EMA Publishes New Union Procedure on the Management of Pharmacovigilance Inspection Findings

On 20 June 2014, the European Medicines Agency (hereafter “EMA”) published a new European Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products (“new EU Procedure”). The new EU Procedure came into effect on 1 June 2014.

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