Abstract
Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.
Keywords: Advanced therapy medicinal product, hospital exemption, regulation.
Current Stem Cell Research & Therapy
Title:Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States
Volume: 12 Issue: 1
Author(s): Tatjana Ivaskiene, Mykolas Mauricas and Justinas Ivaska
Affiliation:
Keywords: Advanced therapy medicinal product, hospital exemption, regulation.
Abstract: Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.
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Cite this article as:
Ivaskiene Tatjana, Mauricas Mykolas and Ivaska Justinas, Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States, Current Stem Cell Research & Therapy 2017; 12 (1) . https://dx.doi.org/10.2174/1574888X11666160714114854
DOI https://dx.doi.org/10.2174/1574888X11666160714114854 |
Print ISSN 1574-888X |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3946 |
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