top of page

Importation of COVID-19 Rapid Antigen Test (RAT) kits

This article was originally published via https://www.agriculture.gov.au.


Frequently Asked Questions



Where can I find information about import conditions for RAT kits?


Information about biosecurity import conditions can be found on BICON - Australian Biosecurity Import Conditions. We recommend that importers search for “test kit” and follow the path that best describes their product and how it will be used (further information is provided below).

More information about the requirements for import and supply of COVID-19 RAT kits in Australia can be found on the Therapeutic Goods Administration (TGA) website.


Do RAT kits require a permit?


RAT kits do not require an import permit if:

  1. They are lateral flow test kits approved by the TGA for supply in Australia and meet all of the import conditions published on BICON; or

  2. They are for personal use (i.e. for use by the individual importing them or their immediate family). See below for more details about personal use.

For all other types of COVID-19 test kits and uses, a biosecurity import permit is required.


Can I import RAT kits for personal use without a permit?


You can import RAT kits for personal use without a permit if they meet the ‘COVID-19 rapid antigen test (RAT) kits for personal use’ conditions in BICON.

By 'personal use' the department means: a three-month supply for use by the person importing the goods; or for use by any spouse, de facto partner, child, parent or sibling of the person importing the goods.

Note personal consignments of COVID-19 RAT kits that are not approved for supply in Australia by the TGA (i.e., listed on the ARTG) may be referred to the TGA for assessment upon arrival in Australia.


What are Australian Register of Therapeutic Goods (ARTG) listed RAT kits?


Information about ARTG listed COVID-19 RAT kits is available on the Therapeutic Goods Administration website.

If you are importing ARTG listed RAT kits, search for ‘test kits’ in BICON, and review the conditions listed under ‘Lateral flow test kits on the ARTG – including COVID-19 RAT kits’. If your goods meet the listed conditions, you do not require an import permit.

Note: You will still need to supply documents with your goods to verify that import conditions have been met. For more information on documentation requirements for RAT kits please see below.


Will test kits imported for personal use be assessed by biosecurity officers and customs on arrival in Australia?


COVID-19 rapid antigen test (RAT) kits imported for personal use will be subject to assessment by Department of Agriculture, Fisheries and Forestry biosecurity officers and Australian Border Force customs officers.

These agencies will assess goods imported for personal use against different risks:

  • Biosecurity officers will assess imported COVID-19 RAT kits from a biosecurity risk management perspective.

  • Customs officers – working with the Therapeutic Goods Administration (TGA) – will assess the safety and efficacy of the goods, particularly those that have not yet been approved for use in Australia by the TGA.


If importers bring in COVID-19 RAT kits for non-personal uses (e.g. for commercial sale or for use by employees or volunteers of a business or non-government organisation etc) they must either have a biosecurity import permit or meet the conditions for “Lateral flow test kits listed on the Australian Register of Therapeutic Goods” on BICON. If these conditions cannot be met, the consignment will be exported or destroyed at the importer’s expense.


What if I need to import RAT kits for TGA approval or research purposes?


If you are importing RAT kits for TGA approval or research purposes, you will require a biosecurity import permit. Please search for ‘test kits’ in BICON, and check the box for ‘test kits testing for Listed Human Diseases’, and follow the pathway to review the conditions for ‘Test kits testing for Listed Human Diseases – not included on Australian Register of Therapeutic Goods’.

These conditions do not allow the kits to be distributed or for home use.


How do I find a RAT kit ARTG reference number?


All TGA approved RAT kits can be found on the Australian Register of Therapeutic Goods.


What are the requirements of a manufacturer’s declaration?


A manufacturer’s declaration must include the statements listed in the relevant import conditions page (on BICON or on your permit). For example, there are specific statements required on a manufacturer’s declaration when you are importing ‘Lateral flow test kits on the ARTG’. A manufacturers declaration must also meet the following requirements:

  1. The document must have been issued and dated within the last six months, unless otherwise stated.

  2. The document must be on the manufacturing company's letterhead and include their name and address.

  3. Declarations must include the employee's name and their title within the company of the person issuing the document.

  4. The document must contain the correct statement(s) as required by the import conditions.

  5. The document must be specific to the good(s) and consignment unless otherwise stated in BICON, an import permit.

  6. Declarations will only be accepted from the company that manufactured/produced the goods (either the specific site or head office within the country of export) unless stated otherwise.


Further information on the requirements for a manufacturers declaration can be viewed in BICON, or in the department’s Minimum documentary and import declaration requirements policy.


Can I import RAT kits from any country?


As long as your RAT kits meet the conditions listed in BICON or on your permit, you can import from any country.


How do I find COVID-19 RAT kits on BICON?

1. Search ‘Test kits’ in the Quick search bar.



2. Select the ‘Test Kits’ case from the search results.



3. For non-personal uses (e.g. for commercial sale or testing of employees), select the ‘Lateral flow test kits on the ARTG – including COVID-19 RAT kits” pathway to review import conditions for these goods.


4. For personal uses (e.g. use by the person importing the goods or by any spouse, de facto partner, child, parent or sibling of the person importing the goods), select the ‘COVID-19 rapid antigen test (RAT) kits for personal use’ pathway.



I’m new to importing test kits into Australia, where can I find more help?


New importers may wish to consider using the services of a customs broker or freight forwarder who is familiar with the import process for your type of goods.

More information about customs brokers and freight forwarders can be found on webpages managed by the Australian Border Force and the Australian Trade and Investment Commission.

General information about importing goods into Australia has also been published by the Australian Food and Beverages Association which may be of use to first time or infrequent importers.


Do importers need to declare test kits to customs on arrival in Australia?


You may need to complete a customs import declaration for consignments of COVID-19 rapid antigen test (RAT) kits imported into Australia.

For more information, please review the Australian Border Force’s ‘How to Import’ webpage.


Why is the Australian Government allowing people to import up to a three months’ supply of COVID-19 rapid antigen test kits for personal use?


Australians with appropriate documentation have long been able to import up to a three-month supply of human therapeutics and medicines without an import permit – including test kits – for their own personal use. The TGA also have provisions for the import of human therapeutics for personal use.

Due to the high public interest in COVID-19 rapid antigen test (RAT) kits, the department published a more specific import pathway in January 2022 to help clarify that the import conditions for personal use human therapeutics also apply to COVID-19 RAT kits.

As with other human therapeutics and medicines imported for personal use, importers of COVID-19 RAT kits must present evidence that the goods are for personal use and in a quantity of no more than three months’ supply.


6 views0 comments

Comments


bottom of page