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    Guidance for submission of product information

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    SPC, PIL and labelling in Estonian should be presented with the application electronically in Word format in the following cases:  

    • submission of the application for marketing authorisation and renewal applications in national procedure;
    • submission of the application for variation to a marketing authorisation introducing changes to the product information
         - via national procedure: all variations
         - via MRP/DCP: type IA and IB variations

    In case the product information in Estonian has not been submitted with the application, it must be sent to documentation@ravimiamet.ee.

    For variations and renewals the last approved product information has to be used, all changes in the text should be made only using ‘track changes’ function.

    MRP/DCP initial applications and type II variations: Estonian translation of the final approved product information has to be submitted no later than 5 days after the procedure is closed to mrp@ravimiamet.ee.

    Product information (SPC, PIL and labelling) in English in Word format must be submitted together with MRP/DCP applications.


    Agreed templates have to be used.