CASubmissionFormat object
Format option(s)
Data carrier (USB key)
Paper hardcopy
Data carrier (CD-rom/DVD)
Preferred format
One paper hardcopy of the CTA and all data + CD ROM or USB flashdrive with all the documents
Standard application form available
Yes
Standard application form - Additional information
The relevant Checklist IMP (with or without marketing authorisation in the EEA) shall be completed and attached to the application (available on IMA website in section Clinical Trials > Application).
Guidance on submission format available
Yes
Guidance on submission format
Related information on CT application procedure is available on the IMA website in section Home > Licences > Clinical Trials > Application.
