RESOLUÇÃO RE Nº 831, DE 24 DE Fevereiro DE 2021
| Páginas | 141-141 |
| Data de publicação | 01 Março 2021 |
| Data | 24 Fevereiro 2021 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO RE Nº 831, DE 24 DE Fevereiro DE 2021
A Gerente-Geral de Inspeção e Fiscalização Sanitária, no uso das atribuições que lhe confere o art. 171, aliado ao art. 54, I, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 255, de 10 de dezembro de 2018,
considerando o cumprimento dos requisitos de Boas Práticas de Fabricação preconizados em legislação vigente, para a área de Medicamentos, resolve:
Art. 1º Conceder à(s) empresa(s) constante(s) no anexo, a Certificação de Boas Práticas de Fabricação de Medicamentos.
Art. 2º A presente Certificação tem validade de 2 (dois) anos a partir da sua publicação.
Art. 3º Esta Resolução entra em vigor na data de sua publicação.
ANA CAROLINA MOREIRA MARINO ARAÚJO
ANEXO
Fabricante: GlaxoSmithKline Biologicals S.A
Endereço: Rue de l'Institut, 89, B-1330 Rixensart
País: Bélgica Código único: A.0271
Solicitante: Fundação Oswaldo Cruz CNPJ: 33.781.055/0001-35
Autorização de Funcionamento: 1.01.063-3 Expediente(s): 2687128/20-1
Certificado de Boas Práticas de Fabricação de Medicamentos:
Insumos farmacêuticos ativos biológicos: polissacarídeos capsulares de Streptococcus pneumoniae dos sorotipos 1, 4, 5, 6B, 7F, 9V, 14, 23F conjugados à proteína D (purificação e pré-formulação); polissacarídeos capsulares de Streptococcus pneumoniae do sorotipo 18C conjugado ao toxoide tetânico (purificação e pré-formulação); polissacarídeos capsulares de Streptococcus pneumoniae do sorotipo 19F conjugado ao toxoide diftérico (purificação e pré-formulação); toxoide diftérico (purificação)...
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