RESOLUÇÃO-RE Nº 722, DE 3 DE MARÇO DE 2023
| Link to Original Source | http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=06/03/2023&jornal=515&pagina=253 |
| Data de publicação | 06 Março 2023 |
| Data | 03 Março 2023 |
| Páginas | 253-253 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO-RE Nº 722, DE 3 DE MARÇO DE 2023
A Gerente-Geral de Inspeção e Fiscalização Sanitária, no uso das atribuições que lhe confere o art. 140, aliado ao art. 203, I, § 1º do Regimento Interno aprovado pela Resolução da Diretoria Colegiada - RDC nº 585, de 10 de dezembro de 2021; e
considerando a necessidade de inclusão na certificação de boas práticas de fabricação, prevista no Art. 11 da RDC nº 497, de 20 de maio de 2021, resolve:
Art. 1º Incluir o insumo farmacêutico ativo biológico rituximabe na certificação da empresa Amgen Singapore Manufacturing Pte. Ltd (Código único: A.001246), solicitada pela empresa Amgen Biotecnologia do Brasil Ltda, CNPJ: 18.774.815/0001-93, publicada pela Resolução - RE nº 846, de 17 de março de 2022, publicada no Diário Oficial da União nº 54, de 21 de março de 2022, Seção 1, página 208, conforme expedientes nº 3445517/21-5 e 5044456/22-5.
Art. 2º Incluir o insumo farmacêutico ativo biológico crovalimabe na certificação da empresa Roche Diagnostics GmbH (Código único: A.000530), solicitada pela empresa Produtos Roche Químicos e Farmacêuticos S.A., CNPJ 33.009.945/0001-23, publicada pela Resolução - RE nº 3.295, de 5 de outubro de 2022, publicada no Diário Oficial da União nº 193, de 10 de outubro de 2022, Seção 1, página 104, conforme expedientes nº 0696071/22-3 e 5069754/22-0.
Art. 3º Incluir o insumo farmacêutico ativo biológico...
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