Obtaining approved COVID-19 rapid antigen tests

It is important that you only use COVID-19 rapid antigen tests (RATs) that are approved for use in Australia by the Therapeutics Goods Administration (TGA).

Where to get RATs for personal use

RATs for personal use are available in Australia through various sources:

• Government testing sites
• concessional access program
• schools
• employers
• retail outlets (such as supermarkets and pharmacies)
• online.

Each RAT you purchase should include:

• the test device
• additional chemical reagents, swab and/or sample applicator, where applicable
• a copy of the instructions on how to use the tests
• information on how to access the online instructional video.

If you are purchasing a RAT from a retail outlet or online, you need to make sure they are approved by the TGA and being sold in their original packaging.

You can check by visiting the COVID-19 rapid antigen self-tests that are approved in Australia page for the most up-to-date information.

Tips for buying RATs online

• Purchase from an Australian online retailer, where possible.
• Check that the RATs are approved by the TGA for supply in Australia at COVID-19 rapid antigen self-tests that are approved in Australia.
• Review the advertisement carefully - does it include one of the following statements:
  • ALWAYS FOLLOW THE DIRECTIONS FOR USE
  • ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE
• Check if the RAT is included in the Australian Register of Therapeutic Goods.
• Avoid purchasing RATs from overseas websites - your order may be stopped at the Australian border if you import a quantity greater than what would be reasonable for personal use.

Issues you might encounter when purchasing RATs

Be aware of some potential issues when purchasing RATs, such as being sold:

• unapproved RATs
• repackaged or relabelled RATs
• point-of care RATs instead of self-tests
• parallel imports.

Unapproved RATs

An unapproved RAT is one that is not entered on the Australian Register of Therapeutic Goods (ARTG).

These products have not been assessed by the TGA, meaning they do not come with the same assurances of safety, effectiveness and quality as those that have met Australian regulatory requirements. Simply put, unapproved versions may not work as expected, or work at all.

Repackaged or relabelled RATs

You may come across RATs that have been relabelled or repackaged into single items from a larger pack and do not contain vital information which is included in the instructions for use.

RATs that are divided or repackaged will not work if:

• all components, including the correct instructions, are not provided
• the test kit has been damaged
• the test kit is exposed to excessive light or heat.

Repackaging or relabelling RATs without authorisation or agreement from the sponsor or manufacturer is against the law, and you should report this activity to the TGA.

Self-tests vs point-of-care tests

Some retail outlets or online stores may try to sell you a COVID-19 test kit which isn’t suitable for you to use at home. It is important that you only buy RATs which have been approved for self-testing.

RATs for personal use are generally individually packaged and have been assessed by the TGA as acceptable for use by untrained members of the public. Further information on the supply of self-tests is available at COVID-19 Rapid Antigen Self-tests (for home use).

Point-of-care RATs are not suitable for personal use and can only be legally supplied under specific conditions.

Parallel imports

Many RATs are available both in Australia and overseas. The packaging or labels intended for other countries may be different, depending upon the legal requirements and language of the country where the RATs are intended to be sold.

A parallel import occurs when a product approved for supply and use in a foreign country is imported with the intention of being sold in Australia, or is imported by someone that is not the Australian sponsor for the product.

While these products may be manufactured by the same company that manufactures RATs for the Australian market, they may not have been manufactured or labelled in the same way as the product registered in the ARTG. It is against the law to sell a product that is not included in the ARTG or imported by the Australian sponsor.

How to tell if a RAT is approved for supply in Australia

If any of the following apply to your product, it may be unapproved product or a parallel import:

• there are no Australian sponsor (authorised supplier) details on the package
• the packaging and instructions for use are not in English or it does not contain instructions for use at all
• the price you purchase it for is cheaper than a consumer would ordinarily expect to pay for the product in Australia
• it appears to have been repackaged or relabelled.

Importing RATs into Australia

Personal supply

Consumers can legally import a small quantity of rapid antigen self-tests into Australia for their own personal use or the use of their immediate family under the Personal importation scheme.

When imported under this scheme, the self-test can only be used by you or your immediate family members in your household and cannot be supplied (sold or given away) to any other person. Giving away or selling RATs imported under the scheme is against the law.

Commercial supply

If you are importing RATs for any purpose or volume other than personal use, including selling or giving away, refer to the importing COVID-19 rapid antigen tests commercial supply factsheet.

What are the consequences of importing unapproved RATs?

Loss of product

Under instruction of the TGA, the Australian Border Force can seize and destroy unlawful imports of therapeutic goods, including RATs.

Fines or court action

The TGA investigates unlawful import, supply and advertising of RATs in Australia and encourages compliance with Australian laws by providing education and guidance in the first instance. Failing to adhere to the Australian rules can attract significant penalties.

For repeated and deliberate non-compliance, the TGA takes escalated regulatory action which can include injunctions, civil court proceedings and criminal prosecution.

Where do I report suspected unapproved RATs?

If you have any concerns about a business supplying, advertising, or importing unapproved RATs, or about those being sold in retail outlets, you can:

• report a perceived breach or questionable practice
• make a report about non-compliant advertising

Further information

• COVID-19 rapid antigen self-tests (for home use)
• List of approved self-tests: COVID-19 rapid antigen self-tests that are approved in Australia
• List of all other approved RAT tests: COVID-19 test kits included in the ARTG for legal supply in Australia
• Buying parallel imports | ACCC
• Advertising enforcement and outcomes
• BICON - Import Conditions - Conditions (agriculture.gov.au)
• Media releases & statements

Examples - repackaged or relabelled products

Example 1

Repackaged into zip-lock bags. No instructions of use included.

Example 2

Repackaged into zip-lock bags. Instructions for use included.

Example 3

Repackaged and relabelled - not all components included - no instructions for use included.

Examples - comparison of Australian vs overseas products (parallel imports)

Example 1

Image of Australian approved version

Side view of Australian approved version showing Australian sponsor and address

Image of parallel import version

Side view of parallel import showing no Australian sponsor or address

Example 2

Parallel import version: No Australian distributor or Sponsor listed on the test kit.

Australian Sponsor, address, phone number and ARTG number on pack.

Example 3

Not displayed in English