Changes

Departmental officers, importers and industry are advised that new standard import conditions for human diagnostic kits for testing Listed Human Diseases have been developed.

Who does this notice affect:

Importers of diagnostic test kits for Listed Human Diseases and Assessment Services Group.

Background:

Listed Human Diseases are human communicable diseases that may cause significant harm to human health, and are published on the Department of Health's website.

[https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-biosec-list-diseases.htm]

Two new permit cases for standard import conditions for diagnostic test kits for Listed Human Diseases have been created:

• Diagnostic test kits for testing Listed Human Diseases – kits included on the Australian Register of Therapeutic Goods
  

• Diagnostic test kits for testing Listed Human Diseases (this applies to kits that are not included on the Australian Register of Therapeutic Goods)
  

These new cases provide the standard import conditions that must be met to manage biosecurity risk associated with diagnostic test kits for Listed Human Diseases.

These new sets of conditions will streamline and increase efficiency in the application process, as a permit application for a standard commodity can be applied for goods that can meet these standard import conditions.

For goods that cannot meet these standard import conditions, a permit application for a non-standard commodity will be required for the goods.

Import permits:

Importers can now apply for standard import permits for diagnostic test kits for Listed Human Disease if the specified conditions can be met.

Note: Permit holders who already have a valid import permit for related goods do not need to apply for a new permit.

Further information:

Please contact the Laboratory and Human Tissues Program on 1800 900 090 or email imports@agriculture.gov.au.