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Extended Impact Assessment of a Draft EC Regulation on Medicinal Products for Paediatric Use

Published 21 February 2005 - Updated 29 January 2010
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This impact assessment of the draft regulation on paediatric medicines was conducted by RAND Europe for the European Commission. 

The paper draws the conclusion that the EU's new regulation on medicinal products for paediatric use will cost money to industry, government and consumer but will improve the health of children and, on balance, the gains will outweigh the losses.

This document was put together by Wija J. Oortwijn, Edwin Horlings, Silvia Anton, Mirjam van het Loo and James P. Kahan, can be downloaded from the RAND website.

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