It is mandatory that submissions concerning human medicinal products are submitted electronically to the MEB. As from 1 June 2017, the MEB performs 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. The MEB carries out the technical validation in accordance with European harmonised standards.
The MEB only accepts electronic submissions (eSubmissions) that meet the eCTD standard (eCTD: electronic Common Technical Document) standard or the NeeS specifications (NeeS: Non eCTD electronic Submission). This applies for as long NeeS submissions are allowed in accordance with the eSubmission Roadmap.
The MEB's technical validation comprises of two parts. First, the MEB manually checks whether your cover letter adheres to the required standards. Second, your submission is validated using EURSvalidator. Your case contact will be informed by e-mail of the outcome of our technical validation. This e-mail message contains a technical validation report.
Rejection also occurs in situations where a serious defect (such as a virus or unreadable CD) or password protection is encountered. In these cases your case contact will be informed by phone or e-mail.
Submissions via the Centralised procedure are not part of the technical validation by the MEB. This is the sole responsibility of the European Medicines Agency (EMA). In case the MEB encounters serious defects, the MEB will inform the EMA accordingly.