DETERMINA 24 ottobre 2014 - Modifica del regime di fornitura del medicinale per uso umano «Domperidone Germed (domperidone)». (Determina n. 1214/2014). (14A08610)
IL DIRETTORE GENERALE Visto l'art. 48 del decreto legge 30 settembre 2003 n. 269, convertito nella legge 24 novembre 2003, n. 326, che istituisce l'Agenzia italiana del farmaco, e successive modifiche ed integrazioni;
Visto il decreto del Ministro della salute di concerto con i Ministri della funzione pubblica e dell'economia e finanze in data 20 settembre 2004, n. 245 recante norme sull'organizzazione ed il funzionamento dell'Agenzia italiana del farmaco, a norma del comma 13 dell'art. 48 sopra citato come modificato dal decreto n. 53 del Ministro della salute, di concerto con i Ministri per la pubblica amministrazione e la semplificazione e dell'economia e delle finanze del 29 marzo 2012;
Visto il decreto del Ministro della salute dell'8 novembre 2011, registrato dall'Ufficio centrale del bilancio al registro «Visti Semplici», foglio n. 1282, in data 14 novembre 2011, con cui e' stato nominato Direttore generale dell'Agenzia italiana del farmaco il prof. Luca Pani, a decorrere dal 16 novembre 2011;
Vista la decisione di esecuzione della Commissione europea del 14 luglio 2014 n. C(2014) 5113, riguardante le autorizzazioni all'immissione in commercio dei medicinali per uso umano contenenti la sostanza attiva «domperidone»;
Visto il verbale n. 27 della Commissione tecnica scientifica della seduta del 21-23 luglio 2014, che ha espresso parere favorevole alla riclassificazione della sola formulazione «sospensione orale» in RNRL, cioe' prescrizione da rinnovarsi volta per volta rilasciata da...
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