EudraCT

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As of 31 January 2023, all new trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through CTIS, including the addition of EU/EEA countries to EudraCT trials.

This page is to be used by sponsors only in case they have to perform an amendment to a CTA XML file that was submitted before 31 January 2023 to the same National Competent Authority, but they have lost the original file (and therefore the CTA XML file cannot be "loaded" but needs to be created again).

In case a new EU/EEA-country needs to be added to a EudraCT trial, the EudraCT trial needs to be transitioned to CTIS first: please refer to Clinical Trials Regulation Q&A section 11 for more information.

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For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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