Legal Representative

A sponsor company that does not have a subsidiary in the European Union and wants to carry out a clinical study in the EU must appoint a “Legal Representative” pursuant to Article 74 (1) of Regulation (EU) 536/2014 (CTR).

The now active CTR has broadened the rights and duties of such a Legal Representative. While under the previously applicable Clinical Trial Directive it would have been sufficient to have a “virtual office” in the EEA assuming the role of the Legal Representative, the new CTR clearly demands for an active Legal Representative that needs to fulfill a supervisory role and is constantly up-to-date on the current status of the clinical trial. Because according to Article 74 (1) CTR “Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation” and that all communication addressed to the legal representative shall be deemed as communication to sponsor.

Only one Legal Representative can be selected for a clinical trial, and the Legal Representative can be located in any of the EU member states to act as Legal Representative throughout the EU.

Similarly to the CTR, the Medical Device Regulation (EU) 2017/745 also introduced the need for a Legal Representative for investigations with medical devices in Article 62 (2).

According to applicable law in Switzerland and in the United Kingdom, a local sponsor representative has to be appointed for clinical studies conducted in these countries. This requirement applies to studies with investigational medicinal products and medical devices.

Our team provides you and your contracted local CRO's with sponsor representation services in Europe (EU, UK and Switzerland) required according to these Regulations.