DECRETO 24 ottobre 2002 - Modifica degli stampati di specialita' medicinali contenenti "Frazione flavonoica purificata e micronizzata"
IL DIRIGENTE GENERALE del Dipartimento per la valutazione di medicinali e la farmacovigilanza Visto il decreto legislativo 3 febbraio 1993, n. 29 e successive modificazioni ed integrazioni; Visto il decreto del Presidente della Repubblica 7 dicembre 2000, n. 435 concernente il regolamento recante norme di organizzazione del Ministero della sanita'; Visto il decreto del Presidente della Repubblica 2 febbraio 1994, n. 196 concernente il regolamento per il riordinamento del Ministero della salute, come modificato dal decreto del Presidente della Repubblica 1 agosto 1996, n. 518
Visto il decreto ministeriale 27 dicembre 1996, n. 704, concernente il regolamento recante norme sull'individuazione degli uffici centrali e periferici di livello dirigenziale del Ministero della salute; Visto il decreto legislativo 9 maggio 1991, n. 178 e successive modificazioni ed integrazioni; Visto il decreto legislativo 30 dicembre 1992, n. 540, e successive modificazioni ed integrazioni; Visto il parere della Commissione unica del farmaco reso nella riunione del 10 ottobre 2002 con il quale si approvano le modifiche degli stampati relativi ai medicinali contenenti come principio attivo "Frazione flavonoica purificata e micronizzata"; Ritenuto a tutela della salute pubblica dover provvedere a modificare gli stampati delle specialita' a base di "Frazione flavonoica purificata e micronizzata"; Decreta
Art. 1.
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E' fatto obbligo a tutte le aziende titolari di autorizzazione all'immissione in commercio di specialita' medicinali, autorizzate con procedura di autorizzazione di tipo nazionale, contenenti come principio attivo "Frazione flavonoica purificata e micronizzata" di integrare gli stampati secondo quanto indicato nell'allegato 1 che costituisce parte del presente...
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