News 2026
01 January 2026
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Lægemiddelstyrelsens whistleblowerordning i perioden 1. januar 2025 til 31. december 2025 (offentlighedsordning)
| 23 January 2026 |
Det følger af whistleblowerloven, at myndigheder omfattet af reglerne om aktindsigt i offentlighedsloven mindst én gang årligt skal offentliggøre oplysninger om deres virksomhed efter whistleblowerloven. Der er herved tale om en såkaldt 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.