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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.
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EU one step closer to electronic product information
| 16 January 2025 |
In 2023-2024, the Danish Medicines Agency participated in a pilot set to pave the way for using electronic product information (ePI) in favour of the printed package leaflets provided in the medicine package and the printed product information for healthcare professionals.
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Updating of summaries of product characteristics due to changed ATC codes for 2025
| 02 January 2025 |
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 2025.
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2024 deadline for submitting applications concerning marketing authorisations and clinical trials
| 11 December 2024 |
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2024. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2024, until January 1, 2025, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2024. We will consider applications submitted after December 20, 2024, as they have been received January 2, 2025. For applications concerning clinical trials applied under the Clinical Trials Regulation no assessment will be performed during the winter clock stop between 23 December 2024 and 7 January 2025, both days included. The deadline for these trials is postponed.
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Application deadlines for the issuance of import/export certificates for euphoriant substances before Christmas
| 10 December 2024 |
Applications for import/export certificates received via NDS Web must reach us by 16 December 2024 for review before Christmas.
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Applications for compassionate use permits on weekdays between Christmas and New Year
| 10 December 2024 |
The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2025. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).
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Nyt lægemiddel tilføjet listen over kritiske lægemidler med forsyningsproblemer
| 09 December 2024 |
Til medicinalvirksomheder: Der er tilføjet et lægemiddel til listen over kritiske lægemidler med forsyningsproblemer, hvor Lægemiddelstyrelsen opfordrer virksomheder til at ansøge om markedsføring
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Last day for submission of applications for certificates of free sale to export medical devices is 11 December 2024
| 09 December 2024 |
The last day for submitting an application for a certificate of free sale to export a medical device will be Wednesday 11 December 2024. Any application received after that will be considered re
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Deadline for pre-Christmas issue of export certificates for medicinal products: 12 December 2024
| 02 December 2024 |
Applications for export certificates for medicinal products must be received by 12 December 2024 to allow for review and issuance before Christmas.
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Deadline for receipt of applications for company authorisations in 2024: 13 December 2024
| 02 December 2024 |
Applications for company authorisations must reach us by 13 December 2024 for the review to begin before Christmas.
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Notification of changes in medicine prices and product ranges between Christmas and New Year 2024, as well as access to preliminary information for subscribers to Erhverv Medicinpriser
| 02 December 2024 |
The Danish Medicines Agency will be closed between Christmas and New Year. This means there will be no support available regarding the notification of changes to medicine prices and assortments from
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Common nordic packages for better availability
| 02 December 2024 |
Starting from the new year, a pilot project will introduce English-language common nordic packages. This aims to improve the availability by simplifying production and distribution.
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Control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet
| 15 November 2024 |
The Danish Medicines Agency's laboratory will regularly select ATC groups and check whether readable package leaflets have been uploaded to www.indlaegsseddel.dk. The selected ATC groups will not be published in advance.
