Fees for reviewing research with a medicinal product and research with a medical device

In the Netherlands, national fees are set for medical-ethical review of research with a medicinal product, a medical device and a medical device for in-vitro diagnostics.

These are fees for the assessment of clinical trials into:

  • Medicinal products: Research files 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 files 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 files within the scope of Article 58/70.2 of the EU In Vitro Diagnostic Regulation 2017/746, also known as the In Vitro Diagnostic Regulation (IVDR). These fees will apply from 1 January 2023 and will be collected by the relevant 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 2025: 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 the 'Proof of payment of fee' 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

€ 5.070

€ 1.690

€ 2.535

€ 845

Part 1: National or multinational research with the Netherlands as reporting Member State (RMS) (excluding assessment of IMPD)

€ 7.620

€ 2.540

€ 3.810

€ 1.270

Part 2: Member State-specific documents

€ 2.520

€ 840

€ 1.260

€ 430

IMPD (for each unregistered product) for national and multinational trials with NL as RMS

€ 2.520

€ 840

€ 1.260

€ 430

Substantial modification part 1***

€ 1.770

€ 590

€ 885

€ 310

Substantial modification part 2

€ 600

€ 200

€ 300

€ 100

Substantial modification part 1 and 2

€ 2.370

€ 790

€ 1.185

€ 420

* A commercial / non-commercial fee is applied based on the sponsor details in CTIS.

** 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.

*** If a new unauthorised product is added via a substantial modification, the IMPD fee applies on top of the default SM fee.

Fees 2025: 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

€ 7.620

€ 2.540

€ 3.810

€ 1.270

IMDD/ Product information (for each unregistered product)

€ 2.520

€ 840

€ 1.260

€ 430

Substantial amendment
(changes to member state specific documents)

€ 630

€ 210

€ 345

€ 115

Substantial amendment
(other changes)

€ 1.920

€ 640

€ 900

€ 300

Substantial amendment
(changes to member state specific documents and other changes)

€ 2.520

€ 840

€ 1.260

€ 430

* 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).