In the Netherlands it is mandatory to submit an electronic dossier for medicinal products for human use. This electronic dossier should preferably be submitted via the Common European Submission Platform (CESP). Alternatively, the dossier can be submitted on CD or DVD. When submitting on CD or DVD, an originally signed paper copy of both the cover letter and, if applicable, the application form must be submitted.
Submission via CESP makes the parallel sending of CDs or DVDs as well as the submission letter and/or application form to the MEB unnecessary and even undesirable. This way of delivery applies to all (dossier) information: initial applications, variations, ASMFs, etc.
CESP is available to all EU Member States and marketing authorisation applicants or holders, for both human and veterinary medicinal products. You can apply for CESP via a so-called 'self-service model for user management'. This means that every company must appoint its own company administrator who can enable and maintain access of the employees of that company to CESP. To start registration of the company administrator, you must complete a form via the "Register" link on the CESP website.
For questions about application and the technical aspects of effecting the connection to CESP, please contact email@example.com. For specific questions concerning the Dutch situation regarding CESP please contact infoCESP@cbg-meb.nl.
The MEB only accepts electronic submissions that meet the eCTD standard (eCTD: electronic Common Technical Document) or the NeeS specifications (NeeS: Non eCTD electronic Submission). This applies for as long NeeS submissions are allowed in accordance with the eSubmission Roadmap. As from 1 June 2017, the MEB will start performing the technical validation of your electronic submission. If the dossier you have submitted is not technically valid, or does not comply with the prescribed format, it will not be processed.
How to submit
The preferred method of submission is via CESP. In case CESP is not used, the CD(s) or DVD(s) together with the originally signed paper copies of the cover letter and the application form can be submitted by post or by courier. Eudralink may only be used in the case of submitting additional information or responding to questions.
Please contact the Regulatory Information Centre via telephone number +31 (0)88 224 8000 in case of any questions.
The delivery address for an electronic submission sent by courier is:
Medicines Evaluation Board
Graadt van Roggenweg 500
3531 AH Utrecht