DECRETO 27 giugno 2003 - Modifica del decreto ministeriale 13 novembre 2001, recante disposizioni sulla modifica della composizione dei medicinali costituiti da vaccini monodose iniettabili contenenti mertiolato o altri composti organomercuriali come conservanti o come residui nel processo produttivo
IL MINISTRO DELLA SALUTE
Visto il decreto del Ministro della salute del 13 novembre 2001, recante disposizioni sulla modifica della composizione di medicinali costituiti da vaccini monodose iniettabili contenenti mertiolato o altri composti organomercuriali come conservanti o come residui nel processo produttivo; Considerato che il suddetto decreto si riferisce solo a vaccini autorizzati secondo procedura di registrazione nazionale; Visto il ´Position Statement EMEA/CPMP/1578/00ª dell'EMEA (Agenzia europea valutazione medicinali) del 29 giugno 2000 in cui il CPMP (Comitato europeo specialita' medicinali) stabilisce che la vaccinazione con i vaccini esistenti, compresi quelli contenenti tiomersale, continua ad offrire benefici alla popolazione generale ed infantile, e considera che i benefici delle vaccinazioni sono ampiamente superiori rispetto a rischi potenziali di esposizione a vaccini contenenti tiomersale (documento pubblicato sul sito internet ufficiale dell'EMEA
http://www.emea.eu.int/pdfs/human/press/pos/157800en.pdf); Visto il documento CPMP/BWP/2517/00 ´Points to Consider on the reduction, elimination or substitution of Thiomersal in Vaccinesª approvato dal CPMP il 26 aprile 2001, dove il Comitato conclude che non vi e' alcuna evidenza di rischio causata dal livello di esposizione da vaccini, e ritiene tuttavia opportuno promuovere in futuro la presenza di vaccini privi di tiomersale ed altri preservanti organomercuriali, particolarmente per i vaccini monodose (documento pubblicato sul sito internet ufficiale dell'EMEA
http://www.emea.eu.int/pdfs/human/bwp/251700en.pdf); Sentito il Consiglio superiore di sanita', sezione V, nella seduta del 17 giugno 2003; Considerato...
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