ECSubmissionOfApplication object

Responsible for study submission

Sponsor
Principal Investigator (if no sponsor related to study)

Guidance on study submission available

Yes

Guidance on study submission

Related information and required documentation for application is set out in Art 6 Regulation no 433/2004.

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 6 Regulation no 433/2004

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