Changes

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 test kits has recently been completed. Changes have been made to the case design and import conditions, as well as the validity period of issued import permits. Changes are described below.

Case structure:

1. The updated BICON case provides 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 test kits testing for plant pathogens. Please note that a separate BICON case has now been created for these goods.
     

2. The import pathways have been 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).
     

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

Import conditions:

1. The existing standard permit conditions for Molecular biology kits have been 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.
   

2. There are no longer any restrictions on the types of disease agents which NAA kits can test for. For further details on this change please review the updated import conditions.
   

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

4. Additional reagents, controls, calibrators etc. may also be imported when specifically designed for use with diagnostic test kits eligible for import. These reagents, controls, calibrators etc. must also meet the import conditions.
   

5. 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.
   

6. 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 has been 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 has been extended to four years, as opposed to two. Import permits which include other goods will remain 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.