Submissions for medicinal products for humans must be submitted electronically to the MEB. 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.
As from 1 January 2019 the MEB will only accept electronic submissions (eSubmissions) which comply with the eCTD standard (eCTD: electronic Common Technical Document) and, by doing so, is following the HMA eSubmission Roadmap. The MEB applies the general European criteria for technical validation which can be found on the European eSubmission website. For national procedures the NeeS standard (NeeS: Non eCTD electronic Submission) is still going to be accepted, in accordance with European agreements, for some time to come in special situations. This applies to ongoing regulatory activities which are to be continued after 1 January 2019. For more information see the Q&A on this subject (Q&A on mandatory eCTD in National Procedures (NP)) on the European eSubmission website.
Contrary to general European policy in this area, the MEB has aligned itself with the member states that prefer receiving changes that apply to the Netherlands via national procedures in eCTD. Examples include: MAH transfer, change of local representatives, etc. For more information see: CMDh eSubmissions.
Your contact person will then be informed by email of the result of our technical validation. This email message contains a report of the technical validation.
Rejection occurs in situations of serious deficiencies (such as the presence of a virus or an unreadable CD) or if a security password has been set. In such instances your contact person will be informed by telephone or by email.
Submissions via the centralised procedure are not part of the MEB's technical validation. This is because this part falls under the responsibility of the European Medicines Agency (EMA). If the MEB comes across serious deficiencies, the MEB will inform the EMA accordingly.