Anvisa suspende teste de rastreabilidade para medicamentos

Publicado 26/10/2015

A Anvisa publicou na última sexta-feira uma Resolução que suspende o teste de rastreabilidade que as indústrias teriam que fazer até o final deste ano. Segundo a Resolução da Diretoria Colegiada – RDC nº 54, de 10 de dezembro de 2013, as indústrias teriam que testar a rastreabilidade em três lotes de medicamentos em toda a cadeia, conforme reportagem sobre rastreabilidade publicada aqui.

Com a publicação da RDC n° 45 de 22 de outubro de 2015, essa obrigatoriedade fica suspensa, mas não define nova data para retomada do processo.

Segue resolução completa:






DOU de 23/10/2015 (nº 203, Seção 1, pág. 57)

Dispõe sobre a alteração da Resolução da Diretoria Colegiada – RDC nº 54, de 10 de dezembro de 2013, para suspensão do prazo de disponibilização de dados de rastreamento completo de 3 (três) lotes de medicamentos até as unidades de dispensação, pelas empresas detentoras de registro.

A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso da atribuição que lhe conferem os incisos III e IV, do art. 15, da Lei nº 9.782, de 26 de janeiro de 1999, o inciso V e §§ 1º e 3º do art. 58 do Regimento Interno aprovado nos termos do Anexo I Resolução da Diretoria Colegiada – RDC nº 29, de 21 de julho de 2015, publicada no D.O.U de 23 de julho de 2015, tendo em vista o disposto nos incisos III, do art. 2º, III e IV, do art. 7º da Lei nº 9.782, de 1999, e o Programa de Melhoria do Processo de Regulamentação da Agência, instituído por Portaria nº 422, de 16 de abril de 2008, em reunião realizada em 1º de outubro de 2015, adota a seguinte Resolução da Diretoria Colegiada e eu, Diretor-Presidente, determino a sua publicação.

Art. 1º – Fica suspensa a eficácia do inciso II do art. 23 da Resolução da Diretoria Colegiada – RDC nº 54, de 10 de dezembro de 2013, publicada no Diário Oficial da União nº 240, seção 1, de 11 de dezembro de 2013.

Art. 2º – Esta Resolução entra em vigor na data de sua publicação.




Fonte: Assessoria de Comunicação FEBRAFAR

Foto: GS1 Brasil

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