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EMA: Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with final definition annex revision 2

09.01.2014
New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a new set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they are adopted, replace the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.