Submitting electronic DMF/ASMF dossiers (US / CA / EU / CH)
This presentation is an overview of the primary requirements for submitting electronic DMF/ASMF applications across various ICH countries (US, Canada, EU and SwissMedic).
The topics included are:
1. What is a DMF/ASMF and what is its purpose?
2. What types of DMFs are in place?
3. Differences between the ICH countries
4. Differences between open and restricted parts (if applicable)
5. Electronic particulars concerning DMF submissions
6. Update on changed requirements