The CTR has strict timelines. The clock starts running the day after the application is submitted and follows the Central European Time (CET). The Netherlands uses CET.
Each phase, from validation, assessment and decision, has its own timeline for MSs and sponsors. The time limits are set in calendar days and follow the rules as set in Regulation 1182/71. This means that the due date can never fall on a weekend day or an official holiday. Neither can a time period be shorter than two consecutive working days. For multinational trials, official holidays of RMS and/or MSC are taken into account depending on the hard task of RMS/MSC . The timelines are visible in CTIS in the Timetable of an application.
Christmas clock stop
There is an informally agreed Christmas clock stop from 23 December until and including 7 January for all clinical trials, i.e. national and multinational. For all ongoing procedures, the timelines are stopped during this period.