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H del Punto 9.1:\nDonde dice:\n1. Para medicamentos Biol\u00f3gicos de 1\u00b0 y 2\u00b0 Generaci\u00f3n, Hemoderivados-Inmunosupresores-Oncol\u00f3gicos y para F\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares\n1.3) Para productos Oncol\u00f3gicos Orales e Inyectables (Busulfan 60 mg y Melfalan 50 mg)\nRegistro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia.\nEn ese sentido, la especialidad medicinal ofertada debe encontrarse registrada en:\n\u2022\tFDA o EMA\n\u2022\tLos indicados de alta vigilancia en el Art 11 de la Ley 3283/2007.\n\u2022\tPa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA).\n\nDebe decir:\n1. 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