News
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Last day for submission of applications for certificates of free sale to export medical devices is 12 December 2025
| 28 November 2025 |
The last day for submitting an application for a certificate of free sale to export a medical device will be Friday 12 December 2025. Any application received after that will be considered recei
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Important Information Regarding Medicine Price and Product Range Changes Between Christmas and New Year 2025
| 25 November 2025 |
The Danish Medicines Agency will be closed from Wednesday, 24 December 2025, through Thursday, 1 January 2026. During this period, no support will be provided in connection with the submission of pric
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Danish Medicines Agency strengthens its organisational foundation to prepare for tomorrow's tasks
| 11 November 2025 |
As of 1 January 2026, a new structure will facilitate cross-disciplinary collaboration and prepare the agency for tomorrow’s tasks within especially four strategic areas. The new structure is also welcoming a new division for preparedness and supply.
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2025 deadline for submitting applications concerning marketing authorisations and clinical trials
| 03 November 2025 |
The Danish Medicines Agency is closed for the Holiday Season, from December 24, 2025, until January 1, 2026, both days included.
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Interactive map of clinical trials in the EU now available in all EU languages
| 29 October 2025 |
The interactive map provides patients, healthcare professionals and everyone else with easy access to current information about clinical trials conducted throughout the EU, Norway and Iceland, and it has just been made available in all EU languages.
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Changes to the Cannabis Flower Monograph – Now Open for Public Consultation
| 11 September 2025 |
The European Pharmacopoeia is currently updating the monograph for Cannabis Flower. The proposed changes are now available for public consultation in Pharmeuropa Online, Issue 37.4. Deadline for comments: 31 December 2025
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Electronic leaflets for veterinary medicinal products have too small font size
| 04 September 2025 |
The Danish Medicines Agency monitors the readability of the electronic leaflets uploaded to DKMAnet. This is done by taking samples from the marked. The leaflets are printed out and the readability is assessed. It is important that you are able to find information about your medicine in the Package Leaflet at any time, even if the package leaflet from your medicine pack is lost. At the moment, we sample leaflets for veterinary medicinal products. In these samples we have found that many leaflets have too small font size when printed.
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GCP inspection updates
| 02 September 2025 |
Please note that the GCP inspection has updated information provided on the website. The updates vary in scope, but texts have been adapted to Regulation (EU) no 536/2014 and Guideline ICH E6 R3
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Beware of websites and social medial posts misusing the Danish Medi-cines Agency logo
| 21 August 2025 |
Falsified and illegal products are increasingly being promoted on social media and websites that have no authority whatsoever to sell medicines and medical devices. Consumers risk being deceived due to the misuse of the Danish Medicines Agency logo or that of other authorities.
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Revised CTIS Sponsor Handbook release
| 07 July 2025 |
The revised Sponsor Handbook for the Clinical Trials Information System (CTIS) will be published on the EMA website on Wednesday 9 July 2025. On the same day, a dedicated CTIS bite-size talk takes place at 15:30 CEST.
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The Danish Medicines Agency requires bioequivalence data in a better data format
| 03 July 2025 |
In future, the Danish Medicines Agency will request that data from bioequivalence studies be submitted in an additional data format to that used today. Businesses applying for approval of new medicines or submitting variation applications will be required to submit data in CDISC format from 1 September 2025.
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Call for interest launched for COMBINE pilot exploring the feasibility of coordinated assessment across EU Member States for combined studies
| 16 June 2025 |
Call for interest for COMBINE pilot is now launched in COMBINE project 1 and the sponsors of combined studies are encouraged to express their interest to participate. A webinar for interested sponsors will be hosted 20 June 2025, 2-4pm CEST. Please find details on the webinar, eligibility criteria and pilot process on the European Commission COMBINE Project 1 dedicated subpage: COMBINE Project 1 – pilot “all-in-one” coordinated assessment - European Commission.
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First common Nordic packages in English approved
| 20 March 2025 |
The first two common Nordic medicinal products with texts in English have just been approved for use in all Nordic countries, following a pilot that was launched to make the small Nordic markets more attractive and to improve the supply of important medicines.
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Live streaming of the Danish Medicines Agency's after-work meetings on the revised ICH GCP guideline (ICH E6 R3)
| 06 March 2025 |
The Danish Medicines Agency will hold after-work meetings on the revised ICH GCP guideline (ICH E6 R3) on February 27 and 28, 2025, from 14:30 to 18:00. The meetings will be conducted by ICH E6 R3 EWG member and GCP inspector Lisbeth Bregnhøj. You can find the links for streaming in this news.
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Update: Information meeting on the revised ICH GCP guideline (ICH E6 R3)
| 06 March 2025 |
The Danish Medicines Agency will hold after-work meetings on the revised ICH GCP guideline (ICH E6 R3) on February 27 and 28, 2025, from 14:30 to 18:00.
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Remember to Enter Start Dates in CTIS
| 19 February 2025 |
This is a technical necessity to ensure that the trial, and thus the approval, does not expire.
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New Protocol Template for Clinical Trials
| 06 February 2025 |
We have updated our protocol template to include even more guidance from both the Danish Research Ethics Committees and the Danish Medicines Agency. By starting out from this improved protocol template it can to a higher degree be assured that the regulatory demands to the protocol are met – and hopefully the process of developing the protocol is made easier and better.
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ICH GCP training – what are the expectations?
| 23 January 2025 |
ICH E6 revision 3 has now been published. The Danish Medicines Agency anticipate questions regarding the need for training and retraining and therefore publish this Q&A.
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Pharmaceutical companies must ensure that the labelling on the medicine packages cannot disappear
| 22 January 2025 |
When patients take medicine home, it is important that the text on the package does not fade or rub off when the patient have the package in their hands. The Danish Medicines Agency continu-ously tests whether the printed text meets the requirement that the labelling must be indelible. Find the Danish Medicines Agency's test method here.
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Suspicion of rare eye condition from Ozempic use to be investigated further
| 17 January 2025 |
The Danish Medicines Agency will request the European Pharmacovigilance Risk Assessment Commit-tee, PRAC, to assess two new Danish register-based studies from the University of Southern Denmark. The studies point to a potential increased risk of a rare eye condition, NAION, in patients receiving the diabetes medicine Ozempic.