Granted Exemptions (Nordic flex EN/EN packages)

EN Myönnetyt Nordic flex EN/EN -pakkausten poikkeusluvat

The Nordic medicines authorities (Denmark, Finland, Norway, Sweden, and Iceland) have collaborated to increase the number of joint Nordic medicine packages. The aim is to improve the supply security and availability of certain critical, low-demand hospital preparations in all Nordic countries by allowing the use of English on the packaging. For products with marketing authorization obtained through the centralized procedure, it is possible to approve the use of another European language on the packaging in addition to English.

On this page, we publish information about the granted exemptions for Nordic flex EN/EN packages for the period 1.1.2025–1.1.2030.

Lists of exemptions for Nordic flex EN/EN packages:

Granted exemptions for Nordic flex EN/EN packages from 1.1.2025 (pdf)

The list provides the following information about the exemptions:

  • The product for which the exemption has been granted
  • The package sizes covered by the exemption
  • The name of the marketing authorization holder in Finland
  • The period for which the exemption has been granted
  • The date the exemption was granted
  • ATC code
  • EN+other EU language (only those products with marketing authorization obtained through the centralized procedure)

Exemption request (lakemedelsverket.se)

Read more:

How to prepare package labelling | Swedish Medical Products Agency | Läkemedelsverket

For more information, please contact [email protected].