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Regulation (EC) No 726/2004 of the European Parliament and of the CouncilShow full title
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
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- Revised 30/03/20190.64 MB
- Revised 28/01/20190.52 MB
- Revised 05/06/20130.92 MB
- Revised 04/12/20120.92 MB
- Revised 02/07/20120.92 MB
- Revised 06/07/20090.20 MB
- Revised 20/04/20090.20 MB
- Revised 30/12/20080.20 MB
- Revised 26/01/20070.20 MB
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Changes over time for: Article 84
Version Superseded: 20/04/2009
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Article 84U.K.
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 regulations adopted pursuant to it 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 no later than 31 December 2004. 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 on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with the authorisations. 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 87(2).
The Commission shall publish the names of the marketing authorisation holders involved and the amounts of and reasons for the financial penalties imposed.
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