Submitting a Drug Master File (DMF)

This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA.

There are no fees associated with submitting or updating DMFs.

How to submit the DMF

It is the TGA's preference to submit the DMF in electronic Common Technical Document (eCTD) or Non eCTD electronic Submission (NeeS) format. The electronic submissions web page provides information and describes the requirements on how to submit these files to the TGA. Please visit Submitting data in the eCTD format and Submitting data in the NeeS format for further information.

Once the DMF is submitted in eCTD format, subsequent submissions should be in the eCTD format in order to maintain a lifecycle.

If not submitting in eCTD or NeeS, a DMF Administrative Details Form must be filled out (see below).

How to submit the DMF Administrative Details Form

This form is for stakeholders that are not submitting in eCTD or NeeS.

The Drug Master File (DMF) Administrative Details Form is to be completed electronically.

Complete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA. Complete all questions and press the 'submit' button at the end of the form.

Once the DMF is received by the TGA, an acknowledgement email that includes the TGA reference number will be sent to the DMF holder within 6 weeks.

For more information on DMFs please refer to:

• Guidance 11: Drug Master Files and Certificates of Suitability
• CTD Module 1 - 1.6 Master Files and Certificates of Suitability