sure that any publicly accessible advertising of rapid antigen tests is compliant with the Therapeutic Goods Advertising Code (link is external) and the conditions of supply and use as they appear on the Australian Register of Therapeutic Goods.

The Advertising Code specifies the requirements for advertisements of health products. For example, it requires advertisements to be balanced, accurate, substantiated and not misleading. Under the Advertising Code, advertisements:

  • Must be consistent with the directions/instructions for use of the advertised product
  • Must not exaggerate the efficacy or performance of the product or encourage inappropriate use
  • Must not be likely to lead people to delay necessary medical attention (such as immediately presenting for a diagnostic PCR test to confirm whether or not they have COVID-19), and
  • Must not be inconsistent with public health campaigns.

The Advertising Code also includes specific requirements for an advertisement for a therapeutic good (including rapid antigen tests).

It is also important that any advertisement is consistent with government health messaging in relation to testing for infection with COVID-19.

We do our best to ensure we are compliant at all times.