Small and medium-sized enterprises developing an advanced therapy medicinal product may submit to the Agency all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC, for scientific evaluation and certification.
The Commission shall lay down provisions for the evaluation and certification of such data, in accordance with the regulatory procedure referred to in Article 26(2).
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 18 of Regulation (EC) No 1394/2007 (LawPlayer, data as of 2026-07-04)
