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.