Summaries of product characteristics in Finnish and Swedish in future
According to the bulletin published on 8 November 2018 by the Finnish Medicines Agency Fimea, the summaries of product characteristics (SmPCs) of both human and veterinary medicines shall in the future be provided also in Swedish. This change is a part of reforms concerning the safety characteristics of medicinal products and it is planned to become effective on 9 February 2019.
You can access the Fimea bulletin via this link (NOTE: The bulletin is available in Finnish only):
”Fimean lääkkeiden turvaominaisuuksia koskevia määräyksiä ja ohjeita päivitetään”
(“Regulations and guidelines by Fimea concerning safety characteristics of medicines to be updated”)
The language reform regarding SmPCs will guarantee patient safety in the Swedish-speaking areas of Finland.
In case of new marketing authorization applications, the language requirement shall be adhered to from the set date onwards. Instead, a transition period in providing the translations will be applied for old marketing authorizations that have been applied via national procedure.
The new language requirement will especially increase work associated with providing translations. Please remember that the expert services unit of Biocodex, ”PhaMe”, offers you help in translating the SmPCs. Our translators, who are specialized in medical texts, will translate also more demanding texts with precision and professional skill.
Furthermore, the experienced and expert regulatory affairs team of PhaMe assists you in implementing variations. We handle variations easily and flexibly – saving you time and resources.
Heavy burden? Let’s make it lighter together!
Do not hesitate to contact us and ask for an offer for translation and regulatory work.
Hanna-Maija Koponen-Piironen
Director, BIOCODEX Pharmaceutical and Medical Services
h-m.koponen-piironen@biocodex.fi
tel. +358 50 539 1880