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) (c. 1394)

CHAPTER 8 GENERAL AND FINAL PROVISIONS

Article 27 Amendments to Regulation (EC) No 726/2004

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:

• ‘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:

• ‘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).’;

(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.’

(1)

OJ L 324, 10.12.2007, p. 121’;