Considerations on COM(2006)640 - Amendment of Regulation xxx/2006 on medicinal products for paediatric use

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dossier COM(2006)640 - Amendment of Regulation xxx/2006 on medicinal products for paediatric use.
document COM(2006)640 EN
date December 20, 2006
 
table>(1)The measures necessary for the implementation of Regulation (EC) No 1901/2006 (2) should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (3).
(2)In particular, the Commission should be empowered to define further the grounds for granting a deferral for the initiation or completion of some or all of the measures in the paediatric investigation plan and to specify the maximum amounts as well as the conditions and methods for collection of the financial penalties for infringement of the provisions of Regulation (EC) No 1901/2006 or the implementing measures adopted pursuant to it. Since these measures are of general scope and are designed to supplement Regulation (EC) No 1901/2006 by the addition of new non-essential elements, these measures should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(3)It is necessary to amend Regulation (EC) No 1901/2006 accordingly,