INSTRUÇÃO NORMATIVA IN Nº 100, DE 23 DE Agosto DE 2021
| Data | 23 Agosto 2021 |
| Páginas | 199-199 |
| Data de publicação | 25 Agosto 2021 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Diretoria Colegiada |
| Seção | DO1 |
INSTRUÇÃO NORMATIVA IN Nº 100, DE 23 DE Agosto DE 2021
Estabelece os medicamentos sujeitos ao Sistema Nacional de Controle de Medicamentos (SNCM) e os prazos para serialização e para início da comunicação de registros de instâncias de eventos.
A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso das atribuições que lhe confere o art. 15, III e IV, aliado ao art. 7º, III e IV da Lei nº 9.782, de 26 de janeiro de 1999, e ao art. 53, VII, §§ 1º e 3º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 255, de 10 de dezembro de 2018, resolve adotar a seguinte Instrução Normativa, conforme deliberado em reunião realizada em 20 de agosto de 2021, e eu, Diretor-Presidente, determino a sua publicação.
Art. 1º Esta Instrução Normativa estabelece os medicamentos sujeitos ao Sistema Nacional de Controle de Medicamentos e os prazos para serialização e para início da comunicação de registros de instâncias de eventos, em cumprimento ao disposto no art. 2º da Resolução de Diretoria Colegiada - RDC nº 157, de 11 de maio de 2017, alterada pela Resolução de Diretoria Colegiada - RDC nº 319, de 12 de novembro de 2019.
Art. 2º Esta Instrução Normativa se aplica a todos os membros da cadeia de movimentação de medicamentos.
Parágrafo único. É facultado aos serviços de saúde geridos pelo Sistema Único de Saúde - SUS, às clínicas e aos consultórios privados o cumprimento das obrigações dispostas nesta Instrução Normativa.
Art. 3º O detentor de registro deve registrar e atualizar no SNCM as informações relativas:
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