News about Licensing and supervision
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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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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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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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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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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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Announcement of altered dispensing status for gadolinium-containing contrast agents (ATC code: V08CA)
| 22 February 2021 |
The Danish Medicines Agency hereby informs you that the dispensing status for all gadolinium-containing contrast agents, regardless of strength, pack size and indication is changed to ‘BEGR’ (only to be dispensed to hospitals) as of 5 October 2020.
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Clinical trials of the future place the patient at the centre
| 20 January 2021 |
In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.
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Home-based clinical trials will be possible in the future
| 20 January 2021 |
Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.