5 December 2025
From the regulatory newsfeeds of the Nordic medical product agencies, Arex Advisor has rounded up a selection of highlights from November 2025.
SWEDEN
Sweden tightens rules to improve safety of home-delivered medicines
7 November 2025
The Swedish Medical Products Agency (Läkemedelsverket) has introduced new rules for distance sales to ensure that home delivery of medicines is both simple and safe. The updated requirements set clearer standards for how pharmacies and other authorised retailers may deliver medicines to consumers, strengthening oversight of remote supply. Read more (in Swedish)
SWEDEN
Sweden outlines measures to strengthen community pharmacy preparedness
19 November 2025
The Swedish Medical Products Agency has detailed its work to improve the readiness of community pharmacies, focusing on raising awareness of pharmacies’ roles during crises, heightened preparedness, and wartime. The initiative identifies actions to bolster robustness, continuity, and alternative operating capacity across pharmacy providers. Read more (in Swedish)
NORWAY
NOMA Director appointed Chair of European HTA network
5 November 2025
Trygve Ottersen, Director General of the Norwegian Medical Products Agency, has been elected Chair of the Heads of HTA Agencies Group. His appointment strengthens coordination across Europe’s health technology assessment bodies and supports more aligned evaluation practices. Read more
FINLAND
Fimea seeks expert feedback on high-risk classification for cancer medicines
13 November 2025
Fimea is inviting oncology specialists to comment between 5 and 25 January 2026 on its draft high-risk classification for cancer medicines, developed in collaboration with key stakeholder groups. The preliminary proposals, prepared with experts from Pirkanmaa Wellbeing Services County (Pirha) and Helsinki University Hospital (HUS), aim to strengthen safety oversight and support consistent risk categorisation in cancer care. Read more
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