EMA Prepares to Introduce New Pharmacovigilance Legislation
The new pharmacovigilance legislation will significantly increase the transparency of all pharmacovigilance activities of the Agency and the European Member States.
The European Medicines Agency, together with the European Member States and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995.
With the new legislation, any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority. This right already exists in some Member States. The Agency will cooperate with the Member States on providing information to patients on direct reporting during 2012.
The new pharmacovigilance legislation will significantly increase the transparency of all pharmacovigilance activities of the Agency and the European Membe
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