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 information on application procedure to CA is provided on the CCMO website in section: Home>Investigators>Research with a medicinal product & extra review competent authority>Primary submission to the competent authority
Additional Information
Information regarding ATMP and other involved authorities is provided on the CCMO website in section:
Home>Investigators>Types of research>Research on gene therapy/medicinal product with GMO.
Both reviews (EC and CA) can take place simultaneously
