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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.
