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Do we need to give a dealer proprietary formula in South Korea to register devices and drugs....Anybody with S.Korea Experience?

  • 1.  Do we need to give a dealer proprietary formula in South Korea to register devices and drugs....Anybody with S.Korea Experience?

    Posted 13 days ago


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    Yemi
     
    Ijose
    Regulatory Affairs Senior Manager
    GC America Inc.
    3737 W 127th St
    , 
    Alsip
    , 
    IL
     60803
    Tel: 
    +1708-926-3246
    Email: 
    Yemi.Ijose@gc.dental
    Web: 
    www.gcamerica.com
     
     
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  • 2.  RE: Do we need to give a dealer proprietary formula in South Korea to register devices and drugs....Anybody with S.Korea Experience?

    Posted 12 days ago
    Yes, if they are obtaining/holding the license  actually you will have to give them.all the technical information so they can put together the submission dossier.

    I would advise against letting a distributor/dealer own the license. This can easily handcuff you in the future.   

    I think you should look for a CRO or other independent in-country agent to do your filing, unless you have a subsidiary there yourself.





    Original Message


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