DECRETO 23 marzo 2016 - Revoca dei presidi medico chirurgici contenenti principi attivi oggetto delle decisioni di non inclusione emanate ai sensi dell'articolo 9 del regolamento (UE) n. 528/2012. (16A02953)
IL DIRETTORE GENERALE dei dispositivi medici e del servizio farmaceutico Visto il regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio del 22 maggio 2012, relativo alla messa a disposizione sul mercato e all'uso dei biocidi;
Considerato che, ai sensi dell'articolo 9 del regolamento (UE) n. 528/2012, qualora non siano soddisfatte le condizioni di cui all'articolo 4, paragrafo 1, o, se applicabili, le condizioni di cui all'articolo 5, paragrafo 2, ovvero se le informazioni e i dati richiesti non sono stati forniti nel periodo previsto, la Commissione europea adotta una decisione di esecuzione secondo cui un principio attivo non e' approvato;
Visto il decreto del Presidente della Repubblica 6 ottobre 1998, n. 392 in materia di procedimenti di autorizzazione alla produzione e all'immissione in commercio di presidi medico chirurgici;
Visto, in particolare, l'articolo 89, paragrafo 2, lett. b) del regolamento (UE) n. 528/2012, in base al quale uno Stato membro puo' continuare ad applicare il regime o la prassi in esso vigenti in materia di messa a disposizione di biocidi sul mercato per un periodo massimo di 365 giorni dopo la data della decisione di non approvare un principio attivo;
Ritiene necessario specificare che decorsi 365 gg dalla data di entrata in vigore della...
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