This booklet explains how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network—a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA)—works to ensure that patients in the
EU have access to high-quality, effective and safe medicines.

 

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