LEI Nº 14.187, DE 15 DE JULHO DE 2021
Data de publicação | 16 Julho 2021 |
Páginas | 1-1 |
Data | 15 Julho 2021 |
Órgão | Atos do Poder Legislativo |
Seção | DO1 |
LEI Nº 14.187, DE 15 DE JULHO DE 2021
Dispõe sobre a autorização para que estruturas industriais destinadas à fabricação de vacinas de uso veterinário sejam utilizadas na produção de insumos farmacêuticos ativos (IFA) e vacinas contra a covid-19 no Brasil.
O P R E S I D E N T E D A R E P Ú B L I C A
Faço saber que o Congresso Nacional decreta e eu sanciono a seguinte Lei:
Art. 1º Os estabelecimentos que fabricam vacinas de uso veterinário em conformidade com o Decreto-Lei nº 467, de 13 de fevereiro de 1969, poderão, na forma do regulamento, ser autorizados a fabricar insumos farmacêuticos ativos (IFA) e vacinas contra a covid-19, desde que cumpram todas as normas sanitárias e as exigências de biossegurança próprias dos estabelecimentos destinados à produção de vacinas para uso humano.
§ 1º Todas as fases relacionadas à produção, ao envasamento, à etiquetagem, à embalagem e ao armazenamento de vacinas para uso humano deverão ser realizadas em dependências fisicamente separadas daquelas que, em uma mesma estrutura industrial, sejam utilizadas para a fabricação de produtos destinados a uso veterinário.
§ 2º Quando não houver ambientes separados para que o armazenamento seja...
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