DECRETO 19 novembre 2003 - Modifica degli stampati di medicinali veterinari ad azione immunologica contenenti oli minerali
IL DIRETTORE GENERALE della sanita' veterinaria e degli alimenti
Visto il decreto legislativo 30 marzo 2001, n. 165; Visto il decreto del Presidente della Repubblica 28 marzo 2003, n. 129; Visto il decreto legislativo n. 119/1992 e successive modificazioni, in particolare l'art. 6, comma 2 e il capitolo VI-bis; Visto l'art 28 del Regolamento CEE 2309/93 del Consiglio che stabilisce le procedure comunitarie per l'autorizzazione e la vigilanza dei medicinali per uso umano e veterinario e che istituisce un'Agenzia europea di valutazione dei medicinali; Viste le linee guida della Commissione in materia di medicinali veterinari e farmacovigilanza veterinaria; Ritenuto a tutela della salute pubblica di dover provvedere a modificare gli stampati dei medicinali veterinari ad azione immunologica contenenti oli minerali; Decreta
Art. 1.
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E' fatto obbligo a tutte le aziende titolari di autorizzazione all'immissione in commercio di medicinali veterinari ad azione immunologica contenenti oli minerali di integrare gli stampati e il riassunto delle caratteristiche del prodotto secondo quanto indicato nell'allegato 1 che costituisce parte del presente decreto.
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Le modifiche di cui al comma 1, che costituiscono parte del decreto di autorizzazione rilasciato per ciascun medicinale veterinario...
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