Regulatory Open Forum

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  • 1.  English Translation of Swissmedic regulations

    Posted 20-Dec-2011 11:51
    Hi,

    We are looking for an English translation of the Swissmedic regulatory guidelines and procedures for registration of pharmaceuticals.
    Any source for the classification of variation will be useful.

    Heard there are official providers for such services.
    Any link will be appreciated.


    Many thanks,
    Shavit

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    Shavit Fragman
    Senior Director Regulatory Affairs
    Omrix Biopharmaceuticals
    Rechovot
    Israel
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  • 2.  RE:English Translation of Swissmedic regulations

    Posted 05-Jan-2012 09:42
    Hi,

    what information exactly are you looking for?

    Did you try the English webpage of Swissmedic?
    http://www.swissmedic.ch/index.html?lang=en

    Kind regards,
    Markus

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    Markus Waelti
    Regulatory Affairs Manager
    Institut Straumann AG
    Basel
    Switzerland
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