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New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.

This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.