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43174l
A Agência Nacional de Vigilância Sanitária (Anvisa) irá aprofundar a discussão sobre a rastreabilidade de medicamentos. A Agência instituiu, nesta quinta-feira (3), um grupo de trabalho para avaliar a eficiência e efetividade das alternativas tecnológicas disponíveis. A medida foi tomada após uma recomendação do Conselho de Ministros da Câmara de Regulação do Mercado de Medicamentos (CMED), composto pelos ministros da Saúde, da Casa Civil, da Justiça, da Fazenda, e do Desenvolvimento, Indústria e Comércio Exterior.
O grupo de trabalho terá 60 dias para discutir as alternativas tecnológicas e harmonizar a implantação do sistema de rastreamento com os objetivos das políticas públicas de o a medicamentos. Além da Anvisa, o grupo terá representantes dos ministérios da Saúde, da Justiça e do Desenvolvimento, Indústria e Comércio Exterior.
O resultado do trabalho será avaliado pela Anvisa, que irá definir as ações a serem implementadas. Com a medida, a Instrução Normativa nº 11, de 29 de outubro de 2010, que dispôs sobre a tecnologia, produção, fornecimento e controle da distribuição das etiquetas de segurança, fica revogada. A Lei 11.903/09 continua em vigor e o trabalho que será realizado nos próximos 60 dias vai permitir o prazo de implantação do sistema de rastreabilidade, previsto para 2012.
Histórico
Para aprimorar continuamente os mecanismos de rastreabilidade e autenticidade de medicamentos no país, foi criado, em 2009, o Sistema Nacional de Controle de Medicamentos, por meio da Lei 11.903/09.
O sistema prevê o monitoramento de todo medicamento produzido, dispensado e vendido no Brasil, desde a fabricação até o consumo pela população. De acordo com a lei, o controle deverá ser realizado por meio de sistema de identificação, com o emprego de tecnologias de captura, armazenamento e transmissão eletrônica de dados. A implementação será feita no prazo gradual de três anos.
Imprensa/Anvisa