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Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
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Regulation (EC) No 726/2004 is hereby amended as follows:
in the first subparagraph of Article 13(1), the first sentence shall be replaced by the following:
‘Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community.’;
Article 56 shall be amended as follows:
in paragraph 1, the following point shall be inserted:
‘the Committee for Advanced Therapies;’
in the first sentence of the first subparagraph of paragraph 2, the words ‘paragraph 1(a) to (d)’ shall be replaced by ‘paragraph 1(a) to (da)’;
the Annex shall be amended as follows:
the following point shall be inserted:
‘Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products(1).’;
In point 3, the second subparagraph shall be replaced by the following:
‘After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.’
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