Pilot project on English-only common Nordic packages for human medicinal products

Pilot project on English-only common Nordic packages for human medicines

Packages of medicinal products today must be presented in the relevant national language, and it is common practice in the Nordic region to use common packages that incorporate multiple Nordic languages. A pilot project will examine the usability of using English on the packages of medicinal products and in the package leaflets for selected medicinal products.

The pilot project will be limited to medicinal products that are administered by healthcare professionals and will thus exclude medicinal products handled by the patients themselves. The package leaflet will still be available online, in Danish for healthcare professionals or patients.  

The pilot project intends to test the usability of packages in English in all the Nordic countries, i.e. Denmark, Finland, Iceland, Norway and Sweden. The aim is to ensure the security of supply of important hospital products in all Nordic countries.

A guideline and request form have been prepared jointly by the regulatory authorities in the Nordic countries: “Guideline on common Nordic EN/EN only packages” and “Request for exemption to allow common Nordic EN/EN only packages for human medicinal product(s)”. Both are available on the website of the Swedish Medical Products Agency.

The documents apply to selected hospital products that are produced in small volumes and appear on the Nordic list on product information, aimed to increase availability for products with a history of supply instability.

The guideline offers general information about the pilot project, the medicinal products included in the project and the process for applying for exemption.

When applying for common Nordic packages in English, a simultaneous request must be made for exemption from the requirement for packages in the national language, in accordance with Article 63(3) of Directive 2001/83/EC.

Participation in the pilot project is contingent upon the granting of an exemption to market common Nordic packages in the English language using the form "Request for exemption to allow common Nordic EN/EN only packages for human medicinal product(s)".

Proposed English texts must be submitted with the request form. Further instructions and information on requirements are provided in the ”Guideline on common Nordic EN/EN only packages” available on the website of the Swedish Medical Products Agency.

The pilot project runs from 1 January 2025 and for an estimated five-year period.