Marketing authorisation holders must provide Swedish summaries of product characteristics for medicines within a transition period ending in 2022

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As of 9 February 2019, submission of Swedish summaries of product characteristics has been a mandatory requirement for all new marketing authorisations of human and veterinary medicinal products in Finland.

A Swedish summary of product characteristics is required for all marketing authorisation applications submitted after 9 February 2019. For marketing authorisations already issued as well as for marketing authorisation applications submitted before 9 February 2019, a three-year transition period is allowed. The transition period will end on 9 February 2022.

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.

For more information or a quote on our expert services, contact translations@medfiles.eu.

More information:

The Finnish Medicines Agency Fimea requires Swedish summaries of product characteristics

Swedish summary of product characteristics for medicines to be provided within a transition period

Administrative Regulation 4/2019 (pdf)

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