Language requirements to be simplified for common Nordic packages for hospital products

From now on, common Nordic pharmaceutical packages for hospital products can be approved in English in connection with EU languages. It is hoped that the new policy will further improve the availability of important but small-scale hospital products in all the Nordic countries.

Legislation requires the use of the national languages in package labelling. The pharmaceutical authorities stress that the primary option also in the Nordic package of a hospital product is the national languages. The importance of this is emphasised especially in hospital products with demanding instructions for healthcare professionals on how to prepare them for use and how to dose them.

For almost a year now, relaxing the language requirements for the package labelling of certain small-scale hospital products has been tested in a joint pilot project with marketing authorisation holders by allowing the package and the printed package leaflet with text only in English. To improve accessibility, the pilot project will now be expanded, and from now on, English texts together with another EU language will also be allowed for the packages of hospital products.

Bringing essential care within reach of patients

“By also approving a version in which other EU languages may appear on the package in addition to English, we will significantly widen the possibilities of obtaining some very small-scale products for the use of hospitals in Finland,” says Marjo-Riitta Helle, Head of Unit at Fimea.

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.

Markets of hospital products larger than the Nordic countries

It is hoped that the new policy will further strengthen the availability and patient safety of small-scale hospital products. The small size of the Nordic pharmaceutical market has proved to be particularly challenging.

“The now introduced wider authorisation of other EU languages for package labelling alongside the English text may also enable availability in Finland in very rare, critical medication situations. However, the package leaflet in Finnish/Swedish will always be available in electronic form for healthcare professionals,” Helle adds.

Marketing authorisation holders can still apply for participation in the pilot project

The new policy applies only to hospital products authorised through the centralised procedure of the European Medicines Agency and accepted to the joint Nordic pilot project. Marketing authorisation holders must themselves apply for their products to be included in the pilot project.

“We encourage marketing authorisation holders and pharmaceutical companies to apply to the programme with their applicable products,” says Helle.

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) 

More on the pilot project: Common Nordic packages in English language approved (NOMA) 

Fimea online news article 2 December 2024