Time limit for submitting Drug Master Files and Active Substance Master Files shortened

01.01.2016 - Swissmedic must now receive Drug Master Files (DMF) and Active Substance Master Files (ASMF) no later than three days (formerly 14 days) after it has received the accompanying applications. As of 1 April 2016, formal objections will be issued in relation to any application for which the DMF/ASMF is not received within three days of receipt of the application. The guidance document Formal requirements has already been modified accordingly.

https://www.swissmedic.ch/content/swissmedic/en/home/news/mitteilungen/archive/time-limit-for-submitting-drug-master-files-and-active-substance.html