Changes

The Department of Agriculture, Fisheries and Forestry has made changes to the standard permit conditions for test kits testing for the Listed Human Diseases, that are included on the Australian Register of Therapeutic Goods (ARTG) to reduce the documentation requirements for importers and expand what may be imported under the permit.

Importers will now only be required to supply consignment-specific evidence that any imported test kits used for in vitro diagnostic testing for the Listed Human Diseases are included on the ARTG. This must include the ARTG identifier number (ID) and product name/s.

Please note that import conditions still apply. Importers are urged to read and confirm that they can meet all import conditions before applying for the standard permit.

The change to import conditions will not apply to import permits that have already been issued and holders of these import permits will be required to supply documentation as stipulated in their import permit conditions.

Who does this notice affect:
Applicants, brokers and importers of laboratory goods, biosecurity staff and Pathway Operations Cargo – Assessment and Inspections.

Further information:
Please contact the Laboratory and Human Tissues Program on 1800 900 090 (option 1, option 1) or email imports@agriculture.gov.au (please title the subject line of the email with ‘Biologicals T2 – Test kits').