The EU Pharmacovigilance System
This chapter introduces pharmacovigilance in the European Union (EU); due to the multi-level nature of the EU, pharmacovigilance is described both at the European and the national level. Both levels are linked through multiple inter-institutional relations and, in combination, the European and national levels make up the EU’s pharmacovigilance system.
KeywordsEuropean Union Member State Medicinal Product Adverse Drug Reaction Reporting European Parliament
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