News about Licensing and supervision
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The Danish Medicines Agency will be closed on Friday 15 May 2026
| 07 May 2026 |
The Danish Medicines Agency will be closed on Friday 15 May, the day after Ascension Day. However, we process urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines produced by a pharmaceutical company).
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Operation Pangea XVIII: Global action against falsified medicines and illicit trade
| 07 May 2026 |
The Danish Medicines Agency has reported 6 websites to the police as part of the INTERPOL operation, Operation Pangea XVIII, and the Danish Customs Agency has detained 19 consignments containing illicit medicines, narcotics and doping substances.
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For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
| 06 March 2026 |
See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs
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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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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.