RESOLUÇÃO - RDC Nº 433, DE 5 DE NOVEMBRO DE 2020
| Data de publicação | 11 Novembro 2020 |
| Páginas | 73-73 |
| Data | 05 Novembro 2020 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Diretoria Colegiada |
| Seção | DO1 |
RESOLUÇÃO - RDC Nº 433, DE 5 DE NOVEMBRO DE 2020
Revoga a Resolução de Diretoria Colegiada - RDC nº 355, de 23 de março de 2020, e suas atualizações, e dispõe sobre o arquivamento temporário de petições de medicamentos e produtos biológicos, o uso de assinatura digital e a disponibilização de cópias de processos administrativos por meio eletrônico.
A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso das competências que lhe conferem os arts. 15, incisos III e IV, e 7º, inciso III, da Lei nº 9.782, de 26 de janeiro de 1999, e considerando o disposto no art. 53, inciso VI e §§ 1º e 3º, do Regimento Interno, aprovado pela Resolução de Diretoria Colegiada - RDC n° 255, de 10 de dezembro de 2018, resolve adotar a seguinte Resolução de Diretoria Colegiada, conforme deliberado em reunião realizada em 4 de novembro de 2020, e eu, Diretor-Presidente, determino a sua publicação:
Art. 1º Fica autorizada a apresentação à Agência Nacional de Vigilância Sanitária - ANVISA de solicitações pelas empresas de arquivamento temporário de petições em curso na Agência relacionadas a medicamentos e produtos biológicos nas seguintes hipóteses:
I - registros de insumos farmacêuticos ativos, medicamentos, produtos biológicos e produtos de cannabis;
II - mudanças pós-registro de medicamentos e produtos biológicos;
III - certificação de centros de bioequivalência;
IV - habilitação de centros de equivalência farmacêutica; e
V - anuência e modificação em ensaios clínicos de medicamentos e produtos biológicos.
§ 1º O arquivamento temporário de...
Para continuar a ler
PEÇA SUA AVALIAÇÃOSubscribers can access the reported version of this case.
You can sign up for a trial and make the most of our service including these benefits.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see a list of all the cited cases and legislation of a document.
You can sign up for a trial and make the most of our service including these benefits.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see a list of all the documents that have cited the case.
You can sign up for a trial and make the most of our service including these benefits.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Os assinantes podem ver as versões revisadas da legislação com emendas
You can sign up for a trial and make the most of our service including these benefits.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see any amendments made to the case.
You can sign up for a trial and make the most of our service including these benefits.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see a visualisation of a case and its relationships to other cases. An alternative to lists of cases, the Precedent Map makes it easier to establish which ones may be of most relevance to your research and prioritise further reading. You also get a useful overview of how the case was received.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see the list of results connected to your document through the topics and citations Vincent found.
You can sign up for a trial and make the most of our service including these benefits.
Por que se inscrever na vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.