All set with Swedish SmPCs for the Finnish market?

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As of 9 February 2022, all human and veterinary medicinal products with a marketing authorisation and traditional herbal medicinal products with a registration on the market in Finland must have a summary of product characteristics also in Swedish. Our dedicated Product Information Team consisting of translators and regulatory affairs experts has vast experience in national product information texts and the related regulatory requirements and is here to help you meet the deadline.

The requirement to submit a Swedish summary of product characteristics is based on Fimea’s Administrative Regulation 4/2019, according to which all marketing authorisation applications of medicinal products and registration applications of traditional herbal medicinal products submitted after 9 February 2019 should include a Swedish summary of product characteristics already at the application stage. This means that a marketing authorisation or registration will no longer be granted without a Swedish SmPC. The transition period for submitting a Swedish SmPC ending on 9 February 2022 applies to medicinal products that have been granted a marketing authorisation and registration on or before 9 February 2019.

For a quote for the Swedish translation and any help you may need with the submission of the Swedish SmPCs, please contact

Jesse Salonen
Support Operations Manager
jesse.salonen@medfiles.eu

For more information, please visit the Finnish Medicines Authority website at
www.fimea.fi

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