What Commission Regulation (EC) No 1394/2007 of 13 November 2007 on Advanced Therapy Medicinal Products requires
This regulation requires manufacturers of advanced therapy medicinal products, including gene therapy, somatic cell therapy, and tissue-engineered products, to comply with the centralised authorisation procedure as outlined in Article 3. Citing Article 3 of Regulation 1394/2007, all such products must be authorised by the European Commission before being placed on the market.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32007R1394
SHA-256 integrity: b4acd866b2d7fe085d7372253f4878f3279d05d9a8da677a3769069938fce970
Primary Citations — 7 traced to source
- Regulation 1394/2007, Article 3 - Centralised authorisation procedure
- Regulation 1394/2007, Article 5 - Application for centralised authorisation
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