Importing or Exporting Biological Materials

Importing Biological Materials

Biological goods or materials are goods that contain or are made using any material originating from an animal, plant or microbial (including viral) source. The importation of some biological materials is, by law, subject to biosecurity import conditions. Some products are not permitted entry while other products are only allowed into Australia subject to meeting import conditions that mitigate the biosecurity risk. This may include a requirement for a biosecurity import permit.

The Department of Agriculture, Fisheries and Forestry (DAFF; the Department) regulates products imported into Australia, and prosecutes any breaches under the Biosecurity Act 2015. You can use the Biosecurity Import Conditions System (BICON) to determine whether the import of specific goods into Australia:

  • is permitted
  • is subject to import conditions
  • requires supporting documentation
  • requires treatment
  • needs an import permit

Applying for an import permit

To apply for an import permit, raise an enquiry via ibc@une.edu.au, including details on what you need to import and what the use of the material will be. If a suitable import permit has previously been issued to UNE and is still active, this may be able to be used. Otherwise, the Research Governance and Compliance Officer (our UNE BICON administrator) will work with you to prepare and submit an application for an important permit in BICON. Application fees are outlined on the Departments website and must be covered by the researcher.

Permit applications can take anywhere from 4-14 weeks to be processed, so plan well in advance to allow sufficient time for the application to be assessed before the material is required. Biosecurity material imported without an import permit will be destroyed at the Australian border or sent back to the country of origin. Permits cannot be applied for retrospectively.

There are some specific restrictions on the import of biological materials which should be considered early in the application process. For example, import permit conditions may include restrictions on how the imported materials may be used (e.g., for in vitro use only) or the species that may be exposed to the imported materials (e.g., approved for use in laboratory species such as guinea pigs, hamsters, mice, rats, rabbits or microorganisms only). Your specific requirements for using important materials must be considered so that any Import Permit conditions do not hinder your ability to conduct the required work.

Note: If in vivo use of an important product hasn't been included in your original import permit conditions, but you need to use the product in vivo as part of your study, you willneed to apply to the Department for a separate application for In Vivo Approval (IVA).

Storing and working with imported materials

Some import permits require the imported material to remain in an Approved Arrangement (AA). Previously called Quarantine Approved Premises, AAs are understood as contracts between the organisation and the Department that allow the organisation to manage the biosecurity risks that arise from the materials at their specific premises, facilities, equipment and people.  Each import permit indicates whether materials need to be stored and handled under an Approved Arrangement (AA). You should check this thoroughly and make enquiries about whether this will be the case early in the import application process, as UNE currently has no Approved Arrangements.

Getting premises accredited as Approved Arrangements is a very lengthy process, so do consider carefully if your research involves work with imported biologicals, and notify the IBC as soon as possible, so that they can determine if your work can be conducted within a facility at UNE.

However, work with imported biological materials may still be possible at UNE, as in some cases, a PC1 or PC2 lab may be sufficient (as stipulated on the import permit).

Note: Approved Arrangements and Physical Containment (PC) facilities are not interchangeable, so PC facilities may only be used for working with imported materials if the Department stipulates that:

  • the material has been released from quarantine; or
  • that the material is released to a PC1 or PC2 facility.

Exporting Biological Materials

The Australian Government regulates the export of certain controlled goods, and an export licence is required for many materials. The export of some products is regulated by the Therapeutic Goods Administration, and the export of GMOs and GMO products are regulated by the Office of the Gene Technology Regulator. For specific advice on exporting biological materials or products from UNE, raise an enquiry via ibc@une.edu.au.