CASubmissionOfApplication object
Responsible for study submission
Sponsor
Legal representative domiciled in the EU/EEA
Entitled to study submission
Sponsor
Legal representative domiciled in the EU/EEA
Guidance on submission of application available
Yes
Guidance on submission of application
L I206 Leitfaden KP Einreichung (de)
L I209 Guidance CT submission (en)
L I205 Verzeichnis der erforderlichen Unterlagen 01 (de)
L I211 List of documentation required (en)
National legal framework in place
Yes
Applicable national legal framework/ Reference
Art 40(1) AMG