Der Unionsvollzug des Europäischen Arzneimittelrechts

The EU pharmaceutical law is currently undergoing one of the most fundamental reform processes in its more than fifty-years old history. In particular, essential issues of the laws governing the marketing authorisation procedures implemented at the Union level are also affected. This work takes a comprehensive and decisive look at the centralised marketing authorisation procedures for medicinal products for human use in the EU, including pre-marketing and post-marketing authorisations, as well as national marketing authorisation procedures, insofar as they lead to a referral to the EU institutions. It addresses practitioners providing for them all legally relevant problems and suggestions for solutions, as well as the actors and stakeholders involved in the legislative procedure amending the EU medicinal products law.