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New law strengthens EU pharmacovigilance system

This article was originally published in Scrip

Executive Summary

Member state ministers have adopted new legislation intended to improve the detection and reporting of adverse drug reactions in the EU. The legislation, which is the first of the three strands of the "pharmaceutical package" to be approved, will things set up a new pharmacovigilance committee at the European Medicines Agency, impose new obligations on industry and change the way that the side-effects of medicines are reported.






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