RESOLUÇÃO-RE Nº 707, DE 12 DE MARÇO DE 2020
Data de publicação | 16 Março 2020 |
Data | 12 Março 2020 |
Páginas | 79-79 |
Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Segunda Diretoria,Gerência-Geral de Medicamentos e Produtos Biológicos |
Seção | DO1 |
RESOLUÇÃO-RE Nº 707, DE 12 DE MARÇO DE 2020
O Gerente-Geral de Medicamentos e Produtos Biológicos, no uso das atribuições que lhe confere o art. 130, aliado ao art. 54, I, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 255, de 10 de dezembro de 2018, resolve:
Art. 1º Publicar a aprovação condicional das petições secundárias de medicamentos similares, genéricos e novos, sob os números de expedientes constantes no anexo desta Resolução, nos termos do art. 17-A, §§ 3º e 4º, da Lei nº 6.360, de 23 de setembro de 1976, alterada pelos arts. 2º e 4º da Lei n° 13.411, de 28 de dezembro de 2016, e arts. 4º, 7º e 16, da Resolução de Diretoria Colegiada - RDC nº 219, de 27 de fevereiro de 2018.
Art. 2º Este ato administrativo decorre do atendimento integral pelas empresas detentoras dos registros, ao disposto no art. 7º e seus incisos, da Resolução de Diretoria Colegiada - RDC nº 219, de 27 de fevereiro de 2018.
Art. 3º A aprovação condicional das petições secundárias objeto desta Resolução é restrita ao assunto protocolado, não resultando em manifestação diversa da peticionada, e considera estritamente a condição já registrada, não aprovando nenhuma alteração da condição registrada que possa estar informada nos documentos que instruem a petição secundária.
Art. 4º Esta Resolução entra em vigor na data de sua publicação.
GUSTAVO MENDES LIMA SANTOS
ANEXO
NOME DA EMPRESA
NOME DO MEDICAMENTO NÚMERO DO PROCESSO
EXPEDIENTE PETIÇÃO 2ª ASSUNTO DA PETIÇÃO 2ª
EXPEDIENTE PETIÇÃO CLONE ASSUNTO PETIÇÃO CLONE
(ASSUNTO PETIÇÃO...
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