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S.L. 458.54 · Health Ethics Committee (Fees) (S.L. 458.54)

S.L. 458.54 ст. 2Fees.

ДействуетОфициальный текст

(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.