The legislation is clear on the importance of national languages. We therefore like to emphasize that this is a third/last hand option that is not optimal. The first hand option is Nordic packages with national languages especially for hospital products with complicated preparation and administration instructions. The second hand choice is an English only package.
Strengthen supply and availability
For nearly a year, a joint Nordic pilot project has enabled marketing authorisation holders (MAHs) of low-volume hospital medicines to use common Nordic packages with English only text on both packaging and the printed package leaflet. To further strengthen supply and availability, the pilot is now extended to allow English in combination with other EU languages on the packaging.
Essential treatments reach patients
“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 NOMA.
In practice, when the Nordic markets are too small, hospitals can use common Nordic packages labelled in English, which may also include one or more additional EU languages besides English.
Market larger than the Nordic
"This strengthen supply security and protect patient safety. “Sometimes a market larger than the Nordic region is necessary for manufacturers to justify supplying our smaller countries,” Jordbru adds.
The small size of the Nordic markets has proven particularly challenging for low-volume hospital medicines.
Beneficial for hospitals and patients
“Adapting regulatory requirements like this is beneficial for hospitals and patients, who might otherwise risk lacking life-saving treatment. Healthcare professionals and patients should in any case use the digital package leaflet, which is always up-to-date, accessible, and available in Norwegian or the relevant national language”, says Jordbru.
This new arrangement applies only to products authorised through EMA’s centralised procedure and those included in the Nordic pilot scheme. MAHs must apply for their products to be included in the pilot.
MAHs can apply
We encourage MAHs and pharmaceutical companies to apply to have their eligible products includet/include eligible products in this scheme.