Anvisa publica nota técnica sobre lubrificantes e lágrimas artificiais

Publicado 26/03/2015 

A Anvisa publicou a Nota Técnica nº 55/2015/GGMED/ANVISA, que trata do reenquadramento de lágrimas artificiais e lubrificantes oculares como medicamentos específicos e traz orientações importantes ao setor regulado, elucidando dúvidas acerca da nova RDC 05/2015 e documentos necessários ao registro destes produtos.

Atualmente, a legislação define como lágrimas artificias e lubrificantes oftálmicos aqueles produtos que contêm emolientes (geralmente polímeros solúveis em água, como derivados de cellulose, dextrano 70, gelatina, poliois, álcool polivinílico ou povidona) e são aplicados topicamente no olho para proteger e lubrificar a superfície mucosa, aliviando a irritação, ardor e secura dos olhos.

Os produtos oftálmicos contendo associações entre emolientes e substâncias farmacologicamente ativas ou substâncias farmacologicamente ativas isoladas permanecem enquadrados em suas categorias atuais, não sendo tratados pela nota técnica.

Os medicamentos que tiveram o registro solicitado antes da publicação da RDC 05/2015, com enquadramento distinto da classe de medicamentos específicos, e que ainda não foram avaliados pela Anvisa, serão reenquadrados e avaliados como medicamentos específicos. A documentação faltante será solicitada por meio de notificação de exigência.

Já os medicamentos registrados como novos, similares ou genéricos, passam a ser enquadrados como medicamentos específicos a partir da publicação da RDC 05/2015. Desse modo, a próxima petição a ser realizada junto a Anvisa – alteração pós-registro, renovação, HMP – deverá ser realizada com enquadramento como “ESPECÍFICO”.

No caso dos medicamentos que tiveram o registro solicitado antes da publicação da RDC 05/2015 com outro enquadramento que não na classe de medicamentos específicos, e que estão em análise, a análise da petição será transferida para a Coordenação de Medicamentos Específicos, Notificados e Gases Medicinais (COGEN) e, se necessário, será emitida uma nova exigência para que a empresa apresente os documentos faltantes. O assunto da petição será atualizado e a decisão da solicitação de registro já será publicada como referente ao registro de medicamento específico.

Fonte: Anvisa

Foto: Feepik

 



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