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Fra 1. september 2025 vil Lægemiddelstyrelsen anmode om at modtage bioækvivalensdata i CDISC-format
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format Based on a pilot study conducted by the Danish Medicines Agency during 2023 an
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Combined studies with a clinical trial and a performance study: Sponsors now have the opportunity to apply for approval through a national coordinated application process
The Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline on a national coordinated application process for combined studies with a cl
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GCP inspection updates
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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Deadline for pre-Christmas issue of export certificates for medicinal products: 12 December 2025
Applications for export certificates for medicinal products must be received by 12 December 2025 to allow for review and issuance before Christmas.
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Application deadlines for the issuance of import/export certificates for euphoriant substances before Christmas
Applications for import/export certificates received via NDS Web must reach us by 16 December 2025 for review before Christmas. Applications submitted by any other means must reach us by 9 December 2025 for review before Christmas.
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Deadline for receipt of applications for company authorisations: 15 December 2025
Applications for company authorisations must reach us by 15 December 2025 for the review to begin before Christmas.
