The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders' concerns

Author:

Cuende Natividad,Boniface Christelle,Bravery Christopher,Forte Miguel,Giordano Rosaria,Hildebrandt Martin,Izeta Ander,Dominici Massimo

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference21 articles.

1. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products. Off J Eur Union 2009(September 15);L 243:3–12.

2. 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. Off J Eur Union 2007(October 12);L 324:121–37.

3. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Off J Eur Commun 2001(November 28);L 311:67–128.

4. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off J Eur Union 2004(April 30);L 136:1–33.

5. Hospital exemption for ATMPs (implementation of Art 28(2) of Regulation 1394/2007): update on feedback received by the Commission. Pharmaceutical Committee. 22 October 2012. PHARM 608,  [accessed 11.08.2014].

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