Import/export of unapproved therapeutic goods for experimental purposes
The Experimental Products Section (EPS) of the TGA is responsible for granting approvals for the exportation 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.
An application form is now available to assist in the process of obtaining 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 multiple countries for a period of twelve months. A complete new application is required to renew an approval after this twelve month period
- A complete new application is 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
Applicants should note that additional restrictions may be imposed on the importation and exportation of unapproved therapeutic goods through the following legislation:
- 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.
Clinical trials within Australia
For information regarding the import and supply of therapeutic goods for clinical trials within Australia, please refer to Clinical trials.
To apply, complete the application form below:
- Application for approval to import/export unapproved therapeutic goods for experimental purposes (pdf,125kb)
- Application for approval to import/export unapproved therapeutic goods for experimental purposes (Microsoft Word,137kb)
You will be required to submit six monthly reports for the previous approval period if these have not been submitted previously. A template for 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,134kb)
Completing the form
Ensure you complete ALL fields, indicating 'nil' or 'not applicable' if required.
The form must be signed and dated by the applicant.
Submitting an application
The completed application form and necessary attachments should be forwarded to us by:
Note: Only pdf and Microsoft Word documents are acceptable as email attachments.
We endeavour 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.
Note: Application forms that contain incomplete or incorrect information will require amendment and may result in delays in processing.
Contact details for enquiries
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|Postal address||Experimental Products Section
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606