Common nordic packages for better availability
Starting from the new year, a pilot project will introduce English-language common nordic packages. This aims to improve the availability by simplifying production and distribution.
The Nordic medicine agencies are collaborating on a project to increase the number of common Nordic packages. The project will test how English-language common nordic packages will work across all Nordic countries: Denmark, Finland, Iceland, Norway, and Sweden.
The goal is to enhance supply security and availability to essential hospital products in all Nordic countries, ensuring that Nordic patients have access to more medicines.
Preventing Shortages
There has long been a shortage of several essential medicines in the Nordic markets. Each Nordic country, being a relatively small market, is less attractive than larger markets. This issue often affects medicines used by small and specific patient groups that are rare but vital. Securing enough medicines becomes more challenging when separate packages in different languages are required.
Currently, there is a requirement for national languages on packages, and there is extensive use of common Nordic packages that includes various Nordic languages. The new pilot explores using only English for packages and the printed package leaflets for certain selected, particularly vulnerable medicinal products.
The intention is not for healthcare personnel and patients to have to read the English package leaflets. Package leaflets in all the Nordic languages will be digitally available.
Improved Access
"We hope this project will contribute to better access to essential medicines. Reducing the use of Nordic languages on certain packages is feasible as we have digital package leaflets available. These are always up-to-date and accessible to both patients and healthcare personnel," says Hanne Lomholt Larsen, Director of Department, Danish Medicines Agency.
This pilot allows medicines produced in low volumes and listed on a shared list to be exempt from Nordic language requirements. This applies to certain hospital medicines, administered by healthcare personnel.
Application process for companies
The pilot allows marketing authorisation holders to apply for their products to be included in the pilot.
"We encourage relevant pharmaceutical companies to apply for participation in the pilot to strengthen supply security for these medicinal products throughout the Nordics. This can simplify production and distribution, and also help ensure that patients gain better access to essential medicines," says Hanne Lomholt Larsen.
The pilot will last for five years.
For more information on which medicinal products are eligible for the pilot and guidance on applying for English-language common Nordic packages, see:
Pilot project on English-only common Nordic medicine packages for human medicines (dkma.dk)