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In 2008, the Federal Ministry of Health launched an action plan for the improvement of medication safety. The action plan includes measures to prevent medication errors. Implementation of the action plan is supported by national associations of all professional groups involved in the medication process as well as patient associations. The major importance of medication safety has been recognised not only by scientists and researchers but also by political decision-makers. More efforts are clearly needed to translate the findings gleaned from the action plans into binding regulations to secure their nationwide implementation and, in the process, the further material improvement of medication safety. Irrespective of any such regulations-which is for the legislator or regulator to take-the fact remains that the greatest contributions towards this goal must come not only from the medical and nursing professionals in their daily clinical practice but also, and even to a far greater extent than has been the case so far, from the patients themselves.

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.

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