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                    <text>RESOLUCION Nº 354/94
RESUMEN: Plazo validez de la vacuna contra la Bacillus Anthracis.
BUENOS AIRES, 7 de abril de 1994
VISTO el resultado satisfactorio de los controles realizados sobre vacunas de Bacillus anthracis
en plazos posteriores a los doce meses de su elaboración, y
CONSIDERANDO:
Que las cepas de bacillus anthracis tipo Sterne (Cepa 34 F2 o su denominación similar CN 3742)
por sus características, permiten controles completos de laboratorio.
Que los métodos de control utilizados incluyen la estabilidad durante diez días a 37º C. lo que
permite predecir el comportamiento en el almacenaje posterior.
Que si bien la Resolución Nº 705 de fecha 19 de setiembre de 1991, establece un año como
período de validez de la actividad de las citadas vacunas, esta decisión se adoptó en su momento
debido a la inestabilidad que presentaban las mismas con anterioridad al año 1991.
Que la validez a nivel internacional es de 24 meses y en la reunión técnica mantenida entre las
autoridades nacionales de competencia y la industria privada, en oportunidad de poner en marcha
la citada reglamentación Nº 705/91, se expresó la posibilidad de la ampliación de la fecha de
vencimiento si controles posteriores daban resultados satisfactorios.
Que la experiencia adquirida permite asegurar que las vacunas anticarbunclosas producidas en
nuestro país aseguran una inmunidad suficiente durante 24 meses.
Que por ello es pertinente producir el acto técnico-administrativo que modifique lo establecido en
el artículo 18 de la Resolución Nº 705/91.
Que la Ley 23.899 (artículo 11 inciso o) acuerda facultades al suscripto para resolver sobre el
particular.
Por ello,
EL ADMINISTRADOR GENERAL DEL
SERVICIO NACIONAL DE SANIDAD ANIMAL
RESUELVE:
ARTICULO 1º- Modificar el artículo 18 de la Resolución Nº 705 de fecha 19 de setiembre de 1991,
el que quedará redactado de la siguiente forma:
“ARTICULO 18.- El plazo de validez de una serie o partida elaborada de vacunas
anticarbunclosas será de VEINTICUATRO (24) meses a partir de la fecha de su elaboración”.
ARTICULO 2º- Comuníquese, publíquese, dése a la Dirección Nacional del Registro Oficial y
archívese.
Fdo.: Dr. Jorge Néstor Amaya (Subadministrador)
RESOLUCION Nº 354/94

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