The following guideline is to be seen in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014. Since clinical trials can be designed as multi-centre studies potentially involving different member states, it is the aim of this guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.


Posted on the EMA website on 1 July 2016