Regulation (EC) No 726/2004 is hereby amended as follows:

1. 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. 2.

   Article 56 shall be amended as follows:

   1. (a)

      in paragraph 1, the following point shall be inserted:

      1. (da)

         the Committee for Advanced Therapies;

   2. (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. 3.

   the Annex shall be amended as follows:

   1. (a)

      the following point shall be inserted:

      1. 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 products15.

   2. (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.