Import/export of unapproved therapeutic goods for experimental purposes

Related information

5 August 2015

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.

Please note:

  • 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

Additional requirements

Applicants should note that additional restrictions may be imposed on the importation and exportation of unapproved therapeutic goods through the following legislation:

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.

Application form

To apply, complete the application form below:

How to access a pdf or Word document

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:

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:

TGA contact details
Email (preferred) eps@tga.gov.au
Fax
  • Within Australia: 02 6232 8112
  • Outside Australia: +61 2 6232 8112

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

Processing times

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

TGA contact details
Email eps@tga.gov.au
Phone
  • 1800 020 653 (freecall within Australia)
  • +61 2 6232 8644

Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:

  • TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653
  • Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 020 653
Fax
  • Within Australia: 02 6232 8112
  • Outside Australia: +61 2 6232 8112
Postal address Experimental Products Section
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia

Forms

How to access a pdf or Word document