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Update of product information for veterinary medicinal products in line with version 9 of the QRD template
| 20 December 2023 |
According to Article 152 of Regulation (EU) 2019/6, product information for all veterinary medicinal products granted marketing authorization under Directive 2001/82/EC must comply with version 9 of t
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13 December 2023 is the deadline for our review of export certificates for medicinal products before Christmas
| 28 November 2023 |
Applications for export certificates for medicinal products must reach us by 13 December 2023 to be reviewed and issued before Christmas. Any applications submitted after 21 December will be consid
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Notification of changes in medicine prices and product ranges between Christmas and New Year 2023
| 28 November 2023 |
The Danish Medicines Agency is closed over Christmas and New Year. We will therefore not be offering support in relation to the notification of medicine prices and product ranges from Monday 25 Dece
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Deadline for receipt of applications for company authorisations is 15 December in 2023
| 28 November 2023 |
Your application for a company authorisation must reach us by 15 December 2023 for the review to start before Christmas. Any application received after that will be considered received on 2 January
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Last day for submission of applications for certificates of free sale to export medical devices is 13 December 2023
| 28 November 2023 |
The last day for submitting an application for a certificate of free sale to export a medical device will be Wednesday 13 December 2023. Any application received after that will be considered re
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Deadlines to apply for the issuance of import/export certificates for euphoriant substances before Christmas
| 28 November 2023 |
Applications for import/export certificates received via NDS Web must reach us by 15 December 2023 to be reviewed before Christmas. Applications submitted in any other way must reach us by 8 Decembe
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Danish Medicines Agency closed over Christmas and New Year
| 28 November 2023 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023.
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Applications for compassionate use permits on weekdays between Christmas and New Year
| 28 November 2023 |
The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2024. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).
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2023 deadline for submitting applications concerning marketing authorisations and clinical trials
| 13 November 2023 |
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2023. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2023, until January 1, 2024, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2023. We will consider applications submitted after December 20, 2023, as they have been received January 2, 2024.
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First electronic product information published for medicines
| 09 November 2023 |
Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU.
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More reports at the beginning of the vaccination programme, but no suspicion of safety differences between COVID-19 vaccine batches
| 01 November 2023 |
A new analysis from the Danish Medicines Agency shows that the number of reports of suspected side effects after vaccination with COVID-19 vaccines is highly related to the time the individual vaccine batches were used.
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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.
