In the Netherlands, national fees are set for medical-ethical review of research with a medicinal product, a medical device or a medical device for in-vitro diagnostics.
These are fees for the assessment of clinical studies into:
- Medicinal products: Research falling within the scope of the EU Clinical Trial Regulation 536/2014 (CTR) for research with a medicinal product. The fees for research files submitted via CTIS are collected by the CCMO.
- Medical devices: Research carried out for conformity purposes, article 62/74.2 of the EU Medical Device Regulation 2017/745 (MDR). For other research files falling within the scope of the MDR (MDR article 74.1 or 82) the fee of the review committee concerned applies instead of the national fee. These fees are collected by the relevant ethics committee (accredited MREC).
- In vitro diagnostic medical devices: Research within the scope of Article 58/70.2 of the EU In Vitro Diagnostic Regulation 2017/746 (IVDR). These fees will be collected by the relevant medical research ethics committee (accredited MREC).
Terms and conditions fees
No VAT is charged by CCMO for the assessment. An overview of all the conditions that apply to the fees below, can be downloaded via: Terms and conditions fees.
Fees 2026: review of research with a medicinal product (CTR)
For each initial clinical trial application and substantial modification, a document containing the invoice details must be submitted under 'Proof of payment of fee' for the Netherlands in the Form section in CTIS, using the mandatory template invoice details. These data will be used for billing purposes.
| Type of assessment | Commercial* research | Non-commercial* research | Resubmission** commercial research | Resubmission** non-commercial research |
|---|---|---|---|---|
| Part 1: multinational research with the Netherlands as concerned EU Member State (MSC) or as Additional Member State |
€ 5.340 |
€ 1.780 |
€ 2.670 |
€ 890 |
| Part 1: National or multinational research with the Netherlands as reporting Member State (RMS) (excluding assessment of IMPD) |
€ 8.010 |
€ 2.670 |
€ 4.005 |
€ 1.335 |
| Part 2: Member State-specific documents |
€ 2.670 |
€ 890 |
€ 1.335 |
€ 445 |
| IMPD (for each unauthorised product) for national and multinational trials with NL as RMS | € 2.670 | € 890 | € 1.335 |
€ 445 |
| Substantial modification part 1 *** |
€ 1.860 |
€ 620 |
€ 930 |
€ 310 |
| Substantial modification part 2 |
€ 630 |
€ 210 |
€ 315 |
€ 105 |
| Substantial modification part 1 and 2 |
€ 2.490 |
€ 830 |
€ 1.245 |
€ 415 |
* A commercial / non-commercial fee is applied based on the sponsor details in CTIS.
** The resubmission fee applies to the resubmission of the (complete) dossier after a previous withdrawal or lapsed application during the assessment phase, or after a negative decision. Resubmission usually involves the initial application, but may also be done other application types. Resubmission does not refer to submitting a response and/or modified or new documents in an ongoing assessment (RFI).
*** If a new unauthorised product is added via a substantial modification, the IMPD fee applies on top of the default SM fee. There is no fee for the administrative SM used to change the sponsor.
Fees 2026: review of research with a medical device (MDR) and a medical device for in-vitro diagnostics (IVDR)
| Type of assessment | Commercial research | Non-commercial research | Resubmission* commercial research | Resubmission* non-commercial research |
|---|---|---|---|---|
|
National research including Member State-specific documents |
€ 8.010 |
€ 2.670 |
€ 4.005 |
€ 1.335 |
|
IMDD/ Product information (for each unregistered product) |
€ 2.655 |
€ 885 |
€ 1.328 |
€ 443 |
|
Substantial amendment |
€ 663 |
€ 221 |
€ 345 |
€ 111 |
|
Substantial amendment |
€ 2.025 |
€ 675 |
€ 900 |
€ 338 |
|
Substantial amendment |
€ 2.655 |
€ 885 |
€ 1.328 |
€ 443 |
* A resubmission refers to the resubmission of the (complete) dossier after a previous withdrawal, lapsed submission during the assessment phase or after a negative decision. Resubmission may involve the primary submission, but also the dossier for a modification. It does not refer to the assessment of the response and/or modified or supplemented documents in an ongoing assessment.
Annual adjustment
The Ministry of Health, Welfare and Sport may adjust the fees annually, coming into force from 1 January of the following year. CCMO will announce the adjustment annually before 1 July of the preceding year.
Other medical research
Separate fees apply to the assessment of other medical research in the Netherlands. These fees differ per review committee (accredited MREC).