Oprava nařízení Evropského parlamentu a Rady (ES) č. 1394/2007 ze dne 13. listopadu 2007 o léčivých přípravcích pro moderní terapii a o změně směrnice 2001/83/ES a nařízení (ES) č. 726/2004 (Úřední věstník Evropské unie L 324 ze dne 10. prosince 2007)

Corrigendum to 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 (Official Journal of the European Union L 324 of 10 December 2007 )

On page 131, Article 28, Amendments to Directive 2001/83/EC, point 4: for: 4.in Article 6(1), the first subparagraph shall be replaced by the following: No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007., read: 4.in Article 6(1), the first subparagraph shall be replaced by the following: No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric useOJ L 378, 27.12.2006, p. 1 . and Regulation (EC) No 1394/2007.