Regulatory Open Forum

 View Only

  • 1.  language

    Posted 12-Oct-2012 16:50

    Hi,
    I have a question regarding the language requirement. If US drug/device is marketed in Spain or Mexico, the labelling informations should be provided in Spanish language?
    Thanks in advance.


    -------------------------------------------
    Keya Bandyopadhyay RAC
    Senior Scientist
    Torrey Pines Institute For Molecular Studies
    San Diego CA
    United States
    -------------------------------------------


  • 2.  RE:language

    Posted 15-Oct-2012 11:27
    Dear Keya,

    To operate in the EU (Spain) you must first obtain a CE-mark for your product and its labeling must be in Spanish. If you have not yet obtained a CE-mark, do that step first.
    For Mexico, your Spanish labeling is acceptable however there are subtle differences between EU Spanish and Latin American Spanish, as there are between EU Portuguese and Brasilian Portuguese. But Mexico (and Brasil) will accept EU Spanish or EU Portguese) labeling.

    -------------------------------------------
    Aimée Campbell
    Abbott Vascular
    Menlo Park CA
    United States
    -------------------------------------------






    Original Message


  • 3.  RE:language

    Posted 15-Oct-2012 15:16
    Hi Keya,

    Mexico and Spain require the package inserts in Spanish for devices. 

    -------------------------------------------
    Roshni Mehta
    Manager, Regulatory Affairs
    QIAGEN
    Gaithersburg MD
    United States
    -------------------------------------------






    Original Message