30 September 2025
From the newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from September 2025.
SWEDEN
New European campaign stresses safe use of non-prescription medicines
15 September 2025
A new awareness campaign from Europe’s medicines authorities reminds the public that over-the-counter medicines are not without risks. The initiative urges people to read the patient leaflet, follow instructions carefully, and use medicines responsibly. Read more (in Swedish)
The campaign has also been highlighted by Fimea in Finland and by the Icelandic Lyjastofnun.
SWEDEN
Stable supply of GLP-1 receptor agonists in Sweden
17 September 2025
The supply of GLP-1 receptor agonists, used in the treatment of type 2 diabetes, has now stabilised. The Swedish Medical Products Agency reports no recent shortage notifications or disruptions. Read more (in Swedish)
SWEDEN
Swetrial allocates SEK 10 million to Biobank Sweden
23 September 2025
Biobank Sweden has received SEK 10 million as part of the establishment of Swetrial. The funding will be used to strengthen sample handling and biobank infrastructure linked to clinical trials. Read more (in Swedish)
DENMARK
Updated information on GCP inspections published
2 September 2025
New updates on Good Clinical Practice (GCP) inspections have been released on the website. The revisions reflect Regulation (EU) No 536/2014 and the ICH E6 R3 guideline, with text adapted accordingly. Read more
DENMARK
Proposed changes to Cannabis Flower monograph open for consultation
11 September 2025
The European Pharmacopoeia has released draft revisions to the Cannabis Flower monograph, now available for public consultation. Stakeholders can review and comment through Pharmeuropa Online, Issue 37.4. Read more
NORWAY
New FHIR service launched to support medicines management
1 September 2025
The SAFEST project has introduced a new service providing structured medicines information for use in healthcare. The platform exchanges data in the FHIR format, creating a foundation for more efficient medicines management. Read more
NORWAY
NOMA launches new platform for marketing authorisation processing
22 September 2025
On 17 September, the Norwegian Medicines Agency (NOMA) introduced a new, more flexible system for handling marketing authorisation applications, renewals, and variations. The updated platform replaces the agency’s previous case processing system. Read more
FINLAND
Fimea to merge national networks into single body from 2026
1 September 2025
From the start of 2026, Fimea will consolidate the activities of its three coordinated networks — the National Medicines Information Network, the Research Network for Rational Pharmacotherapy, and Fimea’s Patient Advisory Board — into one broader national network. Read more
FINLAND
Fimea warns public about fake online pharmacies
2 September 2025
The Finnish Medicines Agency (Fimea) has issued a warning about the rise of fraudulent websites posing as legitimate pharmacies. These sites sell unauthorised products marketed as medicines, posing risks to public health. Read more
FINLAND
Study finds Finnish media focus heavily on GLP-1 obesity drugs
9 September 2025
Research by the University of Eastern Finland and Fimea shows that Finnish news coverage has strongly emphasised GLP-1 agonists such as semaglutide for obesity, while giving limited attention to other new medicines. Preliminary findings suggest that media visibility does not necessarily reflect factors such as prevalence of conditions or the cost of treatment per patient. Read more
FINLAND
Fimea launches online tool for NIS2 compliance checks
19 September 2025
Fimea has introduced a new online tool to help operators determine whether they fall under the scope of the EU’s NIS2 Directive, implemented in Finland through the National Cybersecurity Act (124/2025). In force since 8 April 2025, the law strengthens cybersecurity requirements across the EU, with Fimea’s tool targeting sectors such as medicines and medical device manufacturing, pharmacies, and blood service establishments. Read more
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