Our Rates

On 31 January 2022, the CTR will enter into force. The Minister of Health, Welfare and Sport has set the rates for the medical-ethical assessment in the Netherlands of research under the EU
regulation for drug research.

These rates can be found on the CCMO website here
The Ministry of Health, Welfare and Sport can adjust the rates annually.

These national rates apply to assessments by all accredited METCs authorised to assess drug research and the CCMO. If a study is submitted via the ECTR (CCMO), the invoicing also goes via the CCMO. During the first year, clients can opt to have drug research reviewed under the current legislation and regulations rather than under the CTR. The BEBO Foundation has opted in this case to bring the rates into line with the CTR rates as of 31 January 2022. We use the submission date to determine the tariff to be charged.  This also applies to submissions of ongoing studies, e.g. in case of an amendment or DSUR. The following should be taken into account:

    1. The “High-rate research file” applies to international research which is assessed according to current legislation and regulations, because in this case the BEBO Foundation conducts the assessment entirely on its own.
    2. The fee for CTR part 2 is charged for all studies, because under the current assessment system this is always part of the initial submission package.
    3. The subscription fee will lapse on 31 January 2022. However, there will be a fee for assessing a DSUR.

For research that is assessed according to current legislation and regulations, two rates apply instead of three rates when it is assessed under the CTR. This concerns the following two options:

    1. DSUR: €500
    2. DSUR: €1000 when the substance is examined in a study in the Netherlands only.

The subscription fee charged in the year preceding the DSUR for the study in question will be deducted from the invoice for the DSUR.

The prices do not include VAT.

Rates up to and including 30 January 2022

The rates below apply up to and including 30 January 2022.

The MREC of BEBO foundation divides submitted protocols into different levels of complexity. We charge different rates for these levels. The division into the different levels of complexity is done as follows:

Type Complexity
A
  • Issue of a non-WMO statement (upon assessment whether or not subject to WMO)
B
  • Research with a drug that is already registered
  • Research with an unregistered study drug, where this study drug has previously been reviewed by the MREC of the BEBO foundation in another research file
C
  • Research with an unregistered study drug that has not previously been reviewed by MREC of BEBO foundation
  • General experimental research, also with products other than medicines (e.g. food additives)
D
  • A combination of 3 or more C studies in one protocol
  • First in Human (FIH) studies with biologicals

Type of review rate excl. vat
A (non-WMO studies) € 500,-*
A (non-WMO studies to be discussed in meeting) € 1.000,-*
B protocol € 5.400,-*
C protocol € 7.200,-*
D protocol € 8.800,-*
Review of substantial amendments by the chairman (and two other MREC members if required) € 400,-
Review of substantial amendments by the chairman (and more than two MREC members if required) € 800,-
Review of substantial amendments in a meeting € 2.700,-
Subscription rate per 6 months € 250,-
*This is a indication, the rates depend on the size and type of protocol and the phase of the study.

Cancellation policy

If a time slot has been reserved at a meeting for a study and the study is rescheduled / canceled on or after the submission date, we will charge you the full review rate.

If the study is rescheduled / canceled up to 7 days before the submission date, we will charge you 50% of the review rate.

Subscription fee for long-term studies

The subscription fee is a fee for the management of your research file (this includes, for example, non-substantial amendments, archiving and, where necessary, assessing SUSAR’s, SAE’s, safety reports, progress reports and final reports). This applies to studies lasting six months or more.

This fee is € 250,- per six months (you do not have to pay upfront, invoice will follow afterwards).

We will charge the fee starting from the date of approval of the study. We will stop charging upon notification that the study has ended in the Netherlands.

If the study ends before the subscription fee is due, you will not receive an invoice.

MREC Assen