For nearly a year, a special Nordic pilot project has been underway, designed to improve access to essential but rarely used medicines for hospital use. The project has allowed such medicines to be marketed in packaging with information exclusively in English. Now, the pilot project has been updated to permit the marketing of these medicines in packaging with English text, along with another European language.
It is important to note that this arrangement should only be considered as a last resort for marketing a medicine and under specific circumstances. Legislation is clear regarding language requirements. The first option should always be that medicines are packaged with texts and labeling in the native language of each country, especially for hospital medicines requiring complex preparation of doses or administration. The second option would be labeling exclusively in English, and the last option would be labeling in English and another European language.
Access to essential medicines
"Allowing common Nordic packages in English together with additional languages streamlines manufacturing and increases the likelihood that important treatments reach patients," says Dag Jordbru, Strategic Director at the Norwegian Medicines Agency (NOMA).
The small size of the Nordic market presents significant challenges, particularly regarding rarely used medicines administered in hospitals. In such cases, hospitals may use packaging with English labeling alongside another European language.
Jordbru explains that adaptations such as this are beneficial for hospitals and patients, who might otherwise risk lacking life-saving treatment. Digital package leaflets should always be up-to-date, accessible, and available in the relevant national language for both healthcare professionals and patients.
This initiative applies only to medicines that have received marketing authorization through the centralized EMA registration process and those included in the Nordic pilot project. Marketing authorization holders must apply specifically for participation in the project for each medicine.
If there are any questions on the project you can contact the Icelandic Medicines Agency on our web via Contact us > Send an email > Marketing authorization and registrations.