Pharmacovigilance serves to protect and improve the health of humans and animals. Its primary purpose is to detect, prevent and combat risks associated with medicines. In the EU, the pharmacovigilance process begins as early as the clinical development stage, and continues right through to authorisation and surveillance of medicines after their authorisation. The supreme authority in the EU when it comes to medicines is the European Commission, although operational tasks are performed by the European Medicines Agency (EMA).

Translated by the European Commission
Last update: 31 March 2022

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