The Finnish Medicines Agency Fimea Requires Swedish Summaries of Product Characteristics


As of 9 February, submission of Swedish summaries of product characteristics is a mandatory requirement for all new marketing authorisations of human and veterinary medicinal products in Finland. Thus, all product information; SPC, PL and labelling, must be available both in Finnish and Swedish. As regards already granted marketing authorisations, a transition period of three years will be applied.

Translation of product information texts is one of Medfiles’ core competencies. Our in-house team is happy to help you to translate or update your product information to meet the new national requirements. In addition to Swedish and Finnish translations, Medfiles offers translation services to and from English, and with the help of our expert network we can also offer translations to and from other Nordic and Baltic languages.

Contact to get more information or a quote on our expert service. Your product information is in good hands.

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