CASubmissionOfApplication object

Responsible for study submission

Sponsor
Legal representative

Prerequisites for submission

Positive opinion by relevant EC(s)

Guidance on submission of application

Details on the application procedure, along with the required documentation, are provided in Art 4-10 and Annex 1&2 of the Rulebook on Application 2011.

Applicable national legal framework/ Reference

Art 4-10 and Annex 1&2 of the Rulebook on Application 2011

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