Fimea’s new requirement: SmPC in Swedish as of 9 February 2019

News • 17.11.2018

Summaries of Product Characteristics (SmPC) for medicinal products are in the future required in Finland both in Finnish and Swedish. Previously, only Patient Information Leaflets (PIL) and Labelling were submitted in both Finnish and Swedish, while SmPCs were only submitted in Finnish.

There will be a transition period of three years beginning from the date when the Administrative Regulation takes effect. Changes to current marketing authorisations should be made by type IB variation. This also applies to veterinary medicinal products. This new requirement is based on the Finnish Language Act.

This information means that a great number of new translations and variations will be needed, so start preparing your action plan already now.

  1. Plan your translation projects well ahead of time. Is it possible to use your Swedish SmPC almost directly, and if so, for which products? Which product information texts need a completely new translation? It is already certain that the requirement for Swedish SmPCs will take effect, so you can start your translation project already now.
  2. Consider a common pack for Finland and Sweden. This may mean that your product information texts need to be harmonised. It would be a good strategy to first identify the differences between the current product information texts and then harmonise your texts in a coordinated manner.
  3. Note that Finnish Poison Information Centre has a new telephone number. Fimea has not updated Blue box texts yet, but you can despite this already update the telephone number in your Patient Information Leaflets.

 

Contact us, if you need help with your texts. We can make use of efficient translation software and we also have good contacts with Nordic regulatory authorities.

News on Fimea website (in Swedish)