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, 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. It is not required if the DMF is submitted in eCTD format.

The Drug Master File (DMF) Administrative Details Form is to be completed electronically. When submitted it will be sent to DMFinbox@tga.gov.au