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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) article 11 CELEX: 02007R1394-20190726 Labelling of outer/immediate packaging
By way of derogation from Articles 54 and 55(1) of Directive 2001/83/EC, the particulars listed in Annex III to this Regulation shall appear on the outer packaging of advanced therapy medicinal products or, where there is no outer packaging, on the immediate packaging. |