Nordic regulatory news highlights October 2025

6 November 2025

From the newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from October 2025.

SWEDEN

Nordic pilot on English-language medicine packaging expanded

22 October 2025
The joint Nordic pilot project on English-language medicine packaging has been extended to allow, in certain cases, the use of English labelling and package leaflets alongside other EU languages. This regulatory change aims to improve patients’ access to essential medicines across the Nordic countries. Read more (in Swedish)

The pilot has also been highlighted by Fimea in Finland and by the Norwegian authorities.

SWEDEN

Criminal networks profit from illegal online medicine sales

23 October 2025
Organised crime is making substantial profits from people buying illegal medicines online, often marketed as treatments to boost potency, reduce weight, or relieve anxiety, according to preliminary findings from a survey conducted by the Swedish Medical Products Agency (Läkemedelsverket). Read more (in Swedish)

DENMARK

EU clinical trials map now available in all EU languages

23 October 2025
An interactive map offering up-to-date information on clinical trials across the EU, Norway, and Iceland is now accessible in all EU languages. The tool helps patients, healthcare professionals, and the public easily find information on ongoing and completed trials throughout the region. Read more

FINLAND

Fimea launches new website section on substances of human origin

29 October 2025
The Finnish Medicines Agency (Fimea) has introduced a new section on its website dedicated to substances of human origin (SoHO). The section provides clear and up-to-date information for professionals and the public, including details on regulations, guidelines, authorisation procedures, and supervision practices related to SoHO activities. Read more

How do these changes affect you?

Our experienced specialists are ready to help you navigate the regulatory landscape!

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.