Translation of pharmacovigilance (English-English)

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pharmacovigilance: the term 'pharmacovigilance' is meant to cover the collection of information on adverse drug reactions(ADRs),at pre-and post-marketing stage,the scientific evaluation of these ADR reports and the regulatory decisions which may have to be taken following their analysis.These regulatory decisions may include in extreme cases withdrawal or suspension of the marketing authorization,but,more often,a modification of the legal status of the drug and amendments or warnings in the summary of products characteristics,labelling and package leaflet
Category: Medicine

pharmacovigilance: charge
Category: The European Communities

Please see: encyclo.co.uk for more definitions

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