The set of documents (the research file) you have to submit to the competent authority is the same as the file for submission to the reviewing committee. See the standard research file.
Information specific to research with a medicinal product is indicated in the standard research file with the symbol:
How to submit & addresses
- You must state the NL-number of your research on each separate submission (see the ABR form).
- Use a cd-rom or Eudralink for the primary submission.
- Save all documents separately onto the cd-rom or Eudralink (not in folders) and do not use zip-files.
- Ensure all documents are in pdf format. 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 in the digital research file in pdf format.
- Send the cd-rom together with the signed cover letter (on paper) by post to the competent authority or send an email with the reference to Eudralink to email@example.com / firstname.lastname@example.org.
- The digital cover letter must be signed if you submit via Eudralink.
- Emails with references to Eudralink will only be accepted if both the link and the documents are not protected by a password and if all documents are compiled in one zip-file.
- If you do not have a Eudralink account, you may create an account on the website of the EMA.
The competent authority will return incorrect submissions without processing them. Please also note that the competent authority does not send an acknowledgement of receipt.
In the case of submitting to the competent authority not all digital documents have to 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. Detailed explanatory note are provided per (sub)division . Documents specific to research with a medicinal product are marked by the symbol:
The correct coding and titles of your documents are important for efficient processing of your submission. See the list Coding and examples of document titles for digital submission. 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 submit your application to:
Central Committee on Research Involving Human Subjects (CCMO), email@example.com
F.a.o. the competent authority
P.O. Box 16302
2500 BH The Hague
If your research is being reviewed by the CCMO then the Ministry of Health, Welfare and Sport acts as competent authority.
You can submit your application to:
Ministry of Health, Welfare and Sport (VWS), firstname.lastname@example.org
F.a.o. Competent Authority (CA)
c/o Medicines Evaluation Board (MEB)
P.O. Box 8275
3503 RG Utrecht
Do you have any genereal queries concerning submission? Please send an e-mail to email@example.com.
Changes to documents during the primary submission
The submitting party often (has to) make(s) change(s) to certain documents before the reviewing committee (MREC or CCMO) can reach a positive decision. In the case of research with a medicinal product, the competent authority (CCMO or Ministry of Health, Welfare and Sport) may have already issued a 'No grounds for non-acceptance' as the review by the reviewing committee and the competent authority can occur simultaneously.
If the competent authority has already issued a 'No grounds for non-acceptance', then you do not have to send any updated documents to the competent authority which are deemed necessary for the primary submission to an accredited MREC or CCMO. There is one exception: documents concerning a change to the medication used in the study. This is because the competent authority always performs a search of the expected effects of the product in the EMA EudraVigilance database before it issues a ‘No grounds for non-acceptance’. A change to the medication can influence the expected effects, and therefore to the already issued No grounds for non-acceptance.
Extension 'No grounds for non-acceptance'
The ‘No grounds for non-acceptance’ issued by the competent authority is valid for one year. This means the ‘No grounds for non-acceptance’ will lose its validity when the inclusion of the first subject has not taken place within a year after the declaration is issued. If you wish to extend the validity of the ‘No grounds for non-acceptance’, you must file a request by e-mail (firstname.lastname@example.org), Eudralink or cd-rom with the competent authority, accompanied by the documents from section D (product information) of the standard research file.