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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:
- Customs (Prohibited Imports) Regulations 1956 and Customs (Prohibited Exports) Regulations 1958
- check the List of drug substances requiring permission to import and/or export for further guidance
- Quarantine Act 1908
- contact the Department of Agriculture for information regarding quarantine clearance
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
- Application for approval to import/export unapproved therapeutic goods for experimental purposes (pdf,248kb)
- Application for approval to import/export unapproved therapeutic goods for experimental purposes (Microsoft Word,129kb)
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:
- Six monthly report - export of unregistered therapeutic good(s) (pdf,117kb)
- Six monthly report - export of unregistered therapeutic good(s) (Microsoft Word,129kb)
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:
- Medicine export enquiries: tga.exports@health.gov.au
- Human substance export enquiries: tga.exports@health.gov.au
- Medical device export enquiries: devices@health.gov.au
- Unapproved therapeutic goods export application enquiries: tga.exports@health.gov.au
- Unapproved therapeutic goods enquiries: eps@tga.gov.au