• Section 1 - Summary
• Section 2 - Scope
• Section 3 - Policy/Regulation
• Section 4 - Procedures
• Part A - Summary of Roles and Responsibilities
• Part B - Permits and Licensing Requirements
• Part C - Authorised Use of the University Biological Import Permit
• How to Apply for Authorised Use of University Biological Import Permit
• Part D - Approval of New Biological Import Permits
• Part E - BICON Permit Conditions for Importation of Biological Material
• Part F - Export of Biological Materials
• Part G - Legislative Requirements
• Section 5 - HESF/ASQA/ESOS Alignment
• Section 6 - Definitions

Section 1 - Summary

(1) This Procedure:

1. outlines Victoria University’s (VU) processes for importing biological material (including live animals) into Victoria and Australia. It is intended to provide guidelines to promote biosafety and prevent unintended spread of microorganisms, pest animals and plants;
2. outlines VU processes for exporting biological material out of Australia;
3. ensures compliance with biosafety legislation, regulations and standards that VU must follow.

(2) Australia has strict biosecurity measures for the import and export of biological material. The Australian Government publishes information about import conditions and permits through the biosecurity import conditions database (BICON).  BICON lists the import conditions for thousands of commodities. 

Section 2 - Scope

(3) This Procedure applies to all VU staff that need to import or export biological material, and Technical Services personnel that maintain facilities where biological material is used and stored.

Section 3 - Policy/Regulation

(4) Biosafety Policy

Section 4 - Procedures

Part A - Summary of Roles and Responsibilities

Part B - Permits and Licensing Requirements

(5) VU Staff must use the University’s BICON-issued standard Import Permit to import controlled biological material as outlined in this Procedure.

(6) VU Staff must not import:

1. goods from countries listed as sanctioned. 
2. goods prohibited by Customs (which includes those listed on the Defence and Strategic Goods List 2024 (Cth) (DSGL)), as additional restrictions and licensing apply. Contact the Senior Manager, Research Infrastructure & Biosafety for further information.
3. goods classified as Security Sensitive Biological Agents (SSBA) as additional licensing is required. Contact the Senior Manager, Research Infrastructure & Biosafety for further information.
4. plants and animals classified as prohibited, controlled, or regulated pests, as additional restrictions and licensing apply. Contact the Senior Manager, Research Infrastructure & Biosafety for further information.

Part C - Authorised Use of the University Biological Import Permit

(7) The Senior Manager, Research Infrastructure & Biosafety is the only person authorised to apply for biological import permits at VU and will maintain a register of authorised biological import permits.

(8) Biological import permits are administered by the Technical Manager responsible for the facilities where the goods will be used.

(9) Biological import permits must not be obtained by the end-user.

(10) End-users will confirm whether they require an import permit by determining the commodity classification of their goods using the Biosecurity Import Conditions on the BICON website. If uncertain about the classification of goods, the End-user must contact the Senior Manager, Research Infrastructure & Biosafety.

(11) The VU Import Conditions by Commodity should be consulted before requesting to import any biological materials.  For items that are not listed, please consult the Senior Manager, Research Infrastructure & Biosafety.

How to Apply for Authorised Use of University Biological Import Permit

(12) End-Users should first consult the How to Import Biological Material Flowchart.

(13) To request the use of a permit, the end-user must complete the online Request to Import Biological Material Form.  This form must be completed by end-users that intend to receive ANY biological material via import from overseas. This includes biological material that will be received through the mail, via international couriers, or customs agents.

(14) The form should be accompanied by the Suppliers Declaration Letter template.

(15) It is the end-users responsibility to confirm the classification of their commodity and sign the declaration agreeing to abide by the conditions of the permit. 

(16) The completed form must be submitted by email to ibc@vu.edu.au.  The Senior Manager, Research Infrastructure & Biosafety (or delegate) will review the application and approve the material for import if deemed acceptable. 

(17) Following approval, the VU import permit will be issued to the VU Technical Manager responsible for the facilities where the goods will be stored and used. 

Part D - Approval of New Biological Import Permits

(18) Importation of biological material not listed on the VU Standard Import permit may require a new import permit.

(19) If a new permit is required, the end-user should complete the Request to Import Biological Material Form.

(20) The Senior Manager, Research Infrastructure & Biosafety (or delegate) will apply for the permit through BICON on behalf of the University and the end-user.

(21) Once BICON approves the permit, the Senior Manager, Research Infrastructure & Biosafety (or delegate) will authorise the relevant VU Technical Manager to administer the permit, as required, to the end-user.

(22) Depending on the goods, it can take BICON up to 20 working days (or longer) to assess a permit.

(23) Fees may be charged to an account specified by the end-user if the goods are determined as project-specific.

Part E - BICON Permit Conditions for Importation of Biological Material

(24) The BICON conditions under which the permit is granted are written on the permit. These include but are not limited to:

1. Administrative conditions
   1. Quarantine entry document, invoice, waybill or importers manifest may be required.
2. Entry conditions
   1. Restriction to quantities and/or sizes of containers may apply.
   2. Forced irradiation of goods may apply.
   3. Restrictions on countries of origin may apply.
3. Packaging and Labelling Conditions
   1. Goods must be packaged to comply with all the relevant governing bodies. For a list of governing bodies, see the Biosafety & Biocontainment SharePoint site.
   2. To ensure compliance with packaging requirements the end-user must also consult the Biosafety - Packaging and Transport of Biological Materials Procedure and Biosafety - Labelling, Storage and Transport of Genetically Modified Material Procedure which detail additional regulatory requirements for the movement of biological materials.
4. Post entry/end-use conditions
   1. Restriction to use in vitro, in vivo in laboratory animals and/or in vivo in humans may apply.
   2. Restriction to laboratory certification requirements may apply.
   3. Restrictions to the transfer of goods to third parties may apply.

(25) The end-user must ensure the entry; packaging and post-entry conditions on the permit are met at all times. Fees may be charged to an account specified by the end-user if the goods are assessed as project-specific.

(26) Once received, the end-user must refer to the following procedures, as required: Biosafety - Packaging and Transport of Biological Materials Procedure, Biosafety - Labelling, Storage and Transport of Genetically Modified Material Procedure, Biosafety - Dealings Involving Risk Group Agents Procedure and Biosafety - Dealings Involving Genetically Modified Organisms Procedure.

Part F - Export of Biological Materials

(27) An OHS Risk Assessment must be completed for export goods and sent to the relevant Technical Manager for review, prior to commencing export processes.

(28) Where applicable, project-specific approval(s) must have been granted (i.e. IBC, AEC and/or HREC). The need for a Material Transfer Agreement (MTA) should also be determined.

(29) Determine if there is a need to obtain a permit to export goods.  Consult the Department of Agriculture, Fisheries and Forestry (DAFF) and Therapeutic Goods Authority for further information.

(30) Check the country of destination’s specific importing requirements.

(31) Goods must not be exported to countries on the sanctioned countries list. 

(32) Goods must be packaged as outlined in the Biosafety - Packaging and Transport of Biological Materials Procedure.

Part G - Legislative Requirements

(33) Any personnel importing or exporting biological material must understand and adhere to this procedure.

(34) If authorised material is brought into Australia without the relevant import permit, the material will be confiscated and destroyed by Biosecurity and Custom’s officials and the end-user liable for potential prosecution.

(35) The Biosecurity Act 2015 states that conditionally non-prohibited goods must not be brought or imported into Australian territory unless the specified conditions (including conditions for administrative purposes) are complied with.

(36) It is a criminal offence, pursuant to section 186 of the Act, to bring or import goods into Australian territory without an import permit, where one is required.

(37) The Act does not provide for permits to be issued after the goods have been brought into Australian territory.

Section 5 - HESF/ASQA/ESOS Alignment

(38) HESF: Standards 2.3 Wellbeing and Safety; 4.1 Research; 4.2 Research Training; 5.2 Academic and Research Integrity.

Section 6 - Definitions

(39) BICON – BICON is the Department of Agriculture, Fisheries and Forestry’s biosecurity import conditions system. Allows clients to obtain import conditions for specific commodities without having to contact the department.

(40) Certificate of origin – A certificate of origin states the country of origin of the goods. The seller, manufacturer or a chamber of commerce in the country of origin may issue certificates of origin.

(41) Defence and Strategic Goods List 2024 (Cth) – The DSGL is a legislative instrument for the purposes of the Legislation Act 2003. The purpose of the DSGL is to list goods and technologies subject to export control and provides guidance to multiple agencies. The DSGL underpins Australia’s export controls and is required to ensure that Australia remains compliant with its international obligations.

(42) End-user – The VU staff or student(s) intending to use and store imported biological material in University facilities.

(43) Export – A consignment is considered to be exported when it is lodged with the freight forwarder, shipping company/airline, charter operator or an appointed agent in the country of origin.  For sea transport for ultimate destination in Australia, it is considered exported when:

1. it is shipped on board the vessel
2. it is packed in a container and sealed in preparation for export.

(44) Freight forwarder – A person or corporation who arranges transport of goods on behalf of either the seller or buyer. A freight forwarder will often consolidate several small shipments into one larger shipment to take advantage of better freight rates. In most cases, the freight forwarder will assume the legal liabilities of acting as a carrier.

(45) Importer – For the purposes of this procedure, the importer is the person or company importing the goods.

(46) Material Transfer Agreement (MTA) – An MTA is a contract that governs the transfer of tangible research materials between two organisations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives.

(47) Security Sensitive Biological Agents (SSBA) and Standards – The SSBA Standards are determined under section 35 of the National Health Security Regulations 2018. They set out the requirements that must be met by the entity to ensure physical security around handling, storage, disposal, and transport of SSBAs and biological agents suspected of being SSBAs, as well as personnel and information security.

(48) Waybill – A document prepared by the carrier of a shipment of goods that contains details of the shipment, route and charges.