Synthetic phosphoethanolamine law in Brazil

Detalhes bibliográficos
Autor(a) principal: Costa, Luana Dias
Data de Publicação: 2018
Outros Autores: Alves, Sandra Mara Campos
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468
Resumo: Objective: The objective was to analyze the context in which the aforementioned law was proposed and approved, in light of Brazilian legislation. Methodology: This was a descriptive-analytical study, considering that a theoretical review of the information available on the House Bill PL 4.639 / 2016, Federal Senate PLC No. 3/2016 and the Law of Phosphoethanolamine, Law 13,269, of April 13, 2016, in addition to the normative review of the attributions and competencies of Brazilian Health Surveillance Agency. Results: It is clear that a whole legal framework has been replaced by ordinary legislation with concrete effects. Conclusions: In the case in question, Brazilian Health Surveillance Agency performance was disregarded, since it is up to the Agency to carry out all the tests and subsequently release the product for consumption.
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spelling Synthetic phosphoethanolamine law in BrazilLei da fosfoetanolamina sintética no BrasilBrazilian Health Surveillance AgencyGovernment RegulationJudiciaryAgência Nacional de Vigilância SanitáriaRegulamentação GovernamentalPoder JudiciárioObjective: The objective was to analyze the context in which the aforementioned law was proposed and approved, in light of Brazilian legislation. Methodology: This was a descriptive-analytical study, considering that a theoretical review of the information available on the House Bill PL 4.639 / 2016, Federal Senate PLC No. 3/2016 and the Law of Phosphoethanolamine, Law 13,269, of April 13, 2016, in addition to the normative review of the attributions and competencies of Brazilian Health Surveillance Agency. Results: It is clear that a whole legal framework has been replaced by ordinary legislation with concrete effects. Conclusions: In the case in question, Brazilian Health Surveillance Agency performance was disregarded, since it is up to the Agency to carry out all the tests and subsequently release the product for consumption.Objetivo: O objetivo foi analisar o contexto em que foi proposto e aprovado o diploma legal que autorizou o fornecimento da fosfoetanolamina sintética à luz da legislação brasileira. Metodologia: Tratou-se de um estudo descritivo-analítico, considerando que foi feita uma revisão teórica das informações disponíveis sobre o projeto de Lei da Câmara PL nº 4.639/2016, no Senado Federal PLC nº 3/2016 e da Lei da Fosfoetanolamina, Lei nº 13.269, de 13 de abril de 2016, além da revisão normativa das atribuições e competências da Agência Nacional de Vigilância Sanitária. Resultados: Ocorreu uma substituição de todo o arcabouço jurídico por legislação ordinária de efeitos concretos. Conclusão: A atuação da Agência Nacional de Vigilância Sanitária foi desconsiderada, já que cabe à agência realizar todos os testes e, posteriormente, liberar o medicamento para o consumo.Fundação Oswaldo Cruz Brasília2018-04-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documenthttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/46810.17566/ciads.v7i1.468Iberoamerican Journal of Health Law; Vol. 7 No. 1 (2018): (JAN/MAR.2018); 215-228Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 7 Núm. 1 (2018): (JAN/MAR.2018); 215-228Cadernos Ibero-Americanos de Direito Sanitário; v. 7 n. 1 (2018): (JAN/MAR.2018); 215-2282358-18242317-839610.17566/ciads.v7i1reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468/526https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468/68210.17566/ciads.v7i1.468.s108Copyright (c) 2018 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIOinfo:eu-repo/semantics/openAccessCosta, Luana DiasAlves, Sandra Mara Campos2020-03-24T20:34:36Zoai:ojs.cadernos.prodisa.fiocruz.br:article/468Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2020-03-24T20:34:36Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Synthetic phosphoethanolamine law in Brazil
Lei da fosfoetanolamina sintética no Brasil
title Synthetic phosphoethanolamine law in Brazil
spellingShingle Synthetic phosphoethanolamine law in Brazil
Costa, Luana Dias
Brazilian Health Surveillance Agency
Government Regulation
Judiciary
Agência Nacional de Vigilância Sanitária
Regulamentação Governamental
Poder Judiciário
title_short Synthetic phosphoethanolamine law in Brazil
title_full Synthetic phosphoethanolamine law in Brazil
title_fullStr Synthetic phosphoethanolamine law in Brazil
title_full_unstemmed Synthetic phosphoethanolamine law in Brazil
title_sort Synthetic phosphoethanolamine law in Brazil
author Costa, Luana Dias
author_facet Costa, Luana Dias
Alves, Sandra Mara Campos
author_role author
author2 Alves, Sandra Mara Campos
author2_role author
dc.contributor.author.fl_str_mv Costa, Luana Dias
Alves, Sandra Mara Campos
dc.subject.por.fl_str_mv Brazilian Health Surveillance Agency
Government Regulation
Judiciary
Agência Nacional de Vigilância Sanitária
Regulamentação Governamental
Poder Judiciário
topic Brazilian Health Surveillance Agency
Government Regulation
Judiciary
Agência Nacional de Vigilância Sanitária
Regulamentação Governamental
Poder Judiciário
description Objective: The objective was to analyze the context in which the aforementioned law was proposed and approved, in light of Brazilian legislation. Methodology: This was a descriptive-analytical study, considering that a theoretical review of the information available on the House Bill PL 4.639 / 2016, Federal Senate PLC No. 3/2016 and the Law of Phosphoethanolamine, Law 13,269, of April 13, 2016, in addition to the normative review of the attributions and competencies of Brazilian Health Surveillance Agency. Results: It is clear that a whole legal framework has been replaced by ordinary legislation with concrete effects. Conclusions: In the case in question, Brazilian Health Surveillance Agency performance was disregarded, since it is up to the Agency to carry out all the tests and subsequently release the product for consumption.
publishDate 2018
dc.date.none.fl_str_mv 2018-04-02
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468
10.17566/ciads.v7i1.468
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468
identifier_str_mv 10.17566/ciads.v7i1.468
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468/526
https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/468/682
10.17566/ciads.v7i1.468.s108
dc.rights.driver.fl_str_mv Copyright (c) 2018 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2018 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/vnd.openxmlformats-officedocument.wordprocessingml.document
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 7 No. 1 (2018): (JAN/MAR.2018); 215-228
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 7 Núm. 1 (2018): (JAN/MAR.2018); 215-228
Cadernos Ibero-Americanos de Direito Sanitário; v. 7 n. 1 (2018): (JAN/MAR.2018); 215-228
2358-1824
2317-8396
10.17566/ciads.v7i1
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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