Fees
UPDATE: There is no change to the National Office application fee schedule for 2025.
Note: All clinical trials authorised under the Clinical Trials Directive 2004 must have either ended or transitioned to the Clinical Trial Regulations by 30 January 2025. The National Office cannot accept any documentation related to clinical trials approved under the Directive that have not ended or transitioned after this date.
Effective as of 1 January 2024, the National Office is no longer charging fees for applications submitted by non-commercial sponsors; that is, where the sponsor is academic/not-for-profit funded.
This pragmatic change is to support and facilitate non-commercial research.
This change is in line with the fee changes introduced by the Health Products Regulatory Authority (HPRA: Public Consultation Section 6.2.2).
This move is further in line with the European initiative 'Accelerating Clinical Trials in the EU', which aims to identify challenges for non-commercial sponsors and offer pragmatic and harmonised solutions to support non-commercial sponsors.
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 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 or contact nrec-finance@nrec.ie if you have any queries.
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.
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 | No charge |
| Substantial Modifications of Clinical Investigations and Performance Studies | €300 | No charge |
| Appeal of NREC-MD Decision | €1,200 | No charge |
| 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 | No charge |
| Substantial Modifications of Clinical Trials of Investigational Medicinal Products | €400 | No charge |
| NREC-CT fees for applications submitted under the Clinical Trials Regulation (EU 536/2014). | Commercial[1] | Non-Commercial[2] |
| New Clinical Trials of Investigational Medicinal Products | ||
| Mono national/ Member state concerned (MSC) | €1,500 | No charge |
| Reporting member state (RMS) | €2,000 | No charge |
| Supplement – where Ireland subsequently becomes the Reporting member state for Mono national trial | €500 | No charge |
| Reporting member state – 2nd & subsequent waves | €500 | No charge |
| Substantial Modifications of Clinical Trials of Investigational Medicinal Products | ||
| Mono national/ Reporting member state/ Member state concerned | €400 | No charge |
| Appeal of NREC-CT Decision | ||
| Appeal of NREC-CT Decision | €1,200 | No charge |
[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 have been removed
[3] This includes Post-Market Clinical Follow-Up Studies for Medical Devices