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Guidance for submission of product information

24.04.2017
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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.