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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.
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Members for the Medicinal Products Committee
| 02 June 2021 |
The Danish Medicines Agency invites interested parties to nominate members to the Medicinal Products Committee for the term of 1 October 2021 to 30 September 2025. Anyone can nominate members to the Medicinal Products Committee, and self-nomination is also possible.
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New EU rules on medical devices set to strengthen patient safety
| 26 May 2021 |
Today new EU rules on medical devices enter into force. The new rules aim to strengthen patient safety and ensure that patients can benefit from new innovative devices. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment.
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Dean of Aarhus University to join the Danish Medicines Agency as new Director General
| 26 May 2021 |
The Ministry of Health has appointed Lars Bo Nielsen, Dean at Aarhus University, as Director General of the Danish Medicines Agency. Lars Bo Nielsen is a qualified doctor and has extensive leadership experience within both the health and science areas.
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Danes know how vaccines work, but they underestimate how common mild side effects are
| 25 May 2021 |
A new population survey shows that Danes are generally well-informed when it comes to how COVID-19 vaccines prevent the disease. But almost half of Danes underestimate how many get mild, transient side effects, such as fever, after their COVID-19 vaccination.
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More than one in two young people say the COVID-19 vaccine debate is characterised by misinformation
| 25 May 2021 |
In a new survey, more than half of the 16 to 34-year-olds find that the vaccine debate is characterised by misinformation, and that the tone is negative. The Danish Medicines Agency is now stepping up its ‘think before you share campaign’ (#TænkFørDuDeler) – a campaign encouraging people to check facts and to respect other people on social media.
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New survey: Four in ten Danes would contact their doctor if they develop fever after COVID-19 vaccination
| 25 May 2021 |
Almost four in ten Danes say in a population survey that they would contact their doctor if they develop fever as a side effect after the COVID-19 vaccine jab. Theoretically, this corresponds to up to half a million Danes when everyone has been fully vaccinated.
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Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available
| 04 May 2021 |
Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.
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Annual report of the Danish Medicines Agency: The COVID-19 pandemic had a considerable impact on our work in 2020.
| 26 April 2021 |
The year 2020 was a year like no other at the Danish Medicines Agency. Both internally and externally, the handling of COVID-19 had a decisive impact on much of our work. However, we managed to retain our European position and to carry through an important reinforcement of our IT landscape, so concludes the Danish Medicines Agency’s annual report for 2020.
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EMA: Possible link between the Johnson & Johnson vaccine and unusual symptoms
| 21 April 2021 |
There is a possible link between the Johnson & Johnson vaccine and unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding. A few cases have been observed in the USA. The frequency of these unusual symptoms is still being investigated.
