Deadlines

The CTR foresees 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 time limit 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. 

Christmas clock stop

There is an informally agreed Christmas clock stop between 23 December and 7 January for all clinical trials, i.e national and multinational. The sponsor must indicate any objections against this clockstop to the rMS in time. There are no other clock stops within the procedures.