The Dutch Medicines Evaluation Board (CBG-MEB) is modernising the registration systems it uses to process marketing authorisation applications and manage regulatory dossiers. The goal: more efficiency, better data exchange with European databases and a foundation for future digital developments. If you hold or apply for a marketing authorisation in the Netherlands, the changes affect your day-to-day submissions as of May 2026.
What is changing
- New applications receive a longer case number generated by the new assessment system.
- System-generated emails contain a unique tracing number: keep it in all correspondence so it links automatically to the correct procedure.
- Official communications, licences and advice documents are issued with a digital signature.
- Submission routes are streamlined: applications can only be submitted via the Common Repository or CESP, while email and Eudralink are being phased out.
The new system will also enable automated processing of dossiers through electronic application forms (eAFs) and improve connectivity with EMA databases such as the Product Management System (PMS) and the Unified Product Database (UPD).
What this means for applicants
The changes should simplify regulatory processes in the long run, but they raise the bar on administrative precision now. Make sure your registration dossiers, submission procedures and lifecycle management practices align with the updated requirements: submission formats, sequence management and details such as the tracing number all matter more than before.
How MPCA can help
We support companies throughout the regulatory lifecycle: registration dossier development, eCTD preparation and submission, CESP and Common Repository submissions, variations and renewals, and regulatory strategy. See also the CBG-MEB’s own overview of the new registration systems.
This article is for general information and reflects the situation at the time of writing. Always consult the official CBG-MEB and EMA publications for binding requirements.