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Common pharmaceutical packages in the Nordics aim to improve availability

2.12.2024 | Published in English on 3.12.2024 at 13.49

For decades now, the Nordic pharmaceutical authorities have worked together to increase the availability of medicines in our countries with common Nordic packages for medicines. The aim of this new availability project is to improve the availability of critical hospital products in all Nordic countries by simplifying production and distribution.

A pilot starting at the beginning of 2025 will be testing the usability of having some Nordic hospital product packages in English in all the Nordic countries: Denmark, Finland, Iceland, Norway and Sweden. 

Shortages are a particular problem of small markets

There has been a shortage of several vital medicinal products in the Nordic market for a while now. Each Nordic country is a relatively small market, which makes them individually less attractive compared to larger market countries. Availability problems are unfortunately common in rare but vital medicines used by small, specific patient groups. 

At present, package labelling is required to be in the national languages. There have already been some common Nordic packages with several Nordic languages. However, ensuring sufficient access to medicines is challenging when separate packaging in different languages is required.

Pilot on exempting certain critical hospital medicines from Nordic language requirements for medicine packages

The pilot project examines whether certain small-scale but critical medicinal products can be exempted from Nordic language requirements and how only using English in packaging would work in practice. The pilot only includes hospital medicines that are administered by health care professionals.

Even so, the aim is not to force health care professionals and patients to only read package leaflets in English, and digital copies of the package leaflets will still be available in all Nordic languages.

“We hope that this project will improve the availability of vital medicines. Reducing the use of Nordic languages in certain packages is possible because up-to-date digital package leaflets in all languages are available to health care professionals”, says Marjo-Riitta Helle, Head of Section at Fimea, who works in the Nordic pharmaceutical authorities’ cooperation group for the project in question.

This pilot allows deviating from the Nordic language requirements with a jointly agreed product list. The list only includes small-scale hospital products that are administered by hospital staff.

Pharmaceutical companies can now apply to join the pilot

Marketing authorisation holders can apply to have their small-scale products included in the pilot. The pilot will last five years.

“We encourage pharmaceutical companies to participate in the pilot! Deviating from the language requirement for small-scale products will streamline production in the Nordic countries while helping to ensure that patients are more likely to receive their medicines”, Helle says.

For more information on the medicines eligible for the pilot and instructions for submitting an application, go to the website of the Swedish Medical Products Agency at: How to prepare package labelling | Swedish Medical Products Agency | Läkemedelsverket 

Enquiries: 

About the pilot and the medicines eligible for the pilot: 

Marjo-Riitta Helle, Head of Section, tel. +358 29 522 3320

About applying to the project and the process: 

Sirpa Lohi, Research Coordinator, tel. +358 29 522 3382

Email addresses are in the format [email protected]

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