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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  12

CELEX:  02007R1394-20190726

Special immediate packaging In addition to the particulars mentioned in Article 55(2) and (3) of Directive 2001/83/EC, the following particulars shall appear on the immediate packaging of advanced therapy medicinal products:
(a) the unique donation and product codes, as referred to in Article 8(2) of Directive 2004/23/EC;
(b) in the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.