01.03.2016 - According to the Swissmedic publication of 1 January 2016, the agency must now receive Drug Master Files (DMF) and Active Substance Master Files (ASMF) no later than three days after it has received the accompanying applications. In connection with this requirement, Swissmedic would like to point out that DMF/ASMF must not be received more than seven calendar days before the accompanying application. If there is no application for a DMF/ASMF, a reminder will be sent to the authorisation holder giving them 120 calendar days to submit the application. If no application is received within 120 calendar days of the reminder being sent to the authorisation holder, Swissmedic will return the DMF/ASMF at the sender's cost if the DMF/ASMF was sent from Switzerland. If the DMF/ASMF was sent from abroad, it will be disposed of in a controlled manner at the end of the 120 days.
The guidance document Formal requirements and the form DMF for first authorisation/variation have been updated. The changes take immediate effect. The predecessor version of the form DMF for first authorisation/variation will still be accepted during a transitional period lasting until 31 May 2016.