esubmission
Medicinal products have to be granted marketing authorisation by
the Medicines Evaluation Board (MEB) before they can be placed on
the market. A dossier must be submitted to the MEB. This dossier
must comply with European requirements. For more information on
these requirements see the Notice to Applicants.
Submitting a dossier
In the Netherlands it is required to submit an electronic
dossier for medicinal products for human use. The full electronic
dossier should be available on CD or DVD. Furthermore originally
signed paper copies of the cover letter and the application form
have to submit along with the electronic dossier.
Electronic submission
The MEB only accepts electronic submissions that meet the eCTD
standards and the NeeS (Non eCTD electronic Submission)
specifications. For more information concerning electronic
submission see the European
eSubmission website.
Technical validation
As from January 1st 2010 the MEB will
technically validate your submission. The MEB will step by step
work towards a full compliance policy regarding the adherence to
the required submission standards. To assist applicants in gaining
experience with these standards the MEB will provide feedback on
the outcome of our technical validation. Applicants should use this
feedback to improve their adherence to the required standards for
subsequent submissions. You can download the validation software used by the
MEB for free via the EXTEDO website. For further
information go to
Regulatory affairs > eSubmission > Technical validation
policy.
How to submit
The usual, official method of submission is by post or by
courier, or possibly via Eudralink when submitting additional
information or responding to questions.
Please contact Information Processing on telephone number +31
(0)88 224 8416 in case of any questions.
Delivery address
The delivery address for all documents sent by courier is:
Medicines Evaluation Board
P.O. Box 8275
3503 RG Utrecht
The Netherlands