HEALTH ETHICS COMMITTEE (FEES) REGULATIONS

HEALTH ETHICS COMMITTEE (FEES)

SUBSIDIARY LEGISLATION 458.54

HEALTH ETHICS COMMITTEE (FEES)

REGULATIONS

23rd January, 2009

LEGAL NOTICE 29 of 2009.

The title of these regulations is the Health Ethics

Committee (Fees) Regulations.

(1) There shall be charged and collected by the Health

Ethics Committee the following fees for any clinical trial on

(a)

investigational medicinal products ........

€1,000

(b)

medical devices .....................................

€1,000

(c)

combination products ............................

€1,200

(d)

other .....................................................

€1,000

(2)

(a) The fee to be charged by the said Committee for non-

interventional studies shall be €500.

(b) The fee to be charged for amendments to clinical trials

and non-interventional studies shall be €100.

(c) In the case of academic trials, the fee to be charged

shall be 25% of the fee charged in respect of such trial

or study.

Without prejudice to the fees referred to in these

regulations, the Health Ethics Committee may discount any fee

when the medicinal product falls under the category of orphan

drugs, or is being investigated for a paediatric indication, or in the

case of studies which are not covered by any commercial

sponsorship.