Anvisa: Indústrias deverão informar com antecedência de um ano sobre a retirada de produtos do mercado

Da Redação
Os fabricantes de medicamentos terão que informar à Anvisa – com um ano de antecedência – a intenção de retirar do mercado produtos que possam levar a uma situação de desabastecimento. A medida foi aprovada pela Anvisa em reunião pública no último dia 25.

O objetivo da medida é permitir que as medidas necessárias sejam tomadas com antecedência para reduzir os impactos à população pela falta de um medicamento. Com isso, empresas que decidem interromper a produção de um medicamento, seja por motivos técnicos ou mercadológicos, deverão garantir o fornecimento regular do produto durante esse período.

A obrigatoriedade abrange, por exemplo, produtos que não têm substitutos no mercado nacional e cuja retirada pode deixar os pacientes sem o tratamento adequado. As situações de redução na fabricação ou importação também deverão ser informadas com antecedência de 12 meses.

Nos casos em que a retirada do mercado não represente risco de desabastecimento, o prazo continua sendo de seis meses. É o caso de medicamentos que possuem substitutos registrados e disponíveis no país.

A norma prevê também que os casos imprevistos que possam levar ao desabastecimento deverão ser informados à Anvisa em até 72 horas, a partir da constatação do problema.
Fonte: Assessoria de Imprensa da Anvisa



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