What Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004 requires
This regulation establishes a centralized authorization pathway and specific safety, quality, and efficacy requirements for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and tissue-engineered products, under Article 8 and Article 14. It applies to manufacturers, clinical developers, and healthcare providers involved in the production or administration of ATMPs in the EU.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and of the Council of the European Union · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007R1394
SHA-256 integrity: da269a3aca86bae2c160e7f911ac4171e3dc151c93e94ec360e5cd28f12fd1dd
Primary Citations — 5 traced to source
- Regulation (EC) No 1394/2007, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007R1394, Article 8, 2007
- Regulation (EC) No 1394/2007, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007R1394, Article 14, 2007
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