News
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Reassessment of reimbursement status for medicinal products for hypertension
| 18 December 2006 |
In March 2006, the Danish Medicines Agency contacted a number of scientific societies to clarify certain aspects of the treatment of hypertension in Denmark.
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Reassessment of subgroups in ATC group C
| 24 April 2006 |
The Danish Medicines Agency is just beginning to reassess the subgroups in ATC group C, medicinal products for the cardiovascular system, and for the first three months of 2006 the agency expects to be working with the following six subgroups.
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Letter to scientific societies on treatment of hypertension
| 24 April 2006 |
As part of the reassessment concerning medicinal products' reimbursement status, the Danish Medicines Agency has begun looking at reimbursement status of medicinal products for hypertension.
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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.
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Bevilling til Brædstrup Apotek
Lægemiddelstyrelsen har den 12. september 2018 meddelt Kerly Maire Servilieri bevilling til at drive Brædstrup Apotek.
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Danish Medicines Agency shortens the review time for applications for COVID-19 medicine trials
Drug regulatory authorities around the world are taking several steps to speed up the development and availability of medicines to treat and prevent novel COVID-19. The Danish Medicines Agency in Denmark has just implemented an emergency procedure for applications for clinical trials with human subjects.
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EMA: No evidence linking ibuprofen to worsening of COVID-19
The press and social media have raised questions about whether ibuprofen could worsen the condition of patients infected with COVID-19. The European Medicines Agency reports that there is currently no scientific evidence to suggest this. The Data Analytics Center of the Danish Medicines Agency now launches an ultra-quick study.
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Henstilling om, hvordan præparatet remdesivir skal bruges til behandling af COVID-19 i såkaldt compassionate use-programs i EU
Under et ekstraordinært møde, der blev afholdt den 2. april 2020, gav det europæiske medicinalagentur EMA's humane lægemiddeludvalg (CHMP) henstillinger om, hvordan præparatet remdesivir skal bruges til behandling af COVID-19 i såkaldt compassionate use-programs i EU, dvs. via udleveringstilladelser.
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COVID-19: Restriction on OTC medicines lifted
The Danish Medicines Agency lifts the restriction on over-the-counter (OTC), which has been in force since March. This means that pharmacies, supermarkets, kiosks and others with permission to sell OTC medicines can resume selling more than one pack of the same type of OTC medicine per customer.
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EMA recommends conditional authorisation of the COVID-19 vaccine from Moderna
The European Medicines Agency, EMA, has recommended the European Commission to grant a conditional authorisation for the COVID-19 vaccine for use throughout the European Union, including Denmark.
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European Commission authorises one more COVID-19 vaccine
On 6 January 2021, the European Commission granted a conditional marketing authorisation for the COVID-19 vaccine from Moderna. The vaccine has demonstrated a 94 per cent efficacy in trials. The authorisation is valid throughout the European Union including Denmark.
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Thomas Senderovitz leaves the Danish Medicines Agency
Thomas Senderovitz has announced that he is leaving his role as Director General of the Danish Medicines Agency to pursue fresh opportunities.