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Import/export of unapproved therapeutic goods for experimental purposes

Related information

25 September 2021

The Exports Team of the TGA is responsible for granting approvals for the export from Australia of specified unapproved therapeutic goods for use solely for experimental purposes in humans under sections 19(1)(b), 32CK(1) or 41HB(1) of the Therapeutic Goods Act 1989.

You will need to apply for approval to import clinical trial goods for subsequent export or to export clinical trial goods manufactured in Australia.

Approvals are usually granted for multiple consignments for export to one or more countries for a period of twelve months. A new application is required to renew an approval after the twelve month period. A new application is also required to obtain approval to export to additional countries. A report detailing the quantity of goods that have been exported to each clinical trial site must be submitted to the TGA every six months

Additional requirements

Additional restrictions may be imposed on the import and export of unapproved therapeutic goods through the:

Applicants should also contact the relevant regulatory authority(ies) in the destination country(ies) for any importation requirements.

Application form

To apply, complete the application form below:

How to access a pdf or Word document

Completing the form

  • Ensure you complete ALL fields, indicating 'nil' or 'not applicable' if required.
  • Application forms that contain incomplete or incorrect information will require amendment and may result in delays in processing.
  • The applicant must sign and date the form.

Submitting an application

  • Email your completed application form and attachments as a single PDF document to Exports.

If you are submitting a six monthly make sure that you send this as a separate document.

Six monthly report

You are also required to submit six monthly reports for the previous approval period. The template for the six monthly reports is available below:

Submitting a six monthly report

Email your six monthly report as a single PDF document to Exports.

Only pdf and Microsoft Word documents are acceptable as email attachments.

Processing times

We aim to process approvals within 15 working days from the date of receipt.

However, there will be times where high demand may result in slightly longer processing times.

Contact us

Contact details for enquiring about exporting therapeutic goods: