ANVISA publica lista de medicamentos similares intercambiáveis

anvisa

A partir da criação da Anvisa e da implantação da política dos medicamentos genéricos, foram estabelecidos importantes regulamentos sanitários. Esses novos regulamentos alcançaram não somente os medicamentos genéricos, mas também os medicamentos similares. Tal fato decorreu da necessidade de regulação do mercado farmacêutico brasileiro para aprimorar os critérios de garantia da qualidade, eficácia e segurança dos medicamentos, tanto daqueles que já se encontravam no mercado quanto dos que viessem a ser registrados na Anvisa.

Dentre outras, a Anvisa publicou em 2003 a Resolução da Diretoria Colegiada – RDC no 134/2003, que estabeleceu critérios para a adequação dos medicamentos similares já registrados e comercializados no Brasil. A referida RDC obrigou os detentores de registro de medicamentos similares a apresentarem estudos comparativos com o medicamento de referência tais como, equivalência farmacêutica, perfil de dissolução e bioequivalência/biodisponibilidade relativa (BD/BE), se aplicável ao fármaco e forma farmacêutica.

O objetivo destas determinações é a comprovação da equivalência terapêutica entre o medicamento similar registrado e o seu respectivo medicamento de referência. Em 2014, por meio da RDC 58/2014, que definiu as medidas a serem adotadas junto à Anvisa pelos titulares de registro de medicamentos para a intercambialidade de medicamentos similares com o medicamento de referência, ficou determinada a disponibilização no site da Agência da relação dos medicamentos similares indicando os medicamentos de referência com os quais são intercambiáveis para fins de consulta pela população por profissionais de saúde ou qualquer outro interessado. A lista será atualizada mensalmente, à medida que novos similares forem registrados e renovados com a análise dos estudos comparativos citados.

Todos os medicamentos similares intercambiáveis  constantes da lista também terão na bula do medicamento a  informação a respeito da intercambialidade, conforme determina a RDC 58/2014. Tal informação será apresentada por meio da frase: MEDICAMENTO SIMILAR EQUIVALENTE AO MEDICAMENTO DE REFERÊNCIA. A referida informação deve ser incluída  na seção da bula “Identificação do Medicamento”, logo abaixo da Denominação Comum Brasileira  (DCB) do(s) princípio(s) ativo(s) do medicamento, respeitando o modelo já existente de bula descrito no Anexo I da RDC 47/09.

Para essa inclusão, a empresa detentora de registro de medicamento similar intercambiável terá o prazo de 1 (um) ano a contar de sua inclusão na lista publicada no site da Anvisa. O peticionamento deverá ser feito por meio do assunto “10756 – SIMILAR – Notificação de alteração de texto de bula para adequação à intercambialidade” e deverá ser seguido o fluxo de peticionamento de bulas, de acordo com as orientações do Guia de Submissão Eletrônica de Texto de Bula.

Para acessar a lista, clique aqui!!!

Fonte: Assessoria de Imprensa da Anvisa



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