What should be attached to the application for addition?

• cover letter
  If Sweden and Finland have participated in the same process and the Swedish Medical Products Agency (MPA) has approved a Swedish SPC for the product, this should be indicated in the cover letter. The cover letter must also include a declaration that the Swedish SPC approved by MPA is identical in substance to the Finnish SPC.
• application form
• a SPC in Finnish and in Swedish in Word format
• the latest approved common SPC, if applicable