Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic

Detalhes bibliográficos
Autor(a) principal: de Farmacoterapia, Revista Portuguesa
Data de Publicação: 2020
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://doi.org/10.25756/rpf.v12i1-2.244
Resumo: The European Commission, European Medicines Agency and the European medicines regulatory network have developed a question-and-answer document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document was first published in April 2020 and will be updated to address new questions and to adjust the content thereof to the evolution of the pandemic, having already been revised in May 2020. This section attempts to describe a brief summary of the document. The document can be consulted at: https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf.
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spelling Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 PandemicAviso aos Stakeholders: Perguntas e Respostas sobre as Expectativas Regulamentares para Medicamentos de Uso Humano Durante a Pandemia de COVID-19The European Commission, European Medicines Agency and the European medicines regulatory network have developed a question-and-answer document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document was first published in April 2020 and will be updated to address new questions and to adjust the content thereof to the evolution of the pandemic, having already been revised in May 2020. This section attempts to describe a brief summary of the document. The document can be consulted at: https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf.A Comissão Europeia, a Agência Europeia do Medicamento e a Rede Europeia de Regulamentação de Medicamentos desenvolveram um documento de perguntas e respostas para fornecer orientações aos stakeholders sobre as adaptações ao quadro regulamentar para enfrentar os desafios decorrentes da pandemia do COVID-19. O documento foi inicialmente publicado em abril de 2020 e será continuamente atualizado de modo a abordar novas perguntas e ajustar o seu conteúdo à evolução da pandemia, tendo já sido revisto em maio de 2020. A presente secção procura descrever um breve resumo do documento. O documento pode ser consultado na íntegra em: https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf.Formifarma2020-07-21info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://doi.org/10.25756/rpf.v12i1-2.244https://doi.org/10.25756/rpf.v12i1-2.244Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 12 No 1-2 (2020): Janeiro/Fevereiro/Março e Abril/Maio/Junho; 77-78Revista Portuguesa de Farmacoterapia; v. 12 n. 1-2 (2020): Janeiro/Fevereiro/Março e Abril/Maio/Junho; 77-782183-73411647-354Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttp://revista.farmacoterapia.pt/index.php/rpf/article/view/287http://revista.farmacoterapia.pt/index.php/rpf/article/view/287/260Direitos de Autor (c) 2020 Revista Portuguesa de Farmacoterapiahttp://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessde Farmacoterapia, Revista Portuguesa2023-09-01T04:34:57Zoai:ojs.farmacoterapia.pt:article/287Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T15:11:41.607555Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
Aviso aos Stakeholders: Perguntas e Respostas sobre as Expectativas Regulamentares para Medicamentos de Uso Humano Durante a Pandemia de COVID-19
title Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
spellingShingle Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
de Farmacoterapia, Revista Portuguesa
title_short Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
title_full Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
title_fullStr Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
title_full_unstemmed Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
title_sort Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic
author de Farmacoterapia, Revista Portuguesa
author_facet de Farmacoterapia, Revista Portuguesa
author_role author
dc.contributor.author.fl_str_mv de Farmacoterapia, Revista Portuguesa
description The European Commission, European Medicines Agency and the European medicines regulatory network have developed a question-and-answer document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document was first published in April 2020 and will be updated to address new questions and to adjust the content thereof to the evolution of the pandemic, having already been revised in May 2020. This section attempts to describe a brief summary of the document. The document can be consulted at: https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf.
publishDate 2020
dc.date.none.fl_str_mv 2020-07-21
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://doi.org/10.25756/rpf.v12i1-2.244
https://doi.org/10.25756/rpf.v12i1-2.244
url https://doi.org/10.25756/rpf.v12i1-2.244
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv http://revista.farmacoterapia.pt/index.php/rpf/article/view/287
http://revista.farmacoterapia.pt/index.php/rpf/article/view/287/260
dc.rights.driver.fl_str_mv Direitos de Autor (c) 2020 Revista Portuguesa de Farmacoterapia
http://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Direitos de Autor (c) 2020 Revista Portuguesa de Farmacoterapia
http://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Formifarma
publisher.none.fl_str_mv Formifarma
dc.source.none.fl_str_mv Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 12 No 1-2 (2020): Janeiro/Fevereiro/Março e Abril/Maio/Junho; 77-78
Revista Portuguesa de Farmacoterapia; v. 12 n. 1-2 (2020): Janeiro/Fevereiro/Março e Abril/Maio/Junho; 77-78
2183-7341
1647-354X
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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