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

Drug Master Files must be submitted in the electronic Common Technical Document (eCTD) format. Please review the relevant guidance pages to learn how to submit data in the eCTD format, compile and publish sequences in eCTD, and provide the necessary regional information.

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

Requests for eCTD exemptions will be considered by the TGA on a case-by-case basis. If you believe you qualify for eCTD exemption, please email eSubmissions@health.gov.au with a justification.

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