Alerts

Who does this notice affect:
Importers of diagnostic test kits and associated controls, calibrators, standards, and reagents, Assessment Services Group and Inspections Group.

Background:
A review of diagnostic kits has recently been completed. Changes will be made to the case design and import conditions, as well as the validity period of issued import permits. Changes will come into effect mid-August 2019, and are described below.

Case structure:

1. The updated BICON case will provide redirects to other BICON cases which may be more suitable, for example:
   

   • Personal consignments of diagnostic test kits for human therapeutic use.
     

   • Diagnostic test kits containing synthetic material only.
     

   • Diagnostic test kits containing highly refined organic chemicals and substances only.
     

   • Biological indicators containing microorganisms only.
     

2. The import pathways will be streamlined into the following import scenarios:
   

   • Nucleic Acid Amplification (e.g. PCR) diagnostic test kits.
     

   • Diagnostic test kits not testing for disease agents.
     

   • Diagnostic test kits testing for human conditions (excluding Listed Human Diseases and zoonotic diseases).
     

   • Plant diagnostic kits.
     

   • Other [All novel and non-standard permit applications can be submitted through this pathway].
     

Import conditions:

1. The current standard permit conditions for Molecular biology kits will be clarified. It will be updated to only facilitate the import of nucleic acid amplification (NAA) based kits; in most cases these will be PCR.
   

   To import other types of ‘molecular biology kits’ an alternative BICON pathway will need to be selected. There will no longer be any restrictions on the types of disease agents which can be tested for, all NAA kits may be imported (so long as the import conditions can be met). Please refer to the updated import conditions for molecular biology kits for further details of these changes.
   

2. The Listed Human Diseases have been updated to match existing legislation.
   

3. Additional reagents, controls, calibrators etc. may also be imported when specifically designed for use with diagnostic test kits eligible for import.
   

4. Diagnostic test kits are no longer required to be labelled for in-vitro use only. Please note that other Australian government departments or agencies may continue to require this.
   

5. There is no longer any differentiation between end use within and outside a laboratory on any standard permits.
   

Permits and applications:

1. A new questionnaire will be embedded into the BICON pathway “Other” (i.e. non-standard permit applications). This questionnaire will guide manufacturers/importers through the information that will be required in order to assess applications. Sample answers are contained. Please note that delays in assessment (and subsequent requests for advice) will occur if this information is not provided.
   

2. The validity period of import permits for diagnostic test kits will be extended to four years, as opposed to two. Import permits which include other goods will only be valid for the standard two year period.
   

Further information:
Contact the Business and Reform team on 1800 900 090 (prompt 1, then prompt 1 and ask for the ABIB Import Conditions Review section) or email at ABIBBusinessandReform@agriculture.gov.au.