For a long time, The Nordic countries have faced shortages of certain critical medicines. Each country represents a small market and is therefore less attractive. This issue becomes particularly evident and critical when it comes to life-saving medicines that are rarely used and intended for small, specific patient groups.
The Nordic pilot project
The Nordic medicines agencies are collaborating on a pilot project which began in January.
The pilot introduces common Nordic packages with English text both on the packaging and in the printed package leaflet inside the carton.
The first approved medicines
The first two medicines recently approved under this scheme are:
- Iqtopam (clonazepam) used for epilepsy
- Mozobil, (plerixafor), used in connection with stem cell transplantation for certain types of cancer.
- These medicinal products are considered particularly vulnerable to shortages and are sold in low volumes in the Nordic region. It is entirely safe to have English text on the packages as healthcare professionals uses digital package leaflets that are always up to date, says Dag Jordbru, Strategic Director at the Norwegian Medical Products Agency (NOMA).
An important opportunity
There are requirements for national languages on packaging, and today, common Nordic packages with various Nordic languages are widely used. Producing separate packages in different languages makes production and logistics more challenging. By allowing common Nordic packages with English text, the approval process in all Nordic countries becomes more efficient.
- It is very encouraging that manufacturers see this as an important opportunity to enhance supply security and wish to participate in the new scheme, says Jordbru.
Children
The challenge of shortages has been particularly noticeable in relation to children, who often represent a very small patient group.
- Both of these medicines can be used in children, which clearly demonstrates how important common Nordic packages and digital package leaflets are in reducing our vulnerability, says Jordbru.
Digital package leaflets - always updated
It will take time before the new English-language packages reaches healthcare providers, likely not until autumn. Healthcare professionals should, regardless, continue to use the digital package leaflets, which are always updated and available in Norwegian.
The pilot project includes some hospital medicines administered by healthcare professionals. The system works such that the pharmaceutical companies, i.e., the holder of the marketing authorisation, applies for participation in the pilot. Learn more about the application process and types of medicines here.