Buying and selling COVID-19 rapid antigen test kits

If your business buys rapid antigen test kits to use in your business operations or to sell, there are laws you need to be aware of and steps to consider to maintain your supply.

Maintaining your supply

Due to COVID-19, Australian businesses may have trouble getting rapid antigen test kit supplies, so it's important to start thinking about your supply chain and what would happen if this was blocked.

To maintain your supply of rapid antigen test kits throughout 2022, you should consider taking the following steps:

When you import rapid antigen tests

If you would like to import rapid antigen tests to use in your business operations or to sell in Australia, you'll need to ensure you are purchasing an approved product on the Australia Register of Therapeutic Goods (ARTG).

Any rapid antigen tests that are imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import. The tests must be on the ARTG, under the name of the supplier, prior to importation.

Failing to adhere to the Australian rules can result in penalties.

Reporting a problem with testing kits your business buys

Problems or issues with a test can be reported back to the place where you purchased the test or to the supplier of the test through the customer support contact information provided in the instructions provided with the test.

You can also report the problem directly to the Therapeutic Goods Administration (TGA) through their online form.

Your supplier is required to report serious adverse events related to the use or performance of the device, and all complaints associated with false positive and false negative results to the TGA.

Advertising the rapid antigen test kits you are selling

When you advertise the rapid antigen test kits your business sells, you must comply with the Therapeutic Goods Advertising Code.

Legally, your business cannot say or imply the advertised goods are approved or endorsed by the TGA or any other government authority.

Representations used in advertising that refer to COVID-19 must be approved or authorised by the TGA. The TGA has authorised legally-binding requirements for what advertisements for COVID-19 rapid antigen self-tests can and cannot say.

Price-gouging

Businesses are free to set the prices of their products or services. Neither the ACCC or your local state or territory agency have roles in setting prices.

But the Australian Consumer Law does protect consumers from unconscionable conduct by businesses. This means you shouldn't exploit customers, especially if your product or service is critical to health or safety, such as rapid antigen testing kits.

Whilst there isn't a precise legal definition for unconscionable conduct, you should always ensure that your conduct isn't so harsh that it goes against good conscience.

Including GST

If you are selling rapid antigen COVID-19 test kits, you need to include GST in the price of these kits. This is because rapid antigen COVID-19 test kits are not a ‘medical aid or appliance’ that is listed in either Schedule 3 to the GST Act or the GST Regulations, so they’re not GST-free.