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eSubmission of Medicines

MEB

As from June 1st 2017, submission of regulatory information by applicants for marketing authorizations regarding human medicines must be submitted electronically (eSubmissions) to the Medicines Evaluation Board (MEB). All submissions have to be technically valid and must comply with the required format.

eSubmissions must meet the eCTD (electronic Common Technical Document) standard or the NeeS (Non eCTD electronic submission) specifications. Technical validation will be performed by MEB conform the common European criteria as published on the European eSubmission website.

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