RESOLUÇÃO RE Nº 2.008, DE 19 DE Maio DE 2021
| Data de publicação | 20 Maio 2021 |
| Data | 19 Maio 2021 |
| Páginas | 214-214 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária,Coordenação de Autorização de Funcionamento de Empresas |
| Seção | DO1 |
RESOLUÇÃO RE Nº 2.008, DE 19 DE Maio DE 2021
O Coordenador de Autorização de Funcionamento de Empresas, no uso das atribuições que lhe confere o art. 173-B, 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. Indeferir o Pedido de Autorização Especial para Empresas de Medicamentos e Insumos Farmacêuticos, constantes no anexo desta Resolução, de acordo com a Portaria nº. 344, de 12 de maio de 1998 e suas atualizações, observando-se as proibições e restrições estabelecidas.
Art. 2º Esta Resolução entra em vigor na data de sua publicação.
DANIEL MARCOS PEREIRA DOURADO
ANEXO
FARMACIA VITARTIS EIRELI - ME / 23.774.322/0001-93
25351.400670/2021-14 /
705 - AE - CONCESSÃO - FARMÁCIA DE MANIPULAÇÃO / 1643085219
MOTIVO DO INDEFERIMENTO:
Não apresentação da declaração assinada do Anexo I e II da RDC 275/2019, contrariando o Art. 11 da RDC nº 275/2019 e Art. 3º da RDC nº 25/2011.
--------------------------------------
DC MEDIC DISTRIBUIDORA LTDA / 39.718.543/0001-84
25351.211076/2021-42 /
761 - AE - CONCESSÃO - MEDICAMENTOS E INSUMOS FARMACÊUTICOS - ARMAZENADORA DO PRODUTO SUJEITO A CONTROLE ESPECIAL / 1068209216
MOTIVO DO INDEFERIMENTO:
Não apresentação do relatório de inspeção ou documento equivalente que ateste o cumprimento dos requisitos técnicos para as atividades e classes pleiteadas, emitidos pela autoridade sanitária local competente; conforme disposto nos artigos 15 e 18 da RDC nº 16/2014. Conforme o estabelecido pelo artigo 51 da Lei nº 6360/76...
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