Regulation (EC) No 1394/2007 Article 11

Labelling of outer/immediate packaging

Article 11

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.

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CitationArticle 11 of Regulation (EC) No 1394/2007 (LawPlayer, data as of 2026-07-04)

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