Bioequivalence and Bioavailability Forum

Additionally in the European Commission "Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial" in the list of reuiqred documents under 1.5 stands Copy of ethics committee opinion in the MS concerned when available
In this context you will be anyway expected to submit to the Regulatory Authority the negative opinion of the first EC as well.