Non-interchangeable similar medicines: what now?

Authors

  • PATRICIA HELENA CASTRO NUNES

Keywords:

MEDICAMENTOS SIMILARES NO INTERCAMBIABLES: ¿Y AHORA QUÉ?

Abstract

A Lei 6.360, de 23 de setembro de 1976, dispõe sobre a vigilância sanitária a que ficam sujeitos os medicamentos e determina, em seu artigo 12, que estes produtos não podem ser industrializados, expostos à venda ou entregues ao consumo sem registro no Ministério da Saúde. a Desde 1999, com a publicação da Lei 9.782 de 26 de janeiro de 1999 3, o órgão responsável pela concessão deste registro é a Agência Nacional de Vigilância Sanitária (ANVISA). Existem diversas categorias para o registro de medicamentos na ANVISA. Elas objetivam possibilitar que as empresas comprovem a qualidade, a eficácia e a segurança de seus produtos, nos termos da Lei 6.360/76, Art. 16, II e III1, através do cumprimento de exigências compatíveis com o grau de risco que eles oferecem e com as propriedades específicas de seus fármacos, excipientes e formas farmacêuticas.

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Published

2019-03-11

How to Cite

1.
NUNES PHC. Non-interchangeable similar medicines: what now?. Rev Bras Farm Hosp Serv Saude [Internet]. 2019Mar.11 [cited 2024Jul.16];6(2). Available from: https://rbfhss.org.br/sbrafh/article/view/221

Issue

Vol. 6 No. 2 (2015): Apr-Jun

Section

ARTIGOS PUBLICADOS

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