BRUSSELS PREPARES INDUSTRY FOR PHARMACOVIGILENCE REFORMS
March 1st, 2012
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.
ENDS
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.
ENDS
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