DETERMINA 10 aprile 2014 - Rettifica della determina n. 242 del 10 marzo 2014, relativa al medicinale per uso umano «Voriconazolo Accord» (voriconazolo). (Determina n. 368/2014). (14A03241)
IL DIRETTORE GENERALE Vista la determinazione n. 242 del 10 marzo 2014 relativa al medicinale per uso umano «Voriconazolo Accord» (voriconazolo) pubblicata nella Gazzetta Ufficiale - serie generale - n. 73 del 28 marzo 2014;
Considerata la documentazione agli atti di questo ufficio;
Rettifica: 1. All'art. 1, relativo alla «Classificazione ai fini della rimborsabilita'», si intenda aggiunto: «La classificazione di cui alla presente determinazione ha efficacia, ai sensi dell'art. 11, comma 1, ultimo periodo, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, dal giorno successivo alla data di scadenza del brevetto o del certificato di protezione complementare, pubblicata dal Ministero dello sviluppo economico. Sino alla scadenza del termine di cui al precedente comma, il medicinale VORICONAZOLO ACCORD e' classificato, ai sensi dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, denominata classe C (nn).». 2. Dopo l'art. 3, relativo alle «Condizioni e modalita'...
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