5 February 2026
From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from the past month.
SWEDEN
Swedish MPA launches a new operational area for medical devices
7 January 2026
Since the turn of the year, the medical devices operational area has been established at the Swedish Medical Products Agency. The aim is to make the Agency’s work in this area clearer and better equipped to meet a rapidly evolving landscape. Read more (in Swedish)
SWEDEN
Sleep in focus in a new government mandate
12 January 2026
The Swedish Medical Products Agency has been tasked by the government with developing a new evidence base for the use of melatonin and other medicines used to treat sleep problems in children and young people, as well as in adults. The assignment is set out in the Agency’s appropriation directions for the 2026 budget year. Read more (in Swedish)
SWEDEN
Funding allocated for an evidence base on decentralised clinical medicinal trials
27 January 2026
Uppsala Clinical Research Center (UCR), Region Uppsala, has received funding from Swetrial for a project to revise the Swedish evidence base for decentralised clinical medicinal trials (DCTs) – an approach that can make clinical trials more accessible and less burdensome for patients. Read more (in Swedish)
DENMARK
Denmark sets 2026 GMP inspection focus on dossier compliance
23 January 2026
The Danish Medicines Agency will prioritise checks in 2026 on whether GMP manufacturers comply with the requirements approved in their product dossiers. As dossiers form the basis of marketing authorisations, the focus reinforces expectations that manufacturing practices remain fully aligned with authorised specifications throughout a product’s lifecycle. Read more
FINLAND
Finland names new national medicines data repository Farmasto
17 December 2025
Finnish authorities have confirmed that the new national medicines data repository will be called Farmasto, bringing together official, up-to-date medicines information in a single digital platform. Due to launch at farmasto.fi, the repository is intended to transform how medicines data are managed and accessed by authorities and stakeholders. Read more
FINLAND
Fimea publishes guidance on AI use in medical devices
19 January 2026
Fimea has launched a new guidance page bringing together key requirements for the use of artificial intelligence in medical devices, aligned with the phased implementation of the EU AI Act, which entered into force in August 2024. The page will be updated over time as the Act is applied and additional guidance becomes available, helping manufacturers keep pace with evolving regulatory expectations under the Finnish Medicines Agency (Fimea). Read more
FINLAND
Fimea to expand sales channels for non-prescription medicine
2 February 2026
Finnish Medicines Agency (Fimea) has begun preparations for widening the sales channels for non-prescription medicines following a legislative amendment approved by Parliament. From the start of 2027, selected over-the-counter medicines will be allowed to be sold outside pharmacies, giving consumers more options while reshaping the retail landscape for non-prescription products. Read more
ICELAND
Regulators stress importance of maintaining medicine availability
22 January 2026
Authorities are highlighting the need to carefully manage the availability of medicines, noting that market withdrawals can cause significant disruption for patients. Marketing authorisation holders are encouraged to consider patient impact early and take appropriate steps to minimise supply interruptions. Read more (in Icelandic)
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