*From 31 January 2023, sponsors must use the Clinical Trials Information System to create an initial application for a new clinical trial to be conducted in the EU/EEA. Therefore, for PIP/Art 46 trials to be conducted in the EU/EEA, and for PIP/Art 46 trials to be conducted in both the EU/EEA as well as in third countries, a single application must be submitted through the Clinical Trials Information System .