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Medicines Act (Cap. 458) Health Ethics Committee (Fees) Regulations, 2009 (Ln 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:-

Title.

Fees.

Discounts.

(Fees) Regulations, 2009.

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.

Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper <.. image removed ..>

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