Der Arzneimittelbegriff im deutschen, europäischen und US-amerikanischen Recht

The question whether a product is subject to the drug law’s stringent regulatory market access, distribution and advertising regulations hinges on the interpretation of the controversial regulatory drug definition. A particular point of debate is the importance and meaning of the term ‘pharmacological action’, which has been taken over from medical device law into the drug definition.
This work is the first to analyse the drug definition by way of legal comparison to US and FDA law and focuses on the borderline with the medical devices definition. It shows that the drug and device definitions of US law have significantly shaped European law – and, thus, indirectly German drug law, too. On this basis, the work compares the FDA’s policy on classifying products as drugs or devices with the case law of the ECJ and the German courts as well as with the German legal authors, and offers its own classification proposal.