Regulation (EC) 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.OJL 378/1, 27.12.2006, as amended by REGULATION (EC) No 1902/2006.

Published by European Parliament and of the Council of the European Union

Medicinal ProductsPaediatric UseĀ 

This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC.

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