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THE SUPREME DECREE IS PUBLISHED THAT "AMENDS THE REGULATION FOR THE REGISTRATION, CONTROL AND SANITARY SURVEILLANCE OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND SANITARY PRODUCTS" AND "APPROVES THE MANUAL OF GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS"

Mediante Decreto Supremo N° 021-2018-SA publicado el 22 de agosto de 2018 en el Diario Oficial “El Peruano” se dispuso:
​
Modificación del Anexo N° 01 del Decreto Supremo N°016-2011-SA (en los Numerales 41, 71 y 100).
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Aprobación del Manual de Buenas Prácticas de Manufactura de Productos Farmacéuticos.
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Asimismo el citado documento menciona que la entrada en vigencia del nuevo Manual de Buenas Prácticas de Manufactura de Productos Farmacéuticos es en el plazo de un (1) año contado a partir del día siguiente de su publicación en el Diario Oficial “El Peruano”. Sin embargo, las disposiciones contenidas en los subnumerales 6.34 y 29.23 entran en vigencia a los dos (2) años y a los cuatro (4) años, respectivamente. Mientras que lo señalado en los subnumerales 16.8, 16.9, 16.10 y 28.7 del precitado Manual entran en vigencia a los cinco (5) años.
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Fuente: Diario Oficial «El Peruano»

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