Dutch MEB starts technical validation of electronic submissions

As from 1 June 2017, the Dutch Medicines Evaluation Board (MEB) introduced technical validation of electronic submissions.

All dossiers that fail validation, do not comply with the prescribed format or have a “serious defect” will be rejected.  Serious defects include files that are password-protected, an unreadable CD or the detection of a virus.

The MEB will carry out their validation following the common European criteria for technical validation as published on the EU eSubmission website.

To validate an application, the MEB will first manually check the cover letter meets the required standards.  Then they will use EURSvalidator to validate the submission.

The agency will advise the case contact by e-mail of the outcome of the technical validation.

To access the announcement, click here.