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Good PharmacoVigilance Practices (GVP) for the European Union
Good PharmacoVigilance Practices (GVP) for the European Union
A set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based on Article 108a of Directive 2001/83/EC, by the European Medicines Agency in cooperation with competent authorities in the Member States and interested parties, and applying to marketing authorization holders in the EU, the Agency and competent authorities in the Member States.