All authorisations granted to pharmaceutical companies to use joint Nordic English-language packaging will now be extended until 2035.
Since January 2025, the Nordic countries have been running a pilot on joint Nordic package leaflets in English. Under the pilot, pharmaceutical companies may apply for permission to use English-language packaging instead of packaging in the national language.
Aims to improve availability of important medicines
The pilot was launched in response to shortages of certain important medicines in the Nordic markets, which are relatively small and therefore less commercially attractive. Securing sufficient supply can be challenging when manufacturers need to produce separate packs for several different language markets.
“We hope this project will help improve access to important medicines. Removing Nordic languages from some packs is possible because package leaflets are also available electronically. These electronic package leaflets are always up to date and accessible to both patients and healthcare professionals, says Dag Jordbru, Strategic Director at the Norwegian Medical Products Agency (NOMA).
Extending the pilot to give industry greater predictability
As a general rule, medicinal product packaging must be in the national language. At the same time, joint Nordic packs that include several Nordic languages are already widely used. This pilot allows selected medicinal products to use English on both the outer packaging and in the printed package leaflet.
The authorisations issued under the pilot are now being extended until 2035.
“The reason for extending these authorisations is to provide industry with greater predictability and a longer planning horizon, encouraging more companies to take part in the pilot. Changes to packaging takes time to implement, and a longer time horizon is therefore important also in order to make a proper evaluation”, says Jordbru.
The change also applies to authorisations already granted
The extension to 2035 also applies to authorisations that have already been granted under the pilot. Companies that have all received permission to use joint Nordic package leaflets will receive updated authorisations from all Nordic countries, with a revised end date, during the first half of September.
Go to Swedish Medical Products Agency website to find application form
Read more about the pilot here: