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