In which format should the summary of product characteristics in Swedish be submitted?
A summary of product characteristics (SPC) in Swedish should be submitted in one Word-document following the Finnish version of the SPC same way as the package leaflet is submitted already. Both Finnish and Swedish summary of product characteristics need to have the same date.
It should be mentioned in the cover letter of the application if Sweden and Finland have taken part to the same procedure and MPA has approved the Swedish SPC. There should be also included in the cover letter a confirmation that the Swedish SPC approved by MPA doesn’t differ from the Finnish SPC in a subject matter.