Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.

EU Legal Representative (concerns only the EU)

According to Art. 19 of the EU directive 2001/20/EC, the sponsor or a legal representative of the sponsor must be established in the Community (this includes all EEA countries).

The EU legal representative does not endorse the sponsor’s responsibilities of initiating, managing and financing the clinical trial. The role of the EU legal representative is limited to civil and criminal liability: the competent jurisdiction of a specific member state, applying its own domestic law in terms of civil or criminal law, may engage the EU Legal Representative liabilities on behalf of the sponsor.

Only one legal representative can be appointed for a specific clinical trial.

A special power of attorney appointing the legal representative must be signed by the sponsor and included in the Clinical Trial Applications.