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


Standard application form

European CT Application Form

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


Guidance on submission format

Related information on CT application procedure is available on the IMA website in section Home > Licences > Clinical Trials > Application.