28 August 2025
From the newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from July to August 2025.
SWEDEN
SweTrial initiative launched to boost clinical trials in Sweden
31 July 2025
The Swedish government has decided to establish the SweTrial partnership, aimed at strengthening Sweden’s position as a life science nation and facilitating the conduct of clinical trials in the country. The decision also includes the creation of a dedicated SweTrial office at the Medical Products Agency (Läkemedelsverket). Read more (in Swedish)
SWEDEN
Licence requirement for 4-piperidone and 1-boc-4-piperidone
13 July 2025
From 14 August 2025, companies that possess or sell 4-piperidone or 1-boc-4-piperidone need a licence from the Swedish Medical Products Agency (Läkemedelsverket). Read more (in Swedish)
SWEDEN
Swedish MPA offers generative AI tool to EU medicines regulators
7 July 2025
The Swedish Medical Products Agency (Läkemedelsverket) has launched its in-house generative AI system, REGULUS, making it available to medicines authorities across the EU/EEA. Already in internal use since March 2025, REGULUS is now accessible via the agency’s AI@MPA toolbox cloud service, with access offered to 22 agencies in 20 countries and open to all EU/EEA member states. Read more (in Swedish)
SWEDEN
Five new substances classified as narcotics in Sweden
2 July 2025
The Swedish government has decided that five substances will be classified as narcotics from 15 July 2025. The Medical Products Agency (Läkemedelsverket) has updated its regulations on controlled substances accordingly. The newly scheduled substances are: 3-methyl-alpha-PiHP, pyrofenidone, 2-chloromethcathinone (2-CMC), ADB-4en-5Br-PINACA, and spirochlorphine (R-6890). Read more (in Swedish)
DENMARK & FINLAND
DKMA warns of falsified medicines sold online
21 August 2025
The Danish Medicines Agency has raised concerns about a growing number of falsified and illegal medicines and medical devices promoted on unauthorised websites and social media. Fraudulent sellers are misleading consumers by misusing the agency’s logo and those of other authorities, putting patient safety at risk. Read more
Fimea in Finland also issues a warning about online scams. Read more
NORWAY
Norway launches FHIR service for structured medicines data
13 August 2025
As part of the SAFEST project, a new FHIR-based service has been introduced to provide structured medicines information for use across the healthcare system. The service enables standardised data exchange, supporting safer and more efficient medicines management. Read more (in Norwegian)
NORWAY
New EQ-5D-5L tariff mandatory in Norway from September 2025
9 July 2025
From 1 September 2025, the new Norwegian EQ-5D-5L tariff must be used when documenting health-related quality of life for adults in submissions for health technology assessments. The requirement applies to pharmaceutical companies, medical device suppliers, and professional groups preparing documentation packages. Read more (in Norwegian)
NORWAY
Norwegian Medicines Standards 2025.2 published
1 July 2025
The Norwegian Medicines Standards (NLS) 2025.2 have been released, providing an updated overview of all standards and pharmacopoeial monographs applicable in Norway for raw materials, dosage forms, and pharmaceutical preparations. Read more (in Norwegian)
FINLAND
Fimea launches one-stop access to E-services
20 August 2025
Fimea has introduced a new front page for its E-service portal providing centralised access to all services. Users can now manage pharmacy licences, special permits, adverse reaction reports, operator and device notifications, shortage notifications, and NIS2 entity notifications in one place. Read more
ICELAND
New procedures: Maximum wholesale price for prescription medicines
15 July 2025
The main goal of the changes is to protect the availability of low-cost, low volume marketed medicines in Iceland and to increase the number of marketed products. Read more (in Icelandic)
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