Fees

UPDATE: The updated National Office ethics application fee schedule for 2026 is published below.

For applications submitted under the Clinical Trials Regulations (EU 536/2014), fees for submissions are 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. Note, a new fee schedule will come into effect on 1 Feb 2026, as set out below. 

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.

Current

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]€1,500No fee
Substantial Modifications of Clinical Investigations and Performance Studies€300No fee
Appeal of NREC-MD Decision€1,200No fee

 

Effective 1 Feb 2026

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]€1,650No fee
Substantial Modifications of Clinical Investigations and Performance Studies€550No fee
Appeal of NREC-MD Decision€2,000No fee

 

 

Effective 1 Jan 2026

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)€1,650No fee
Reporting member state (RMS)€2,200No fee
Supplement – where Ireland subsequently becomes the Reporting member state for Mono national trial€550No fee
Reporting member state – 2nd & subsequent waves€440No fee
Substantial Modifications of Clinical Trials of Investigational Medicinal Products
Mono national/ Reporting member state/ Member state concerned€550No fee
Appeal of NREC-CT Decision
Appeal of NREC-CT Decision€2,000No fee

Effective as of 1 January 2024, the National Office no longer charges fees for applications submitted by non-commercial sponsors; that is, where the sponsor is academic/not-for-profit funded. This pragmatic change helps to support and facilitate non-commercial research.

This 'no fee' approach for non-commerical applications is aligned with:

  • the Health Products Regulatory Authority fee schedule (HPRA: Fees for Medicines for Human Use).
  • 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.

 

[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

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