null What should be attached to the application for addition?
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
1 Dec 2020