News 2026
01 January 2026
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New functionalities in the CTIS-module Non-substantial modification
| 09 February 2026 |
It is now possible to submit non-substantial modifications, where it earlier required submission of a substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities below and on our homepage.
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Electronic dispatch of decision letters marks its fifth anniversary
| 04 February 2026 |
Since 1 February 2021, the Danish Medicines Agency has been issuing decision letters on applications for marketing authorisations electronically and securely.