Decreto nº 3.718 de 03/01/2001. DA NOVA REDAÇÃO A DISPOSITIVOS DO ANEXO AO DECRETO 3.675, DE 28 DE NOVEMBRO DE 2000, QUE DISPÕE SOBRE MEDIDAS ESPECIAIS RELACIONADAS COM O REGISTRO DE MEDICAMENTOS GENERICOS, DE QUE TRATA O ARTIGO 4 DA LEI 9.787, DE 10 DE FEVEREIRO DE 1999.
DECRETO Nº 3.718, DE 3 DE JANEIRO DE 2001
Dá nova redação a dispositivos do Anexo ao Decreto nº 3.675, de 28 de novembro de 2000, que dispõe sobre medidas especiais relacionadas com o registro de medicamentos genéricos, de que trata o art. 4º da Lei nº 9.787, de 10 de fevereiro de 1999.
O PRESIDENTE DA REPÚBLICA, no uso da atribuição que lhe confere o art. 84, inciso IV, da Constituição, e tendo em vista o disposto no art. 4º da Lei nº 9.787, de 10 de fevereiro de 1999,
D E C R E T A:
Os dispositivos indicados do Anexo ao Decreto nº 3.675, de 28 de novembro de 2000, passam a vigorar com a seguinte redação:
"ANEXO
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III - Relatório Técnico
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Aspectos do Controle de Qualidade
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4. Caso o medicamento de referência utilizado nos ensaios não seja da mesma empresa do medicamento de referência nacional, ou de empresa licenciada desta, a empresa interessada no registro deverá apresentar, além do certificado de equivalência farmacêutica, o estudo comparativos dos perfis de dissolução, empregando os fatores f1 e f2 entre o medicamento genérico e a referência nacional, e os ensaios de correlação in vitro/in vivo, quando couber, ou justificativa de sua realização.
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