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Glossary Terms

ArzneimittelMarktNeuOrdnungsGesetz (German Law for Reforming the Market for Pharmaceuticals)

A German law, agreed in November 2010 and in force since 1 January 2011, which aims to reduce the exploding costs of drugs within the German health system budget. AMNOG obliges pharmaceutical companies to submit a dossier (in German), including the results of all conducted studies, to set out the benefit assessment of any newly authorised medicinal product. In particular, as justification for the price of a new drug, the benefit assessment has to prove that the new product provides benefits over and above those offered by an already available and appropriate comparator.

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