DECRETO 2 settembre 1998 - Divieto di utilizzo di derivati da placenta di origine umana per la produzione di medicinali ad uso umano
IL MINISTRO DELLA SANITA'
Visto il decreto legislativo 29 maggio 1991, n. 178, cosi' come modificato dal decreto legislativo 18 febbraio 1997, n. 44, e in particolare l'art. 25, comma 8; Visto il parere espresso dall'Istituto superiore di sanita' con il quale, in relazione all'importazione di materiale biologico, ha evidenziato l'accentuata difficolta' di applicazione delle procedure di idonea selezione dei donatori nella fase di raccolta del materiale biologico di partenza, quale la placenta di origine umana; Visto il parere espresso dal Consiglio superiore di sanita' nella seduta del 30 gennaio 1998 con il quale ha rivolto invito a formulare specifiche norme sull'utilizzo, a qualunque scopo terapeutico, di prodotti di derivazione biologica non regolamentati; Visto il parere espresso dalla Commissione unica del farmaco nella riunione del 24 febbraio 1998 con il quale ha formulato la proposta di emanare un provvedimento teso vietare l'utilizzo di derivati da placenta di origine umana nei prodotti ad uso umano; Considerato che l'efficacia terapeutica di medicinali derivati da detto materia le biologico non risulta confermata dalla letteratura scientifica internazionale; Considerato che l'efficacia terapeutica di medicinali derivati da detto materia le biologico non risulta confermata dalla letteratura scientifica internazionale; Considerato che esistono valide alternative terapeutiche con farmaci non derivati da placenta umana; Ravvisata l'esigenza di assicurare il beneficio terapeutico con medicinali rispondenti ai previsti requisiti di sicurezza e di qualita', applicati sia nei processi di produzione e di rimozione/inattivazione...
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