Fimea’s Administrative Regulation update: SmPCs are also required in Swedish

According to Finnish Medicines Agency's (Fimea) updated Administrative Regulation, a Swedish-language summary of product characteristics must be submitted for each product with a marketing authorisation by 9 February 2022. The Fimea's Administrative Regulation 4/2019 “Applying for and maintaining a marketing authorisation for a medicinal product” contains a requirement stating that, in the future, summaries of product characteristics for medicinal products must be available in both Finnish and Swedish.

If a product does not yet have a summary of product characteristics in Swedish, this must be added no later than within 3 years from the entry into force of the Administrative Regulation, i.e. by 9 February 2022. In October 2021, Fimea reported at the Marketing Authorisation seminar that a Swedish-language summary of product characteristics had been submitted and approved for 51.1% of all medicines for human use and 36.9% of veterinary medicines.

“Our skilful Regulatory Affairs and Translations team has already compiled and translated numerous summaries of product characteristics in Swedish and submitted related variation applications to the Finnish Medicines Agency on behalf of our clients. If a company has not submitted the required files yet, now is the last minute to get started. We are glad to help companies in this extensive project, and if a company so wishes, the entire project from translation to the approval of variation applications can be outsourced to us”, says Laura Riihimäki-Lampén, Head of Regulatory Affairs and Translations.

See the updated regulations and guidelines at Fimea’s website in Finnish by clicking here.