Amendments to Regulation (EC) No 726/2004
Article 27
Regulation (EC) No 726/2004 is hereby amended as follows: 1. 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.’; 2. Article 56 shall be amended as follows: (a) in paragraph 1, the following point shall be inserted: ‘(da) the Committee for Advanced Therapies;’ (b) 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)’; 3. the Annex shall be amended as follows: (a) the following point shall be inserted: ‘1a. 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 ) . ( *1 ) OJ L 324, 10.12.2007, p. 121 ’;" (b) 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.’