Brazil Local Networking Group

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  • 1.  RDC 185/2001 updating -Public consultation status

    Posted 10-Sep-2020 13:54
    Dear Brazil Community

    I am looking for the latest news on the upcoming update regarding the RDC 185/2001. Do you know if there is an expected date for the publication?

    All your comments are appreciated.

    Regards,



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    COA
    RA Specialist
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  • 2.  RE: RDC 185/2001 updating -Public consultation status

    Posted 16-Sep-2020 07:34
    Hi Carolina, how are you?

    According to ANVISA's regulatory agenda, RDC 185's update is expected to be published during 4Q/2020 (oct-dec).

    Hope that helps :)

    Best regards,

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    Bruno Oliveira MSc, IRCA
    Regulatory Intelligence Consultant
    São Carlos
    Brazil
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  • 3.  RE: RDC 185/2001 updating -Public consultation status

    Posted 16-Sep-2020 08:39
    Thanks, Bruno. I've just got some more specific updates from ANVISA, they will discuss the proposed regulation in October, in the next Mercosur meeting, and they expect it to be published in the first quarter of 2021.

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    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
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  • 4.  RE: RDC 185/2001 updating -Public consultation status

    Posted 16-Sep-2020 11:50
    Hello Bruno and Marcelo

    Thank you both for your answers, the information is very useful for me.

    Regards,

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    C.Oviedo
    RA Executive
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