First common Nordic packages in English approved

The first two common Nordic medicinal products with texts in English have just been approved for use in all Nordic countries, following a pilot that was launched to make the small Nordic markets more attractive and to improve the supply of important medicines.

For a while, important medicines have been in short supply on the Nordic markets – markets that are each considered small and thus less attractive to the pharmaceutical companies. This is especially problematic for critical medicines that are essential to individual patients, yet are rarely used and aimed at small, specific patient groups.

The Nordic drug regulatory authorities therefore joined forces in a pilot launched in January. The pilot introduces common Nordic medicinal product packages with English text on the package and in the printed package leaflet inside.

The first two medicines recently authorised under the scheme are:

• Iqtopam (clonazepam) – a product for the treatment of epilepsy, and
• Mozobil (plerixafor) – a product used in connection with stem cell transplantation in certain forms of cancer.

“These are products considered especially vulnerable to supply failure, and they are only sold in small volumes in the Nordic region. We don’t foresee any problems having English text on the package, as the healthcare professionals use digital package leaflets that are always updated,” says Hanne Lomholt Larsen, Director at the Danish Medicines Agency.

Medicinal product packages must be in the national language, and, today, common Nordic packages with different Nordic languages are widely used. Having packages in multiple languages places heavy demands on production, logistics and distribution, whereas common Nordic packages make it easier to have products approved for sale in all Nordic countries.

“It’s very positive that the manufacturers are willing to participate in the pilot and consider it an important opportunity to improve the security of supply,” says Hanne Lomholt Larsen.

It will be some time before the packages in English will reach the healthcare sector; probably not before autumn. In any case, healthcare professionals should continue using the digital package leaflets, which are always updated and available in Danish.

The pilot covers specific hospital medicines administered by healthcare staff. Under the scheme, the supplier of a medicine, i.e. the marketing authorisation holder, applies to have their product included in the pilot. Visit this page for more information on the application process and types of medicines (lakemedelsverket.se).