News
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EMA is introducing Multi-Factor Authentication (MFA) for the Clinical Trial Information System (CTIS) from 01 June 2023.
| 30 May 2023 |
Multi-factor (MFA) authentication for user logins to Clinical Trial Information Systems (CTIS), for both Sponsor and Member State workspaces, will be launched on 1 June 2023.
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Henvendelser til Lægemiddelstyrelsen om status på indsendte ansøgninger for lægemidler godkendt via DCP, MRP eller national procedure
| 26 May 2023 |
Henvendelser til Lægemiddelstyrelsen om status på indsendte ansøgninger for lægemidler godkendt via DCP, MRP eller national procedure
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Registration of QPPV and PSMF number for veterinary medicinal products
| 15 March 2023 |
Under Commission Implementing Regulation EU 202116 of 8 January 2021, all Marketing Authorisation Holders of Veterinary Medicinal products in the EU, must register information on Qualified Persons for Pharmacovigilance QPPV and Pharmacovigilance System Master File PSMF in the Union Product Database UPD.
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The Danish Medicines Agency suspends the Danish marketing authorisations of four generic medicines
| 15 March 2023 |
The European Commission has reached a decision in the case about the bioequivalence company Synchron Research, deciding that a number of generic medicines must be suspended in the EU counties where they are authorised. The Danish Medicines Agency therefore suspends the marketing authorisations of four medicines.
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Multi-stakeholder platform to improve clinical trials in the EU – Public consultation
| 07 February 2023 |
As part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) are establishing a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform will support discussions across the clinical research landscape and facilitate the evolution of clinical trial methods and approaches.
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Recall of the antibiotic Dicillin from Sandoz
| 07 February 2023 |
Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine.
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Order books and Procedure Start Table
| 12 January 2023 |
In order to improve the companies' possibility to follow the status of their submitted variations, the Danish Medicines Agency is expanding its order book for variations to include all national type I
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Updating of summaries of product characteristics due to changed ATC codes for 2023
| 02 January 2023 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2023.
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Applications for compassionate use permits on weekdays between Christmas and New Year
| 02 December 2022 |
The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 2 January 2023. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).
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The deadline for receipt of applications for company authorisations is 22 December in 2022
| 02 December 2022 |
Applications for company authorisations will be received no later than December 22, 2022. Applications received after this date will be considered received on January 2, 2023. Fee rates and exceptio
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Deadline for applications for export certificates for medicines in 2022
| 02 December 2022 |
Applications for export certificates for medicines must be received by 14 December 2022 at the latest if they are to be processed before Christmas. Applications submitted after 22 December will be c
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Deadline for submission of applications for medical device export certificates in 2022
| 02 December 2022 |
The last day for submitting an application for a medical device export certificate will be 14 December 2022. Any application received after that will be considered received on 1 January 2023.
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Deadlines to apply for the issuance of import or export certificates for euphoriant substances before Christmas
| 02 December 2022 |
Applications for import/export certificates submitted via NDS Web must reach us by 16 December 2022 to be reviewed before Christmas.
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Notification of medicine price and assortment changes between Christmas and New Year
| 02 December 2022 |
The Danish Medicines Agency is closed between Christmas and New Year. This means that there is no support regarding notification of medicine price and assortment changes from Monday 26 December 2022 to and including 30 December 2022.
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Change of practice for the Danish Medicines Agency’s inspections
| 04 November 2022 |
The Danish Medicines Agency is now implementing the digital signing system called Penneo. As of 1 November 2022, we will be using digital signatures to sign all inspection reports.
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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