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Regulation (EC) No 1901/2006 of the European Parliament and of the CouncilShow full title
Regulation (EC) No 1901/2006 of the European Parliament and of the Council 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 (Text with EEA relevance)
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Article 49
1.Without prejudice to the Protocol on the Privileges and Immunities of the European Communities, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedures laid down in Directive 2001/83/EC and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive.
Member States shall inform the Commission of these provisions by 26 October 2007. They shall notify any subsequent alterations as soon as possible.
2.Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
3.At the Agency's request, the Commission may impose financial penalties for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedure laid down in Regulation (EC) No 726/2004. The maximum amounts as well as the conditions and methods for collection of these penalties shall be laid down in accordance with the procedure referred to in Article 51(2) of this Regulation.
4.The Commission shall make public the names of anyone infringing the provisions of this Regulation or of any implementing measures adopted pursuant to it and the amounts of, and reasons for, the financial penalties imposed.
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