COMUNICATO - Farmacovigilanza: nuove modalita' di segnalazione delle sospette reazioni avverse (17A08493)
In attuazione di quanto disposto dall'art. 45, comma 8 del decreto ministeriale 30 aprile 2015, recante «Procedure operative e soluzioni tecniche per un'efficace azione di farmacovigilanza adottate ai sensi del comma 344 dell'art. 1 della legge 24 dicembre 2012, n. 228 (Legge di stabilita' 2013)», si comunica che l'Agenzia europea dei medicinali (EMA) ha annunciato l'inizio delle funzionalita' della Banca dati Eudravigilance: http://www.ema.europa.eu/ema/index.jspcurl=pages/regulation/gen eral/general_content_000679.jsp L'Ema ha avviato il 22 novembre scorso la nuova versione di EudraVigilance (EV), la piattaforma europea finalizzata alla segnalazione delle sospette reazioni avverse, relative ai medicinali autorizzati o in fase di sperimentazione clinica nell'ambito dell'Unione europea. L'Agenzia italiana del farmaco ha, pertanto, aggiornato la propria Rete nazionale di farmacovigilanza (RNF), per renderla compatibile ai requisiti del nuovo sistema. A decorrere...
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