Cell-therapy due diligence for patients in the Netherlands
A country-specific starting point for checking product authorisation, trial oversight and cross-border follow-up. This page does not rank providers or recommend medical travel.
What the regulator can confirm
The Dutch Health and Youth Care Inspectorate explains the routes for ATMPs: an EU marketing authorisation is generally required, with defined routes for clinical research or a hospital exemption. The IGJ must approve preparation and use under the Dutch hospital-exemption route. A provider's registration or laboratory claim does not replace a product-specific record.
Ask for the exact intervention, authorised indication, manufacturer and IGJ, CBG or EMA reference. If travelling abroad, verify the foreign legal route and ensure that a Dutch clinician has the records needed for follow-up and adverse-event reporting.
Evidence to request before treatment
| Question | Document or identifier | Why it matters |
|---|---|---|
| What exactly is administered? | Product name, cell source, processing, dose and route | Evidence and legal status are product- and indication-specific. |
| What is the legal route? | Marketing authorisation, authorised trial number, or named exemption and authority | A clinic licence or registry listing does not by itself authorise a product. |
| Who manufactures it? | Legal manufacturer, site and authorisation scope | General references to GMP are not a substitute for a current, applicable record. |
| How are harms managed? | Consent form, adverse-event plan, insurance and emergency contact | Experimental status does not remove the duty to disclose and manage risk. |
| What happens after travel? | Written follow-up plan and named clinician | Cross-border care can complicate continuity and reporting. |
Conditions compared
Educational regulatory orientation, reviewed in 2026. Verify current records directly with the authority and seek independent medical advice.