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The new EU pharmacovigilance rules: a disproportionate burden on industry?

This article was originally published in SRA

Executive Summary

At first glance, the European pharmacovigilance legislation adopted late last year (ie Directive 2010/84/EU1 and Regulation (EU) No 1235/20102) will undoubtedly bring about some welcome changes for marketing authorisation holders. However, there are also changes that may make the life of drug manufacturers more difficult – especially for those producing drugs that are often used off-label.

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