Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines
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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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Danish Medicines Agency closed over Christmas and New Year
| 10 December 2024 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Tuesday 24 December 2024 to Wednesday 1 January 2025, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2024.
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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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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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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.