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Initial Required Information

As of 31 January 2023, the EudraCT application is available for the creation of third country files for trials conducted exclusively outside of the EU/EEA and part of a Paediatric Investigation Plan (PIP) and/or in scope of Article 46 of the Paediatric Regulation (EC) 1901/2006. If your PIP/Art 46 trial is going to be conducted in the EU/EEA, as well as in third country(ies), you need to perform a single submission through the Clinical Trials Information System

EudraCT Number

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.

Application hosted on behalf of the European Commission

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