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Sponsors who are not based in the European Union (EU) must appoint a legal representative based in the EU.

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.