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2 décembre 2009
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Le Parlement approuve la proposition de directive sur les médicaments pédiatriques[en

Publié: jeudi 8 septembre 2005   

Le Parlement s'est prononcé à une écrasante majorité en faveur d'une proposition de directive visant à encourager le développement de médicaments adaptés aux besoins spécifiques des enfants. 

The European Parliament plenary has confirmed the Parliament Enviornment Committee's (ENVI) stand (see EurActiv 15 July 2005) and voted in favour of the paediatric medicines directive. 

The directive, the aim of which is to guarantee that medicines administered to children are suitable for them, requires pharmaceutical companies to conduct clinical trials involving children before authorisation of drugs. As compensation for these extra costs and as incentive for more R&D, the companies will be granted a six-month extension of their patent.

The Parliament also backed the ENVI Committee's wish to see the European Medicines Agency (EMEA) establish a network of researchers to avoid duplicating research or tests on children and called for the creation of a special EU programme for research into medicines for children, to be called MICE (Medicines Investigation for the Children of Europe).

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