CASubmissionOfApplication object

Responsible for study submission

Sponsor
Legal representative domiciled in the EU/EEA

Guidance on submission of application available

Yes

Guidance on submission of application

Further details concerning the application and the required documents are listed in section 7 GCP-V (e.g. EudraCT number confirmation etc.) and on the BfArM website (detailed guidance is provided in German, some in English) such as the guidance "3. Bekanntgabe zur klinischen Prüfung von Arzneimitteln am Menschen"

Applicable national legal framework/ Reference

Section 7 GCP-V

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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