Zur Abgrenzung von Arzneimitteln und Medizinprodukten am Beispiel von Abführmittel-Produkten Zählen alle Abführmittel zu den Arzneimitteln oder einige zu den Medizinprodukten? Andrea B. Gall und Univ.-Prof. Dr. rer. nat. habil. Harald G. Schweim Lehrstuhl für „Drug Regulatory Affairs“ der RFW-Universität Bonn, Bonn Starting from the historical development of the legal basis for medical devices and the influences of the European Community to the German law of medical devices, the present situation of physical acting purgatives is discussed by means of current examples. Based on the national definitions in the AMG and MPG, the European regulations and the guideline MEDDEV 2.1/3 Rev. 2 a possible assignment of the named product group is presented. |
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pharmind 2007, Nr. 5, Seite 518
