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2022 deadline for submitting applications concerning marketing authorisations and clinical trials
| 19 October 2022 |
The deadline for submitting applications concerning marketing authorisations and clinical trials is 20 December 2022. The Danish Medicines Agency is closed for the Holiday Season, from 24 December, 2022, until 1 January, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before 20 December, 2022. We will consider applications submitted after 20 December, 2022, as if they have been received 2 January 2023.
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Current Danish QRD template to be used in connection with the granting of marketing authorisations
| 11 October 2022 |
Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as w
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Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users
| 30 August 2022 |
Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions in advance (see tabel below) concerning organisation and site registration in OMS.
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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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Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals
| 28 July 2022 |
The last days of June saw the roll out of the 2022 version of the Interpol-managed Operation Pangea XV – a global initiative targeted illegal trade with medicines and medical devices. The Danish Medic
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New Data Ethics Charter provides a framework for the Danish Medicines Agency’s use of health data
| 05 July 2022 |
The Danish Medicines Agency has adopted a Data Ethics Charter consisting of seven principles of data ethics. The charter is to set high ethical standards for the protection and handling of the health data included in the scientific and statistical analytical work performed by the agency.
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The Danish Medicines Agency will be closed on Friday 10 June 2022
| 08 June 2022 |
The Danish Medicines Agency will be holding its staff convention and will be closed on Friday 10 June 2022 However, we process urgent applications for compassionate use permits (applications for d
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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.
