[关于高级治疗用医药产品的（欧盟）第1394/2007号法规：纳入国内法]
[Regulation (EC) No. 1394/2007 on advanced therapy medicinal products : Incorporation into national law].
作者信息
Dwenger A, Strassburger J, Schwerdtfeger W
机构信息
Bundesministerium für Gesundheit, Rochusstr. 1, 53123, Bonn.
出版信息
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):14-9. doi: 10.1007/s00103-009-0985-3.
Regulation (EC) No. 1394/2007 has created a new legal framework for advanced therapy medicinal products (gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products). The Regulation is directly applicable in the Member States of the European Union and, in principle, requires no incorporation into national law. However, the amendment of Directive 2001/83/EC, which results from Regulation (EC) No. 1394/2007, has created a need for incorporation into and amendment of the German Medicinal Products Act. This is one of the objectives of the 15th amendment of the German Medicinal Products Act. In particular, the definition "advanced therapy medicinal products" and the special provisions for advanced therapy medicinal products prepared on a non-routine basis, which are based on the special provisions contained in Art. 28 No. 2 of Regulation (EC) No. 1394/2007, are to be incorporated into the German Medicinal Products Act. These special provisions will be explained in detail.
（欧盟）第1394/2007号法规为先进治疗药品（基因治疗药品、体细胞治疗药品和组织工程产品）创建了一个新的法律框架。该法规在欧盟成员国直接适用，原则上无需纳入国内法。然而，（欧盟）第1394/2007号法规对2001/83/EC号指令的修订，使得有必要将其纳入德国药品法并进行修订。这是德国药品法第15次修订的目标之一。特别是，“先进治疗药品”的定义以及基于（欧盟）第1394/2007号法规第28条第2款中的特殊规定而制定的非常规制备的先进治疗药品的特殊规定，都将被纳入德国药品法。这些特殊规定将详细解释。
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