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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