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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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Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination
| 26 August 2021 |
In collaboration with the EMA, the Danish Medicines Agency is investigating whether the rare inflammatory condition of MIS-C, previously observed as an aftereffect of COVID-19 infection in children and adolescents, can also occur after vaccination. While no causality with the vaccine has been established, it cannot be excluded either.
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Error in company names and marketing status at www.indlaegsseddel.dk
| 10 August 2021 |
The Danish Medicines Agency is aware that an incorrect company name and marketing status are shown for some medicines at www.indlaegsseddel.dk.
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New campaign aimed at doctors: High-quality ADR reports make a difference
| 09 July 2021 |
The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.
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Nine million packages of illegally sold medicines and medical devices seized in Operation Pangea
| 09 June 2021 |
This year’s global Interpol action Operation Pangea focused particularly on the illegal sale of medicines and medical devices related to COVID-19. In Denmark, the Danish Medicines Agency identified and reported 46 websites engaged in illicit sale of medicines and medical devices.
