EU Legal Representation
According to Art. 74 of REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, it is required for every non-EU Sponsor to have a Legal Representative that shall be responsible for ensuring compliance with the Sponsor’s obligations pursuant to the Regulation, and shall be the addressee for all communications with the Sponsor provided for in the Regulation.
The same requirement is arising also from the Art. 62 of the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Only one Legal Representative can act on behalf of one Sponsor in one clinical trial. If the Sponsor is the same for different trials, it is not required to have only one Legal Representative located in the EU for all non-EU sponsored trials taking place in the EU.
GCT offers Legal Representation services in the EU for clients who do not have a registered office within the territory of the EEA.