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

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