Fees

Updated 05/01/2023

For applications submitted under the Clinical Trials Regulations (EU 536/2014), fees for submissions are to be paid via the Clinical Trials Information System (CTIS).

For applications submitted under the Clinical Trials Directive (EC No. 2001/20/EC), Medical Devices Regulation (EU 2017/745) and In Vitro Diagnostic Medical Devices Regulations (EU 2017/746), applicants must pay the relevant fee in advance of submission to the National Office for Research Ethics Committees. An applicant should complete the Payment Processing Form available below. Please see the Guidance for the Payment of Fees for more detail.

Please note, there are different fees for NREC-CT and NREC-MD. Please see the table below for details of fees.

NREC-MD fees for applications submitted under the Medical Devices Regulation (EU 2017/745) and In Vitro Diagnostic Medical Devices Regulations (EU 2017/746).Commercial[1]Non-Commercial[2]
New Clinical Investigations and Performance Studies[3]€1,500€150
Substantial Modifications of Clinical Investigations and Performance Studies€300€50
Appeal of NREC-MD Decision€1,200€100

 

NREC-CT fees for applications submitted under the Clinical Trials Directive (EC No. 2001/20/EC).Commercial[1]Non-Commercial[2]
New Clinical Trials of Investigational Medicinal Products€1,500€150
Substantial Modifications of Clinical Trials of Investigational Medicinal Products€400€50

 

NREC-CT fees for applications submitted under the Clinical Trials Regulation (EU 536/2014).Commercial4 Non-Commercial5
New Clinical Trials of Investigational Medicinal Products
Mono national/ Member state concerned (MSC)€1,500€150
Reporting member state (RMS)€2,000€150
Supplement – where Ireland subsequently becomes the Reporting member state for Mono national trial€500€150
Reporting member state – 2nd & subsequent waves€500€150
Substantial Modifications of Clinical Trials of Investigational Medicinal Products
Mono national/ Reporting member state/ Member state concerned€400€50
Appeal of NREC-CT Decision
Appeal of NREC-CT Decision€1,200€100

[1] Where the study is industry funded or sponsored, commercial fees apply

[2] Where the sponsor is academic/ not-for-profit funded, non-commercial fees apply

[3] This includes Post-Market Clinical Follow-Up Studies for Medical Devices

All payments must be made in full, in Euro and paid by credit transfer / electronic fund transfer (E.F.T.).

Applicants should include the related bank advice note when submitting their documentation to the relevant NREC for review.

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