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La preparazione di un Investigational Medicinal Product Dossier (IMPD)

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Part of the Imaging & Formazione book series (IMAG)

Riassunto

Al fine di armonizzare le procedure di autorizzazione, l’EMA sollecita tutte le Autorità competenti (AC) degli Stati membri (SM) a utilizzare modulistiche per la presentazione e la valutazione della documentazione il più possibile analoghe a quelle usate per le procedure centralizzate. Il dossier del farmaco sperimentale (IMP, Investigational Medicinal Product), chiamato IMPD (Investigational Medicinal Product Dossier), ricalca infatti il CTD (Common Technical Document) utilizzato per la registrazione dei medicinali.

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