Sponsor's legal representative

If the sponsor is not established in the EU/EEA, a legal representative of the sponsor has to be established in the EU/EEA (article 74.1). See also question 5 of the Q&A CTR.

Member States may choose not to require the establishment of a legal representative, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical trial (CTR articles 74.2 and 74.3). This contact person shall be the addressee for all communications with the sponsor. The tasks and responsibilities of the contact person should be described in a contract or in a letter of authorisation.