Clinical Trials (Amendment) Regulations, 2007

L.N. 248 of 2007

MEDICINES ACT

(CAP. 458)

Clinical Trials (Amendment) Regulations, 2007

IN exercise of the powers conferred by article 106 of the Medicines

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>–

The title of these regulations is the Clinical Trials

(Amendment) Regulations, 2007 and they shall be read and construed

as one with the Clinical Trials Regulations, 2004, hereinafter referred

to as “the principal regulations”.

Immediately after sub-regulation (2) of regulation 11 of the

principal regulations there shall be inserted the following new sub-

regulation>–

“(3) By way of derogation from sub-regulation (1), the

Agency shall make public part of the information on paediatric

clinical trials entered in the European database in accordance with

the provisions of Regulation (EC) No. 1901#2006 of the European

Parliament and of the Council of the 12 th December, 2006 on

medicinal products for paediatric use.”.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

Lm0.04 (€0.09)