Enforcement of EU pharmaceutical: inspection cooperation from global to EU to national level

Pharmaceuticals are globally traded products and often the manufacturing takes place far away from the point of sale. The manufacturing process is regulated though global standards, as well as European and national law. How can such a multi-level level framework be enforced? This paper will examine the cooperative procedures that lie at the heart of the EU’s enforcement regime though inspections. Next to mapping the applicable procedures and cooperative inspection models, it will analyze if the composite nature of this enforcement strategy leads to problems of accountability.