The Netherlands is a major European hub for life sciences, pharmaceuticals, and medical devices, offering excellent opportunities for global manufacturers with its innovative ecosystem and full EU single market access.
The Medicines Evaluation Board (MEB – College ter Beoordeling van Geneesmiddelen, CBG-MEB) is the national competent authority in the Netherlands responsible for assessing and authorizing medicines, while the Health and Youth Care Inspectorate (IGJ) and notified bodies oversee medical devices. As an EU Member State, the Netherlands fully implements centralized procedures via EMA for medicines and MDR/IVDR for medical devices, with MEB managing national procedures, decentralized/mutual recognition procedures, Dutch language requirements, and local compliance oversight. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate the Netherlands’ EU-harmonized framework efficiently, prepare compliant submissions (including Dutch labelling), secure timely approvals, and ensure sustained compliance in this key Benelux and EU market.
Get Netherlands Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Netherlands-specific adaptation, scientific/technical review, and quality assurance for MEB/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via MEB and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to MEB, ethics committee coordination, and regulatory support for clinical trials in the Netherlands.
Dutch QPPV/local contact person services, PSUR/PBRER submissions to MEB/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and MEB/IGJ registration/oversight compliance in the Netherlands.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per MEB/IGJ and EU requirements.
Dutch labelling review, Blue Box/EEA requirements, mock-ups, readability testing, and MEB approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with MEB and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), MEB scientific advice preparation, and up-to-date Dutch/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in the Netherlands — from MEB/EMA submissions and MDR/IVDR compliance to pharmacovigilance, Dutch labelling, and sustained EU market success.
Contact Our Netherlands Regulatory Experts