On 5 August 2020, the Finnish Medicines Agency Fimea published a reminder on its website stating that a summary of product characteristics in Swedish must be submitted for products with a marketing authorisation by 9 February 2022. The Finnish Medicines Agency 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.
For those products that do not yet have a summary of product characteristics in Swedish, it must be added no later than within 3 years from the entry into force of the Administrative Regulation. Fimea’s news mentions that up until now, a Swedish-language summary of product characteristics has been submitted and approved only for 18.9% of all medicines for human use and only for 7% of veterinary medicines.
“Our highly skilled Regulatory Affairs and Translations team has already compiled and translated many summaries of product characteristics in Swedish, and we are happy to help companies in this sizeable task,” says Laura Riihimäki-Lampén, Head of Regulatory Affairs and Translations.
See the updated regulations and guidelines at Fimea’s website by clicking here.
Our Regulatory Affairs and Translations teams are pleased to help you with all translations related to marketing authorisation of medicinal products and in other marketing authorisation-related tasks. Please contact Laura Riihimäki-Lampén or read about our Regulatory Affairs services here.