Drug Master File (DMF) - Administrative Details

15 May 2015

This form is to be used by industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA, It is not required if the DMF is submitted in eCTD format.

This form should be completed in its entirety when submitting a new DMF to TGA or when updating an existing DMF already held by the TGA. There are no fees required when submitting or updating a DMF.

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

When submitted it will be sent to DMFinbox@tga.gov.au.

Further information regarding DMFs can be found within Guidance 11: Drug Master Files and Certificates of Suitability.

How to submit the Drug Master File (DMF) Administrative Details Form

Complete all questions and press the 'submit' button at the bottom of the page.

If the request is for a New DMF, you will be advised by email of the DMF number once the TGA administration process has been completed.

How to submit the Drug Master File (DMF)

Please submit the Drug Master File (DMF) in eCTD or NeeS format. The electronic submissions web page describes the requirements including how to send it to the TGA.

Note, once the DMF is submitted in eCTD format, all subsequent submissions should be in eCTD format in order to maintain the lifecycle.

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

Also note: A copy of the Drug Master File (DMF) Administrative Details Form is not required to be submitted with the DMF but eCTD or NeeS format submissions require a cover letter as part of the submission and that can be used when sending us the electronic media.