In the Netherlands it is mandatory to also submit responses to questions regarding human medicinal products via electronic submission. The responses to questions should thus be included in the electronic dossier and should not be submitted in separate documents. Please note: not all correspondence with the MEB is related to the contents of the dossier - e.g. the correspondence about payment of invoices or an application for postponement of the period for responding to questions.
The MEB strongly prefers receiving responses to questions electronically via CESP. For the time being, you may submit your responses to questions about the contents of the dossier via CD, DVD, e-mail or Eudralink. However, you should always comply with the standards set for an electronic submission.
Responses to questions via e-mail or Eudralink must be sent to the following e-mail address: email@example.com. In the subject line the case number must be mentioned in the format of case number<space>[number]. Responses to questions not sent via Eudralink or via other e-mail addresses will not be taken into consideration.
If you are not a registered user of Eudralink, you can apply to the EMA for an account by filling in the Eudralink application form, which can be found on the EMA website. For further information please contact the Eudralink Helpdesk by e-mail firstname.lastname@example.org or by phone +44 207-418-8680 / +44 207-418-8698.
In the application form you are requested to submit your personal details and to provide the details of a referee. At the MEB, this is the head of the IT unit, Joris Kampmeijer. The details are as follows:
First Name: Joris
Last Name: Kampmeijer
MS Agency: CBG Agency/MEB
Country: The Netherlands
Phone Number: +31 (0)88 2248135