RESOLUÇÃO DE DIRETORIA COLEGIADA - RDC Nº 400, DE 21 DE JULHO DE 2020
| Data de publicação | 23 Julho 2020 |
| Data | 21 Julho 2020 |
| Páginas | 87-87 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Diretoria Colegiada |
| Seção | DO1 |
RESOLUÇÃO DE DIRETORIA COLEGIADA - RDC Nº 400, DE 21 DE JULHO DE 2020
Define os critérios e os procedimentos extraordinários e temporários para a aplicação de excepcionalidades a requisitos específicos de rotulagem e bulas de medicamentos, em virtude da emergência de saúde pública internacional decorrente do novo Coronavírus.
A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso das competências que lhe conferem os arts. 7º, incisos III, e 15, incisos III e IV, da Lei nº 9.782, de 26 de janeiro de 1999, e considerando o disposto no art. 53, inciso V 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 21 de julho de 2020, e eu, Diretor-Presidente Substituto, determino a sua publicação:
CAPÍTULO I
DISPOSIÇÕES INICIAIS
Art. 1º Esta Resolução dispõe sobre os critérios e os procedimentos extraordinários e temporários para a aplicação de excepcionalidades a requisitos específicos de rotulagem e bulas de medicamentos, em virtude da emergência de saúde pública internacional decorrente do novo Coronavírus.
Parágrafo único. Entende-se por excepcionalidade a autorização para flexibilização do cumprimento de requisitos técnicos estabelecidos pela Anvisa por meio de suas resoluções.
Art. 2º Esta Resolução abrange os medicamentos regularizados na Anvisa.
CAPÍTULO II
DAS EXCEPCIONALIDADES
Art. 3º Para os fins desta Resolução, poderão constituir...
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