In the EU, a regulatory network consisting of the competent authorities in Member States, the European Commission and the European Medicines Agency (in GVP referred to as “the Agency”) is responsible for granting marketing authorisations and supervising medicinal products, including the conduct of pharmacovigilance. The Agency has a core role in coordinating these activities for the network. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp