Fimea´s regulation update: Summaries of product characteristics for medicines also in Swedish

The European Medicines Verification System was launched on 9 February 2019. With the launch of  system, Finnish Medicines Agency (Fimea) updated some of its regulations and guidelines in Finland.

According to one important regulation update, summaries of product characteristics (SmPCs) for medicinal products must be available in both Finnish and Swedish in the future.  If a product does not yet have Swedish-language summary of product characteristics, it must be added within three years of the regulation entering into force and have to be available by February 2022 at the latest.


“Updating SmPCs to be bilingual is a big task for pharmaceutical companies. To get the work done in time, it’s better to start now rather than later. says Laura Riihimäki-Lampén, Regulatory and Translations  Team Lead.

Learn more about the updated regulations and guidelines on the Fimea web page in Finnish here.

Our Regulatory Affairs and Translation experts are happy to help you balance your workload and can take care of the entire project for you, including high-quality translations.

We are happy to tell you more!

Laura Riihimäki-Lampén

Laura Riihimäki-Lampén

Head of Regulatory Affairs and Translations
Phone Icon +358 50 409 9161

Regulatory life cycle management

We are ready to tackle your challenges in regulatory affairs, pharmacovigilance and medical information in the Nordics and will provide high-quality translations.

Read more