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).
Terms and conditions rates
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 2024: 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. A template invoice details is available for this purpose. These data will be used for billing purposes.
Converting ongoing research with a medicinal product subject to the Dutch WMO Act (under old laws and regulations) to CTIS (under CTR) is free of charge. Reviews taking place after the transition to CTR are covered by the CTR fees listed below.
| 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 additional Member State |
€ 4.880 |
€ 1.630 |
€ 2.440 |
€ 810 |
|
Part 1: National or multinational research with the Netherlands as reporting Member State (rMS) (excl. assessment of IMPD) |
€ 7.320 |
€ 2.440 |
€ 3.660 |
€ 1.220 |
|
Part 2: member state specific documents |
€ 2.440 |
€ 810 |
€ 1.220 |
€ 410 |
|
IMPD (for each unregistered product) for national and rMS research |
€ 2.440 |
€ 810 |
€ 1.220 |
€ 410 |
|
Substantial modification part 1** |
€ 1.710 |
€ 570 |
€ 800 |
€ 300 |
|
Substantial modification part 2 |
€ 570 |
€ 190 |
€ 300 |
€ 100 |
|
Substantial modification part 1 and 2 |
€ 2.280 |
€ 760 |
€ 1.100 |
€ 400 |
* 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.
** The IMPD rate applies additionally when an unregistered medicine is added via a modification.
Rates 2024: 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 |
€ 7.320 |
€ 2.440 |
€ 3.660 |
€ 1.220 |
|
IMDD/ Product information (for each unregistered product) |
€ 2.440 |
€ 810 |
€ 1.220 |
€ 410 |
|
Substantial amendment |
€ 610 |
€ 200 |
€ 320 |
€ 110 |
|
Substantial amendment |
€ 1.830 |
€ 610 |
€ 860 |
€ 320 |
|
Substantial amendment |
€ 2.440 |
€ 810 |
€ 1.180 |
€ 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.
** The IMPD rate applies additionally when an unregistered medicine is added via a modification.
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).