A set of guidelines for the conduct of pharmacovigilance in the European Union (EU), drawn up based on Article 108a(a) of Directive 2001/83/EC, by the European Medicines Agency in cooperation with

competent authorities in Member States and interested parties, and applying to marketing authorisation holders in the EU, the Agency and competent authorities in the Member States. GVP Annex I - Definitions (Rev 5)