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Danish Medicines Agency releases COVID-19 vaccine batch from quarantine
| 20 October 2023 |
On 17 October, the Danish Medicines Agency decided to quarantine a specific batch (batch HG2252) of COVID-19 vaccines from Pfizer/BioNTech. Since then, the Danish Medicines Agency and Pfizer have worked together to review the documentation of the batch in question, based on which the agency has now decided to release said batch from quarantine.
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Updated status for completion of delayed cases in the licensing area
| 19 October 2023 |
Status for completion of delayed cases in the licensing area as of 1 October 2023 is now updated on the Danish Medicines Agency's website. The Danish Medicines Agency publishes updates on the status
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Covid-19 vaccine batch in quarantine
| 18 October 2023 |
As a precautionary measure, the Danish Medicines Agency has decided to quarantine a specific batch of COVID-19 vaccines from Pfizer/BioNTech in response to vaccine centres having observed a possible error when using a specific vaccine batch. Over the next days, some people will therefore experience having their vaccination appointment cancelled. At present, there are no signs of any impact on the efficacy and safety of the batch in question.
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Invitation to contribute to the upcoming EU multi-stakeholder workshop on clinical trial methodology on 23 November 2023 in Amsterdam
| 13 September 2023 |
As part of the Accelerating Clinical Trials in the EU (ACT EU) programme, you will have the opportunity to participate in the upcoming EU multi-stakeholder workshop on 23 November 2023 in Amsterdam to discuss selected clinical trial methodology topics. Stakeholders are invited to express their interest for participation to the workshop via the EU survey until 17 September 2023.
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Information on transition from NemID to MitID Erhverv
| 15 June 2023 |
DKMAnet is not yet ready to support MitID Erhverv. It is therefore IMPORTANT to keep your NemID employee signature, as it is the only way to access DKMAnet until the transition to MitID Erhverv is completed.
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New criteria for the notification of medicines supply shortages
| 06 June 2023 |
The Danish Medicines Agency has established new criteria for when companies must notify medicines supply shortages. The new criteria make it easier for the companies to know when and for which medicinal products they must notify supply shortages, and a new form has made notification even easier.
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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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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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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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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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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.
