(1) An applicant may withdraw his or her application at any time before the opinion or authorization and the reason for such withdrawal shall be expressly disclosed to the Ethics Committee or National Competent Authority.
(2) The application may be resubmitted after a withdrawal or following the refusal or the application, and the resubmitted application must make reference to the previous application, highlight the changes as compared to the previous application and, if applicable, specify how any unresolved issues in the previous application have been addressed.
(3) Where an applicant intends to make any substantial modification subsequent to the opinion or authorization of the clinical trial, he or she shall consider how such changes may affect the rights, safety, dignity, well-being and confidentiality of the subject.