Export of Biologicals

Sending goods to a local facility, interstate or internationally, incurs different risks, packaging requirements and documentation. Professional judgement is paramount when assessing the risks and engaging with procedures to contain and manage them.

Guideline

 

Recommended Guideline

The Australia Post's International Post Guidelines provides excellent and comprehensive information on classification of dangerous goods, packing, country specific restrictions and required documentation.  

The guidelines on these UniSA webpages are not comprehensive and are merely intended to highlight export requirements and examples for biological material and organisms at UniSA. 

 

  1. If exporting interstate, check with Australian Interstate Quarantine for any specific state border restrictions.
  2. If exporting outside of Australia, check the export conditions including quarantine, dangerous goods classification and packaging, Defence Export Controls and import permit requirements of the recipient country. 
  3. If exporting outside of Australia, obtain a copy of the Import Permit issued to the recipient from their quarantine, or other appropriate authority, of their country. This Import Permit will need to be attached to the outer packaging.
  4. Check whether a Material Transfer Agreement (MTA) is required before arranging for export of goods. This is important to protect such things as ownership of goods, Intellectual Property, licensing and any costs associated with the transport of goods. To develop a MTA contact your local Academic Unit business development team or the Research Contracts team at Research and Innovation Service, research.contracts@unisa.edu.au.
  5. Check that the recipient is certified to contain and manage the biological. Ask the recipient for their Office of Gene Technology Regulator (OGTR), or equivalent, facility certification number, facility containment level and Approved Arrangements number (as applicable). This information is required for an Institutional Biosafety Committee (IBC) application, or amendment application, to export the biological. Likewise, the Animal Ethics Committee and Human Research Ethics Committee may require confirmation that the recipient has approvals to work with animals or human research samples. 
  6. Goods transported interstate will most likely involve air transport. Both interstate and international goods must be packed according to International Aviation Transport Association and Civil Aviation Safety Authority regulations. The Classify and Pack Biological Material webpage offers some guidance. The other good source of information is Australia Post's International Post Guidelines.
  7. Procedures must be in place to ensure that all GMOs or infectious samples, or the number of primary containers of cultures transported, can be accounted for and that a loss of GMOs or infectious samples during transport, or the failure of delivery, can be detected.
  8. Record the exportation.
  9. Prepare all documentation to be attached to the packaging, such as:
    • List of contents
    • Air waybill (which may be provided by the courier)
    • 3 copies of the Customs Declaration
    • Import Permit of destination country
    • Spills instructions (for infectious substances)
    • Name and contact details of both shipper and recipient

 

 

Export of therapeutic goods

To export therapeutic goods from Australia for commercial purposes, you must meet certain regulatory requirements set out in the Australian therapeutic goods legislation. The goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are exempt from being entered in the ARTG.

 

Every ARTG entry belongs to a 'sponsor' who is responsible for applying for and maintaining the ARTG entry. If you are planning to export a therapeutic good for commercial supply overseas, you must be the sponsor named in the ARTG entry for that good, or an authorised agent acting on behalf of the sponsor.

Export of human substances

The Therapeutic Goods Association (TGA) issues permits for exporting human substances, under the Customs (Prohibited Exports) Regulations 1958 (Regulation 8).

Export of human substances: Guidance about exporting human substances and how to apply for a TGA export permit.

Application for a permit to export human substances: Use this form to apply for a permit to export human substances.

Human Research Ethic Committee approval may be required for the export of human substances.

Unapproved therapeutic goods

There are certain circumstances where unapproved therapeutic goods that are not in the ARTG can be legally exported.

Import/export of unapproved therapeutic goods for experimental purposes: Guidance and application form for exporting unapproved therapeutic goods for clinical trials

Named Patient Program: Allows for the export of unapproved therapeutic goods for named patients overseas. For further information, contact the Experimental Products Section. eps@health.gov.au

DNA

Purified DNA may require an IBC approval, OGTR licence or Defence Export Contol permit: or no approvals and permits at all.

The number and type of permits required depends on the intended use of the DNA, its expression after transduction, the recipient country (Sanction Controls) and who is the recipient (Foreign Interferance and Defence Export Controls).

When deciding what permits will be required, consider all of the above.

 

Air transport training

Only persons who have completed an accredited Civil Aviation Safety Authority (CASA) approved training course may transport by air:

  • Genetically Modified Organisms
  • biological substances
  • patient specimens
  • infectious substances
  • dry ice

This includes interstate and international air transport.

The exception to this is the shipment of COVID vaccines. COVID vaccines, even if are GMOs, are exempt from IATA regulations. However, if the COVID vaccine is shipped in dry ice then professional training is required.

Probably the most efficient way to comply this IATA regulation (1) is to use a CASA trained courier. Remember however, that the courier must pack the goods. So organise to meet the courier in the loading dock and place your samples into the packaging, in sight of the courier. Couriers usually have a website form you can complete to ensure that the appropriate air waybill and other paper work are available at the time of packing.

1. 62nd Edition IATA Regulations

Carrying on an aeroplane

For information about what can be carried onto a passenger plane, search the CASA dangerous goods search engine. 

Taking 2.5 kg of carbon dioxide (dry ice) onboard a plane is usually permitted. The package must allow the release of gas. Each item of checked baggage must be marked 'Dry Ice' or 'Carbon Dioxide, Solid' and with the net weight of dry ice, or an indication that there is 2.5kg or less of dry ice. You must gain approval from your airline before flying.

Some airlines do NOT permit the carriage of ANY specimens in a passenger's carry-on or checked baggage under any circumstances. So check the airline's website, or give them a call, beforehand. In addition, you cannot keep any biological or chemical on your person (in your pocket, for example) on the plane.

However, most airlines allow Exempt Human and Animal Specimens on the plane in checked or carry-on baggage provided they are packed according to IATA regulations. (1)

Depending on the type and volume of embalming chemicals used, human and animal specimens may contain dangerous chemicals (such as flammable 70% w/w isopropyl alcohol or formaldehyde). Most airlines will allow specimens in ethanol or formaldehyde to be carried onto the plane. Qantas, for example, will allow 70% ethanol on the plane or checked luggage, provided the individual containers are smaller than 30ml, and the total volume is no more than 1L. Refer to Qantas medical equipment and specimens. Please refer to the Australian Quarantine and Inspection Service and the airline with which you will be flying for more information.

These items are subject to the usual biosecurity restrictions.

Check with your airline before you fly.

Cargo luggage

Dangerous Goods that are not permitted in passenger baggage may be accepted as dangerous goods freight or carried on the plane in the cargo (checked) luggage.

Notifiable Low Risk Dealings always need to be checked in with cargo luggage.

Infectious/high risk goods are NEVER permitted onto a passenger plane. They must go on a cargo-only aircraft.

On the plane paperwork

The same import permits, customs declarations, list of contents and packaging requirements that apply to goods shipped by courier or postal service are required when importing goods on a passenger plane.

 

 

 

Sending in the post

Items sent interstate or internationally by Australia Post are often shipped by aeroplane. So the same requirements for interstate and international courier transport, apply to shipment by post. 

Postage within South Australia will most likely be by road and/or train transport. Classification, packing and documentaton regulations still apply but there is no requirement to meet IATA nor CASA regulations. 

Australia Post's International Post Guidelines provides excellent and comprehensive information that is applicable to other courier shipment methods.  The searchable database for dangerous goods gives country specific information.

International postage of infectious substances Category A or B is prohibted by Australia Post.

Domestic postage of infectious substances Category B (only) is accepted by Australia Post.

Export of native wildlife and endangered species

Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)

Australia is a signatory to CITES to help protect native and endangered species from exploitation and extinction.

Under the Environmental Protection and Biodiversity Conservation Act, non-commercial trade exports and imports may be allowed ehere the wildlife specimens are to be used for one of the following purposes: research, education, exhibition, conservation breeding or propagation, household pets, personal items, and travelling exhibition. Approval under these provisions is conditional on completion of the online application form and granting of a permit by DAWE. 

Defence Export Controls

The export of tangible (physical) and intangible (electronic) goods, technology and information overseas may also be subject to Defence Export Controls. Severe penalties apply if goods subject to these controls are exported without a permit. 

Further Information

For further information: Department of Agriculture, Water and the Environment and the Department of Industry, Innovation and Science.

If you have any queries please contact: biosafety@unisa.edu.au