BRUSSELS PREPARES INDUSTRY FOR PHARMACOVIGILENCE REFORMS

BY KEITH NUTHALL

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