The European Medicines Verification System was launched on 9 February 2019. With the launch of the medicines verification system, Fimea updated some of its regulations and guidelines in Finland. In connection with this, a requirement has been added to the regulation “Applying for and maintaining a marketing authorisation and registration for a medicinal product”, stating that, in the future, summaries of product characteristics (SmPCs) for medicinal products must be available in both Finnish and Swedish. If a product does not yet have a Swedish-language summary of product characteristics, it must be added within three years of the regulation entering into force.
“Updating SmPCs to be bilingual is a big task for pharmaceutical companies, and it's a good idea to get started despite the three-year transition period,” says Laura Riihimäki-Lampén, Regulatory Affairs Team Lead.
Learn more about the updated regulations and guidelines on the Fimea web page in Finnish here.
Our Regulatory Affairs Team and Translation Team are happy to help you with all translations related to marketing authorisations for medicines, as well as with other regulatory services. Please contact Laura Riihimäki-Lampén or learn more about our regulatory services here.