Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines
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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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PRAC assesses that NAION could be a very rare side effect of Ozempic, Rybelsus and Wegovy
| 19 March 2026 |
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends that the product information for semaglutide medicines should include information that the rare eye condition NAION could be a very rare side effect. Treatment should be stopped if symptoms of NAION occur.
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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.
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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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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.