Pelo projeto a Anvisa terá o prazo de até 72 horas após a submissão do pedido para liberar o medicamento, dispensada a autorização de qualquer outro órgão.
Foi aprovado nesta quarta-feira (6), durante sessão remota do Senado Federal, o Projeto de Lei 864/2020 que impõe à Agência Nacional de Vigilância Sanitária (Anvisa) o prazo máximo de 72 horas para autorizar a importação e distribuição de medicamentos e equipamentos liberados para uso no exterior contra a covid-19.
O senador Vanderlan Cardoso (PSD-GO) teve duas importantes emendas ao PL 864 acatadas pelo colegiado. Vanderlan explicou que as emendas tiveram caráter correcional, ou seja, foram emendas de correção de redação, mas essenciais para possibilitar a aprovação do Projeto e um possível veto presidencial por erros no texto.
“Tivemos acatadas as Emendas de No 11 e 15 que apenas promovem algumas correções necessárias ao texto. Dessa forma, conseguimos contribuir para que este importante projeto fosse aprovado de forma mais célere”, explicou.
Vanderlan enfatizou ainda que o PL 864 é extremamente oportuno já que pretende dispensar os produtos de saúde utilizados para o combate à covid-19 da etapa de registro. “Dessa forma, esses produtos poderão ser disponibilizados de maneira mais rápida aos serviços de saúde e, consequentemente, à população”, avaliou.
Projeto de Lei 864/2020 – De iniciativa do deputado Dr. Luiz Antonio Teixeira Jr. (PP-RJ), o PL transfere o poder de liberação dos medicamentos do Ministério da Saúde para a Anvisa, desde que os medicamentos ou insumos tenham sido registrados para distribuição comercial no exterior por um dos seguintes órgãos: Food and Drug Administration (FDA, nos Estados Unidos), European Medicines Agency (EMA, na União Europeia), Pharmaceuticals and Medical Devices Agency (PMDA, no Japão), ou National Medical Products Administration (NMPA, na China). Nesses casos, a Anvisa terá o prazo de até 72 horas após a submissão do pedido para liberar o medicamento, dispensada a autorização de qualquer outro órgão.
O projeto ainda obriga o médico que prescrever ou ministrar medicamento nessa condição a informar ao paciente ou ao seu representante legal que o produto ainda não tem aprovação ordinária da Anvisa e que foi liberado por ter sido registrado por autoridade sanitária estrangeira.
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