News
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New executive order raises fees in the area of the Danish Medicines Agency
| 03 May 2022 |
Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.
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Management of clinical trials in light of the current situation in Ukraine
| 06 April 2022 |
The current situation in Ukraine can have an impact on the conduct of clinical trials. It can affect both the supply of trial-related drug products and the collection of critical data. Therefore, an initial guidance on the management of clinical trials in light of the situation have been issued by the European Commission (EC), the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTCG).
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Danish Medicines Agency presents new strategy
| 05 April 2022 |
Lars Bo Nielsen, Director General of the Danish Medicines Agency, announces new 2022-26 strategy for the agency. The strategy supports the Danish Ministry of Health’s joint corporate strategy and emphasises a vision to lead national and international collaboration, for example regarding better use of data and new technology and dialogue with public and society in general.
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Crisis in Ukraine may impact review times and the prioritisation of cases
| 07 March 2022 |
As a result of the crisis in Ukraine, the Danish Medicines Agency performs tasks relating to the supply of medicines to the Danish market.
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Assessment of new names of authorised veterinary medicines under the new veterinary regulation
| 22 February 2022 |
The assessment of names for already authorised veterinary medicines must be approved by the Danish Medicines Agency before the submission of a variation application.
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Clarification of labelling practice for warning statements on human medicines
| 05 January 2022 |
During our review of applications for marketing authorisations for human medicines and variations to marketing authorisations, we have noted uncertainty about the labelling practice regarding the warning statements of schedule 2 of the Danish executive order on labelling. The question is whether these warnings are required on the packaging and in the package leaflet if the warning statements are not supported by the summary of product characteristics (SPC) of the medicinal product concerned. We therefore find it necessary to clarify the labelling practice for warning statements on human medicines.
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Notification of medicine price and assortment changes between Christmas and New Year
| 15 December 2021 |
The Danish Medicines Agency is closed between Christmas and New Year, from Friday 24 December 2021 to Sunday 2 January 2022 - both days inclusive. However, the Danish Medicines Agency provides suppo
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The deadline for receipt of applications for company authorisations is 22 December in 2021
| 15 December 2021 |
Your application for a company authorisation must be received by 22 December 2021. Any application received after that will be considered received on 3 January 2022. Any application subject to a fee
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Deadline for applications for export certificates for medicines in 2021
| 15 December 2021 |
Applications for export certificates for medicines that we receive on or before 14 December will be handled, and certificates issued, on or before 23 December. Any request for an export certificate
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Applications for compassionate use permits on weekdays between Christmas and New Year
| 15 December 2021 |
The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 3 January 2022. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).
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Danish Medicines Agency closed over Christmas and New Year
| 15 December 2021 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Friday 24 December 2021 to Sunday 2 January 2022, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2021.
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Deadline for submission of applications for medical device export certificates in 2021
| 14 December 2021 |
The last day for submitting an application for a medical device export certificate will be 15 December 2021. Any application received after that will be considered received on 3 January 2022.
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EMA is evaluating Moderna’s COVID-19 vaccine for children aged 6 to 11
| 12 November 2021 |
Moderna has submitted an application to the European Medicines Agency, EMA, to extend its conditional authorisation for its COVID-19 vaccine, Spikewax, to children aged 6 to 11.
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2021 deadline for submitting applications concerning marketing authorisations and clinical trials
| 08 November 2021 |
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20 th The Danish Medicines Agency is closed for the Holiday Season, from December 24
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The Danish Medicines Agency's guideline on extraordinary measures for clinical trials due to COVID-19 will not be extended after 01 December 2021
| 04 November 2021 |
We have chosen not to extend the validity of our guidance on extraordinary measures for clinical trials due to COVID-19 further, why the guidance and the granted exemptions expire on 01 December 2021.
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No evidence that menstrual disorders are triggered by COVID-19 vaccination
| 24 September 2021 |
The Danish Medicines Agency and the European Medicines Agency have reviewed cases of menstrual disorders reported as side effects after COVID-19 vaccination and have found no causal association.
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Updated guidance on the implementation of decentralised elements in clinical trials with medicinal products
| 10 September 2021 |
You can now read the updated guidance on the implementation of decentralised elements in clinical trials with medicinal products - version 2.0
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The uploading of package leaflets via DKMAnet is closed in the period from September 10 to September 14
| 09 September 2021 |
As previously announced, there have been errors in the display of company names and marketing authorisation status for certain medicines on www.indlaegsseddel.dk . The Danish Medicines Agency is no
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Status på behandlede indberetninger om formodede bivirkninger ved Vaxzevria (AstraZeneca), uge 36
| 09 September 2021 |
Lægemiddelstyrelsen har behandlet i alt 3.879 indberetninger om formodede bivirkninger ved Vaxzevria (AstraZenecas COVID-19-vaccine). De fleste er kendte og forbigående bivirkninger. Der er behandlet 11 tilfælde af anafylaksi. Tre tilfælde af det usædvanlige sygdomsbillede med lavt antal blodplader, blodpropper samt blødning vurderes at være relateret til vaccinen.
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