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You are here: BAILII >> Databases >> Irish Statutory Instruments >> European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) (Amendment) Regulations S.I. No. 726/2022 URL: http://www.bailii.org/ie/legis/num_reg/2022/0725.html |
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Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 3rd January, 2023. | ||
I, STEPHEN DONNELLY, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving further effect to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 , hereby make the following regulations: | ||
1. (1) These Regulations may be cited as the European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) (Amendment) Regulations 2022. | ||
(2) The Principal Regulations and these Regulations may be cited together as the European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) Regulations 2021 to 2022. | ||
2. These Regulations shall come into operation on 1st January 2023. | ||
3. In these Regulations “Principal Regulations” means the European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) Regulations 2021 (S.I. 260 of 2021). | ||
4. The following Regulation is substituted for Regulation 20 of the Principal Regulations: | ||
“Fees | ||
20. (1) The following fees shall be payable by a sponsor to the relevant National REC: | ||
(a) €1,500 in respect of each application under Regulation 8(1), | ||
(b) €300 in respect of each application under Regulation 8(2), and | ||
(c) €1,200 in respect of each appeal under Regulation 17 (which fee shall be refundable if the appeal is successful). | ||
(2) Where a National REC is satisfied that an application relates to a non-commercial clinical investigation, at the discretion of the National REC— | ||
(a) the fee payable under paragraph (1)(a) may be reduced to €150, | ||
(b) the fee payable under paragraph (1)(b) may be reduced to €50, and | ||
(c) the fee payable under paragraph (1)(c) may be reduced to €100. | ||
(3) The National REC may recover, as a simple contract debt in any court of competent jurisdiction, from the person by whom it is payable, any amount due and owing to it as a fee payable under this Regulation.”. | ||
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GIVEN under my Official Seal, | ||
23 December, 2022. | ||
STEPHEN DONNELLY, | ||
Minister for Health. | ||
EXPLANATORY NOTE | ||
(This note is not part of the Instrument and does not purport to be a legal interpretation) | ||
These Regulations amend the European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) Regulations 2021. | ||
These Regulations amend the amount of fess payable in respect of applications for National Research Ethics Committee (“National REC”) review of a clinical investigation to be conducted in the State or for a National REC review of a substantial modification of a clinical investigation and appeals in respect of such applications. |