Good pharmacovigilance practices (GVP) for the European Union (EU-GVP)

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.

Iceland, Liechtenstein and Norway have so far, through the Agreement of the European Economic Area (EEA), adopted the complete Union acquis (i.e. the legislation at EU level, guidelines and judgements) on medicinal products, and are consequently parties to the EU procedures. Where in the EU-GVP reference is made to Member States of the EU, this should be read to include Norway, Iceland and Liechtenstein7 .