Changes

Departmental officers, importers and industry are advised that the standard import conditions for diagnostic test kits have been updated for the following cases:

• Nucleic acid amplification diagnostic test kits,
• Diagnostic test kits not testing for disease agents, and
• Diagnostic test kits testing for Listed Human Diseases (kits not on the Australian Register of Therapeutic Goods).

Who does this notice affect:
Importers of test kits and Assessment Services Group.

Background:
The import conditions for diagnostic test kits testing for Listed Human Diseases (for kits that are not included on the Australian Register of Therapeutic Goods) have been updated to remove reference to the term ‘diagnostic’. This change will broaden the scope of kits permitted to be imported under this case (e.g. test kits for research purposes etc.).

In the last few months, similar updates were made to the following two cases:

• Nucleic acid amplification (e.g. PCR) diagnostic test kits.
• Diagnostic test kits not testing for disease agents.

Goods that are permitted under these import conditions are no longer restricted to kits for ‘diagnostic’ use only.

Import Permits:
Importers can now apply for import permits if the specified conditions can be met for:

• nucleic acid amplification test kits
• test kits not testing for disease agents
• test kits testing for Listed Human Disease.

Please note: Permit holders who already have a valid import permit for these goods do not need to apply for a new permit if existing permit conditions meet their needs to import their goods. If a permit holder wishes to use these new conditions, an application to either vary an existing permit or for a new permit can be submitted via BICON. Note that variation to an existing permit does not extend permit validity period and will result in a new permit number being issued.

Further information:
Please contact the department on 1800 900 090 (prompt 1, prompt 1) or via email at imports@agriculture.gov.au .