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As of 31 January 2023, all new initial clinical 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.
I want to start a new trial in the EU/EEA and have not submitted my initial application through EudraCT before 31 January 2023. Please take me to the CTIS portal.
I want to add a new EU/EEA-country to my EudraCT trial. This can be done after the EudraCT trial is transitioned to CTIS: please show me more information on transitional trials.
I want to load and amend the Clinical Trial Application XML file because I want to submit an amendment to the same National Competent Authority that received the relevant EudraCT initial clinical trial application before 31 January 2023.