Health Ethics Committee (Fees) Regulations, 2009

L.N. 29 of 2009

MEDICINES ACT

(CAP. 458)

Health Ethics Committee (Fees) Regulations, 2009

IN exercise of the powers conferred by article 106(q) of the

Medicines Act, the Minister of Social Policy, with the concurrence

of the Minister of Finance, the Economy and Investment, has made

the following regulations:-

The title of these regulations is the Health Ethics Committee

(Fees) Regulations, 2009.

(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.

€0.09