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Redes Sociais

Saúde v6n3n

Anvisa publica novas regras para venda de medicamento sem receita médica 492e6h

Os critérios dizem respeito ao tempo mínimo de comercialização; perfil de segurança; indicação para tratamento de doenças não graves; indicação de uso por curto período; ser manejável pelo paciente; baixo potencial de risco em situações de mau uso ou abuso; e não apresentar potencial de dependência

Publicado há

9 anos

em

Os critérios a que um medicamento deve atender para ser classificado como isento de prescrição médica e possa ser vendido diretamente ao consumir, sem receita, foram publicados na edição desta quarta-feira (dia 3) do Diário Oficial da União. A Resolução da Diretoria Colegiada 98/2016, da Agência Nacional de Vigilância Sanitária (Anvisa), traz novas regras e fixa sete critérios para que o medicamento seja registrado como isento de prescrição.

Os critérios dizem respeito ao tempo mínimo de comercialização; perfil de segurança; indicação para tratamento de doenças não graves; indicação de uso por curto período; ser manejável pelo paciente; baixo potencial de risco em situações de mau uso ou abuso; e não apresentar potencial de dependência.

A proposta de texto para a resolução ou por consulta pública no ano ado e cidadãos, representantes da sociedade civil e do setor regulador, puderam enviar contribuições. O texto publicado hoje no Diário Oficial da União foi aprovado pela Anvisa em julho e substitui a resolução anterior (138/2003) que não previa a possibilidade de atualização da lista de medicamento isento de prescrição. De acordo com a Anvisa, isso impossibilitou que medicamentos que têm perfil de segurança e uso compatíveis com a venda sem prescrição fossem incorporados à categoria de venda.

A resolução traz ainda as orientações para que as farmacêuticas possam solicitar o enquadramento e reenquadramento de medicamentos na lista dos isentos de prescrição.

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