6. Biological specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

If you are exporting human body fluids, organs, and other tissues, you:

• do not need a TGA export permit if the volume of each individual container is 50 mL or less (even if the total volume of a shipment exceeds 50 mL)
• do need a TGA export permit when the volume of a container exceeds 50 mL

If you are exporting substances derived from human blood, you need a TGA permit regardless of the volume.

You do not need a TGA export permit to export:

• human breast milk
• human placenta (If you are planning to export human breast milk or placenta it is suggested that you contact your state or territory department of health regarding their requirements for handling and storage)
• human remains or human ashes - for more information see:
  1. Australian Government Department of Health website- external site
  2. Australian Border Force website- external site

Other export permit requirements not covered by a TGA export permit

• The National Health and Medical Research Council is responsible for issuing permits for the export of viable material (living tissues and cells) derived from human embryo clones, as a prohibited export under Regulation 8A of the Customs (Prohibited Exports) Regulations 1958.
• For more information on how to apply for a permit, please refer to the:
  • National Health and Medical Research Council website- external site

Responsibilities of applicants and exporters

As an applicant, you are responsible for:

1. Making an application in writing and providing accurate information on the application form.
2. Lodging the application with the Secretary of the Australian Government Department of Health.
3. Ensuring that a TGA export permit is obtained prior to export for human substances that require a permit.
4. Ensuring that the permit is provided to the Australian Border Force before or at the time of export.

As an exporter, you are responsible for:

1. Ensuring that the permit has been provided to the Australian Border Force (ABF)
2. Verifying that the information in the TGA export permit is accurate
3. Lodging an Export Declaration- external sitefor the goods being exported, in the Home Affairs Integrated Cargo System (ICS)
   • For information about lodging an Export Declaration, visit the ABF website.
4. Ensuring you are registered in the Home Affairs ICS with an Exporter Australian Business Number (ABN) or Customs Client ID (CCID) number
   • If you do not have an ABN you may need to apply for a CCID either through your licenced customs broker or by completing a B319 ICS Client Registration application form (pdf,809kb)- external site. This form can also be located through the 'Help and Support- external site' page on the ABF Website. Take your completed form and your ID documents to the nearest ABF office- external site.

The permit number for all TGA export permits begins with HBE followed by ten digits. This number is recorded by an ABF officer at the time of export.

Two types of permits

The TGA issues 2 types of permits for the purpose of exporting human substances:

• Single-use export permits 
  • Used for a single instance of exporting, and generally issued for an individual patient.
• Annual export permits
  • Used for organizations exporting multiple consignments per annum to a single destination.

Timeframes for permit issue

• Single-use export permits
  • Single-use export permits are generally issued within one working day of receiving an application.
• Annual export permits
  • Submit your application for an annual export permit at least one month prior to the expected date of export (or expiration of an existing annual permit).
  • Annual export permits are generally issued within one month of receiving an application.

Issuing of permits

Export permits are issued via email. Applicants are responsible for ensuring that the correct contact details and email address are entered into the application form.

Information needed for an application

• Single-use permits- To apply for a single-use permit you need to provide the following information:
  • Name, address, phone number, and current email address of the applicant
  • Exporter Australian Business Number (ABN) or Customs Client ID (CCID)
  • Number of the applicant
  • Good (substance) to be exported
  • Volume to be exported
  • A brief reason for the request, for example:
    • traveling overseas, research purposes, clinical use, therapeutic use, laboratory testing
  • Export destination (including country)
  • Date of export: the month of export if the exact date is not known
  • Patient name
  • Flight and/or courier details
• Annual permits- To apply for an annual permit you need to provide the following information:
  • Name, address, phone number, and current email address of the applicant
  • Exporter Australian Business Number (ABN) or Customs Client ID (CCID) number of the applicant
  • Good (substance) to be exported
  • A brief reason for the request
    • e.g. research purposes, clinical use, therapeutic use, laboratory testing
  • Name and address of overseas destination (including country)
  • Maximum quantity per consignment
  • Maximum number of consignments per permit period

You will need to make a separate application for each destination.

Application to export human substances

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

Please refer to Section 6.1 above.

6.3 Does the local authority require any specific documents for customs clearance?

Please refer to Section 6.1 above.