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

In the Netherlands, national rates 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 rates will apply from 1 January 2023 and will be collected by the relevant ethics committee (accredited MREC).

Rates 2023

No VAT is charged by CCMO for the assessment. An overview of all the conditions that apply to the rates below, can be downloaded via: Terms and conditions Rates.

Rates for reviewing research with a medicinal product and research with a medical device
Type of assessment Primary assessment for commercial research Primary assessment of non-commercial research Assessment resubmission* commercial research Assessment resubmission* non-commercial research

Low-rate research file:

  • CTR: part 1: multinational research with the Netherlands as concerned EU Member State (cMS) or additional Member State
  • MDR or IVDR: national or multinational research with the Netherlands as concerned Member State
€ 4.560 € 1.520 € 2.280 € 760

High-rate research file**:

  • CTR: part 1: National and multinational research with the Netherlands as reporting Member State (rMS)
  • MDR or IVDR: Coordinated assessment of multinational research with the Netherlands as coordinating Member State
€ 6.840 € 2.280 € 3.420 € 1.140

Research file ‘member state specific documents’:

  • CTR: part 2
  • MDR: member state specific documents (article 78(3), second paragraph)
  • IVDR: member state specific documents (article 74(3), second paragraph)
€ 2.280 € 760 € 1.140 € 380

Product information for national and rMS research:

  • CTR: IMPD (for each unregistered product)
  • MDR: IMDD (for each unregistered product)
  • IVDR: product information (for each unregistered product)
€ 2.280 € 760 € 1.140 € 380

Substantial amendment part 1***

€ 1.710 € 570 € 800 € 300

Substantial amendment part 2

€ 570 € 190 € 300 € 100

Substantial amendment part 1 and 2

€ 2.280 € 760 € 1.100 € 400

Safety assessments:

  • ASR/DSUR with the Netherlands as saMS
€ 2.850 € 950 N/A N/A

Safety assessments:

  • DSUR: research into the product is only carried out in the Netherlands
€ 1.140 € 380 N/A N/A

Safety assessments:

  • DSUR: the Netherlands is no saMS
€ 570 € 190 N/A N/A

* 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 an amendment. It does not refer to the assessment of the response and/or modified or supplemented documents in an ongoing assessment.

** These rates do not include the (re)assessment of an IMPD and/or IMDD for an unregistered product. Separate rates apply (see table).

*** The IMPD rate applies additionally when an unregistered medicine is added via an amendment.

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).