News about Licensing and supervision
-
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
-
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
-
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
-
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
-
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).
-
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.
-
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
-
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.
-
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.
-
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.
-
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.
-
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.