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Whistleblowing scheme of the Danish Medicines Agency from 1 January 2025 to 31 December 2025 (system of openness)
| 27 January 2026 |
The Danish Whistleblower Act obliges authorities that are subject to the rules of the Access to Public Administration Files Act to publish, at least once a year, information on the activities they have carried out under the Danish Whistleblower Act – a so-called system of openness (offentlighedsordning).
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Expedited Assessment of Clinical Trials in the EU: FAST‑EU Pilot Project Begins on 30 January 2026
| 23 January 2026 |
The sponsor guideline is now available.
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The GMDP-inspection focus for 2026
| 23 January 2026 |
Compliance with dossier requirements GMP inspections. In 2026, the Danish Medicines Agency will have a special focus on whether GMP companies comply with the requirements laid down in the dossiers o
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Updating of summaries of product characteristics due to changed ATC codes for 2026
| 05 January 2026 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2026.
