PROVVEDIMENTO 5 febbraio 1999 - Approvazione dei requisiti della domanda e relativa documentazione da presentare ai fini dell'autorizzazione all'immissione in commercio ed alla variazione di autorizzazioni gia' concesse per i presidi medicochirurgici
IL DIRIGENTE GENERALE del Dipartimento per la valutazione dei medicinali e la farmacovigilanza Visto l'art. 189 del regio decreto 27 luglio 1934, n. 1265, recante "Approvazione del testo unico delle leggi sanitarie"; Visto il decreto del Presidente della Repubblica 6 ottobre 1998, n.
392, recante "Regolamento per la semplificazione del procedimento di autorizzazione alla produzione ed alla commercializzazione di presidi medicochirurgici" e, in particolare, l'art. 4, ai sensi del quale la domanda di autorizzazione alla modificazione delle condizioni in base alle quali e' stata rilasciata l'autorizzazione all'immissione in commercio, di modificazione di composizione o modificazione di campo di impiego o di modalita' di impiego deve contenere gli elementi indicati con apposito provvedimento del direttore del Dipartimento per la valutazione dei medicinali e la farmacovigilanza del Ministero da pubblicarsi nella Gazzetta Ufficiale della Repubblica italiana; Visto il decreto del Ministro della sanita' 6 marzo 1992, pubblicato nella Gazzetta Ufficiale n. 87 del 13 aprile 1992, relativo alla determinazione delle tariffe per i controlli e le analisi resi dall'Istituto superiore di sanita'; Visto il decreto del Ministro della sanita' 19 luglio 1993 relativo alla determinazione delle tariffe e dei diritti spettanti al Ministero della sanita', all'Istituto superiore di sanita' e...
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