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Regulation (EC) No 1394/2007 of the European Parliament and of the CouncilShow full title
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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Article 13Package leaflet
1.By way of derogation from Article 59(1) of Directive 2001/83/EC, the package leaflet for an advanced therapy medicinal product shall be drawn up in accordance with the summary of product characteristics and shall include the information listed in Annex IV to this Regulation, in the order indicated therein.
2.The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
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