CASubmissionFormat object

Format option(s)

Electronically on data carrier (CD/USB stick)
Data medium + cover letter to be sent by regular mail

Standard application form available

Yes

Standard application form

EudraCT Application Form (https://eudract.ema.europa.eu ) also available on BASG website

Standard application form - Additional information

The accompanying documentation is provided in:
L I205 Verzeichnis der erforderlichen Unterlagen (de)
L I211 List of documentation required (en)

Use of standard application form binding

Yes

Guidance on submission format available

Yes

Guidance on submission format

L I206 Leitfaden KP Einreichung (de)
L I209 Guidance CT submission (en)
L I205 Verzeichnis der erforderlichen Unterlagen (de)
L I211 List of documentation required (en)

Additional Information

The EudraCT application form (PDF and XML) and all documents required for assessment (Protocol, IB, IMPD, ...) need to be submitted in electronic form on an a data medium (e.g. CD).
The data medium and cover letter should be sent to the BASG by regular mail.
A paper version of the dossier will no longer be required as from 01.01.2016.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395