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Current Stem Cell Research & Therapy


ISSN (Print): 1574-888X
ISSN (Online): 2212-3946

Review Article

Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States

Author(s): Tatjana Ivaskiene, Mykolas Mauricas and Justinas Ivaska

Volume 12, Issue 1, 2017

Page: [45 - 51] Pages: 7

DOI: 10.2174/1574888X11666160714114854

open access plus


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.

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