EU prepares industry for pharmacovigilance reforms

Published: 28-Mar-2012
Regulatory

Coming into force in July


The European Commission has released guidance for drug manufacturers about transitional arrangements for the new European Union (EU) pharmacovigilance legislation that comes into force in July.

The guidance advises on legal and practical questions affecting the shift from the old to the new regimes, including application renewals, pharmacovigilance system master files and risk management plans.

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