MEB starts technical validation of electronic submissions as from 1 June 2017
Submissions concerning human medicinal products must be submitted electronically to the Medicines Evaluation Board (MEB). As from 1 June 2017, the MEB will start performing the technical validation of electronic submissions.
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 (Non eCTD electronic Submission). This applies for as long NeeS submissions are allowed in accordance with the eSubmission Roadmap.
The MEB uses the common European criteria for technical validation as published on the European eSubmission website.