Regulation (EC) No 1902/2006 of the European Parliament and of the Council
of 20 December 2006
amending Regulation 1901/2006 on medicinal products for paediatric use
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee,
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty1,
Whereas:
The measures necessary for the implementation of Regulation (EC) No 1901/20062 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 Commission3.
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.
It is necessary to amend Regulation (EC) No 1901/2006 accordingly,
HAVE ADOPTED THIS REGULATION: