My bookmarksSign up free

Regulation (EC) No 1394/2007 Article 4

Regulation (EC) No 1394/2007 Article 4

Clinical trials

Article 4

1.   The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products. 2.   The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.

Read the full instrument → · Read this in context: CHAPTER 2 — MARKETING AUTHORISATION REQUIREMENTS →

Other provisions in CHAPTER 2 — MARKETING AUTHORISATION REQUIREMENTS

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

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

What to look at next

Regulation (EC) No 1394/2007, full textChapter navigation and full text, so you can read this section in contextEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearCHAPTER 2 — MARKETING AUTHORISATION REQUIREMENTS — read this in contextThe surrounding text of the act in order, so you can see what comes before and afterChapters and sections