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How to submit

Please note: The CCMO does not have access to the submission portal CESP

  • Please state the NL-number of your study for every separate submission (see the ABR form).
  • Send your submission (preferably by Eudralink) to bi@ccmo.nl/info-bi@cbg-meb.nl.
  • Send all documents separately  or in a zip file in Eudralink (not in folders).
  • Ensure all documents are unprotected pdf-files. It is not permitted to submit protected (pdf-) files, even if the password is provided.
  • Forms which have been saved in ToetsingOnline, such as the ABR form and the EudraCT Application Form, must be included as pdf-files in the digital research file.
  • Send an email containing the reference to Eudralink to bi@ccmo.nl / info-bi@cbg-meb.nl.
  • If you do not have a Eudralink account as yet, you may create an account on European Medicines Agency | (europa.eu).

Please note that the competent authority does not send an acknowledgement of receipt.

When submitting to the competent authority, not all digital documents needto be signed as long as you state in the cover letter to the competent authority that all necessary documents are signed by the authorised persons and will be presented to the reviewing committee (MREC or CCMO). Templates of cover letters can be found in the standard research file. 

The correct coding and titles of your documents are important for efficient processing of your submission. Please consult the list Coding and examples of document titles for the correct codes and examples of document titles. The document title should start with the two characters (letter + number) of the regarding documents in the standard research file. You are also required to give the version and date in the title. If you do not then there is the risk that the competent authority will view your submission as invalid and will return it, causing unnecessary delay of the processing of your request for review.

You can send your submission to CCMO as competent authority: bi@ccmo.nl

If your study is being reviewed by CCMO, then the Ministry of Health, Welfare and Sport (VWS) acts as competent authority. In that case, you may send your submission to VWS: info-bi@cbg-meb.nl.

Do you have any general queries concerning submission? Please send an e-mail to bi@ccmo.nl.

Please note: Emails containing references to Eudralink will only be accepted if both link and documents are not password-protected. Documents in Eudralink must be made available for at least three months.