• Mutual recognition and the ever-incomplete internal market for pharmaceuticals

This presentation will discuss the evolution of the mutual recognition of marketing authorizations for pharmaceuticals in the European Union. Pharmaceuticals are heavily regulated products and are subject to a marketing authorization requirement that can either be granted centrally on EU level for certain categories of innovative products or at national level for products that do not fall into the former category. It is in the context of these national procedures that mutual recognition plays a role. However, due to the political sensitive nature of pharmaceutical policy with its impact on human health, the national health care systems and certainly also matters of industrial policy, mutual recognition did not succeed on the basis of the principle alone, but required Europeanized procedures. This has led to the creation of sui generis mutual recognition procedural mechanisms and also to institutional innovations, which will be discussed in this presentation.