The advanced therapy classification procedure

Author:

Voltz-Girolt C.,Celis P.,Boucaumont M.,D’Apote L.,Pinheiro M.-H.,Papaluca-Amati M.

Publisher

Springer Science and Business Media LLC

Subject

Public Health, Environmental and Occupational Health

Reference7 articles.

1. European Union (2003) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code related to medicinal products for human use. Official Journal of the European Union L159:46–94

2. Bock AK, Rodriguez-Cerezo E, Hüsing B et al (2005) Human tissue-engineered products: Potential socio-economic impacts of a new European regulatory framework for authorisation, supervision and vigilance. Synthesis report Eur 21838 EN, Institute for Prospective Technology Studies, Seville, Spain, pp 1–58

3. European Union (2007) Regulation (EC) No 1394/2007 of the European Parliament and Council of 13 November 2007 on Advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union, L324:121–137

4. Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) No 1394/2007

5. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

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