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