K2. Overview list of competent authorities

If the research is also being carried out in other countries of the European Union, an overview of competent authorities to which the protocol has been submitted must be included. Additionally, a copy of the decision made by foreign MRECs and/or competent authorities must be included, if available.

If a research has been reviewed in the Voluntary Harmonisation Procedure (VHP) the correspondence (all the questions by the participating member states and the response of the applicant) and the VHP decision must also be submitted.