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’.
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04
CitationArticle 12 of Regulation (EC) No 1394/2007 (LawPlayer, data as of 2026-07-04)
