Nordic pilot of medicine packages in English for small-scale hospital products will continue   

The Nordic countries launched a joint pilot project on 1 January 2025 to test how medicine packages in English would promote the availability of small-scale hospital products in the region. 

The pilot project has been running for a year now and will continue as the number of medicinal substances included increases. Marketing authorisation holders must themselves apply for their products to be included in the pilot project.

In a joint pilot project launched a year ago, the Nordic countries – Finland, Sweden, Denmark, Norway and Iceland – declared that, in addition to the national language requirements required by pharmaceutical legislation, medicines with a package in English can also be approved. The policy applies to small-scale hospital products approved for the pilot project which have availability challenges in two or more Nordic countries. 

In practice, hospitals acquiring small-scale products may use common Nordic product packages with the texts in English and possibly also in one or several other EU languages in addition to English. However, the package leaflet in the local Nordic language will always be available in electronic form for healthcare professionals.

"The pilot has progressed positively, and we are delighted that marketing authorisation holders have applied to participate. We hope that the English-language medicine packages approved in the pilot will also be available in Finnish hospitals to secure patients' medication," says Marjo-Riitta Helle, Head of Section at Fimea.

New medicinal substances have been added to the list of active substances covered by the pilot

At the start of the pilot, 18 medicinal substances were included in the list of active substances in small-scale hospital products. The list has already expanded: it now includes 49 active substances or combinations of them. 

"Nordic pharmaceutical authorities continuously monitor the availability of medicines and assess the necessary means to ensure medicinal treatment," Helle adds. "We encourage pharmaceutical companies to apply for the Nordic pilot project."

The instructions and application procedures for the joint Nordic pilot project have been published on the website of the Swedish Medical Products Agency.

Apply here: How to prepare package labelling (MPA) 

The list of substances for which companies may apply is available (MPA)
 
Common pharmaceutical packages in the Nordics aim to improve availability (Fimea online news article 2 December 2024)

Language requirements to be simplified for common Nordic packages for hospital products (Fimea news article 22 October 2025)

Information on exemptions granted for Nordic flex EN/EN packages will from now on be published on Fimea’s website (Fimea online news article 14 November 2025)