News about Licensing and supervision
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Expression of interest for onsite participation in ACT EU workshop on Decentralised Clinical Trial guidance on October 4th 2022 – Response deadline is September 06th 2022.
| 25 August 2022 |
New and innovative clinical trial designs and methodologiesprovide opportunities and challenges for the EU clinical trials environment. The EU decentralised clinical trials (EU DCT) project aims to address some of these challenges, in line with the European Medicines Agencies Network Strategy to 2025 and European Commission’s Pharmaceutical Strategy for Europe. Since March 2022, the Clinical Trials Coordination Group (CTCG) under the Heads of Medicines Agencies (HMA) have been responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project, with Ditte Zerlang Christensen of the Danish Medicines Agency (DKMA) as the project manager. The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be an onsite meeting hosted by EMA on October 4th 2022. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.
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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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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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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.
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The Danish Medicines Agency can again receive electronic adverse reaction reports via E2B
| 23 November 2020 |
Please be informed that the gateway for SUSAR submission is now available again. If You after 48 hours have submissions that are pending acknowledgements, please contact the Danish Medicines Agency.
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The Danish Medicines Agency cannot receive electronic adverse drug reactions via E2B in the period November 19th from 10:00 CET to November 24th
| 11 November 2020 |
Due to implementation of a new IT-system is it not possible for the Danish Medicines Agency to receive electronic adverse drug reactions (SUSARs) via E2B (DKMAEUDRA) in the period November 19th (10:00 CET) to November 24th 2020. Submissions to EVCTMPROD are not affected.
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Extraordinary measures for clinical trials due to COVID-19
| 09 October 2020 |
UPDATED. We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.