News about Licensing and supervision
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Control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet
| 15 November 2024 |
The Danish Medicines Agency's laboratory will regularly select ATC groups and check whether readable package leaflets have been uploaded to www.indlaegsseddel.dk. The selected ATC groups will not be published in advance.
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2024 deadline for submitting applications concerning marketing authorisations and clinical trials
| 05 November 2024 |
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2024. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2024, until January 1, 2025, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2024. We will consider applications submitted after December 20, 2024, as they have been received January 2, 2025. For applications concerning clinical trials applied under the Clinical Trials Regulation no assessment will be performed during the winter clock stop between 23 December 2024 and 7 January 2025, both days included. The deadline for these trials is postponed.
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Completion of the project regarding the control of anti-tampering devices (ATD) on medicinal product packages
| 12 September 2024 |
The Danish Medicines Agency's laboratory has completed a project in which the anti-tampering device (ATD) on random samples of selected medicinal product packages has been checked. Approx. 10% of the packages requisitioned had an ATD that did not work. The flawed devices are designed as a sticker, that can be removed without it being visible on the packaging. We encourage marketing authorisation holders (MAH) to test their ATDs to prevent unauthorised access to the medicinal products without tamper evidence.
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Call for Applications for Marketing Authorizations for Critical Medicines
| 22 August 2024 |
The Danish Medicines Agency is making a call for companies to apply for marketing authorizations for selected critical medicines. This initiative aims to ensure the supply of essential medicines in De
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Control of companies' upload of package leaflets to the Danish Medicines Agency's portal DKMAnet
| 01 August 2024 |
Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory carries out regular control of companies’ upload of package leaflets to the Danish Medicines Agency’s portal DKMAnet (www.indlaegsseddel.dk). The control ensures, that users of medicinal products have access to an electronic package leaflet, if the physical package leaflet is not available. We check: • Whether the package leaflet is uploaded? • Whether the package leaflet is printable? • Whether the package leaflet is readable when printed out? • Whether the electronic package leaflet contains a date of latest revision? A control project was recently completed for ATC codes R01, S01-03. 5% of the uploaded package leaflets were flawed and the marketing authorization holders involved are in the process of correcting the errors. In general, we encourage marketing authorization holders to test whether the uploaded package leaflets are readable when printed to ensure user-friendliness. We made 241 searches on “Indlaegsseddel.dk” for ATC codes R01 and S01-03, which cover medicinal products for diseases of the nasal cavity and eye and ear diseases. In particular, we observed that the font size of several package leaflets was smaller than point 9 according to the Readability Guideline.
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New regulations on Stockpiling of Critical Medicines effective on July 1 2024
| 01 July 2024 |
It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.
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Tidsfrister & CTIS: Tidsfrister for kliniske forsøg skal overvåges i CTIS og forordningsforsøg skal overføres til CTIS
| 10 June 2024 |
Læs mere om CTIS timetable med tidsfrister for kliniske forsøg samt tidsfrister for overførsel til CTIS af forsøg der er opstartet under forordningen. Alle kliniske forsøg der skal fortsætte efter 30 januar 2025 skal overføres til CTIS.
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Regulatory training on transitional trials in CTIS with open question and answers session
| 13 February 2024 |
EMA has organized in the series of the CTIS Bitesize Talk an event related to the transitional trial in CTIS Thursday, 29 February 2024, 16:30 (CET) - 18:00 (CET).
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ACT EU Training for non-commercial sponsors. Transitioning trials to the CTR
| 02 February 2024 |
ACT EU training for non-commercial sponsors Friday, 09 February 2024, from 10:00 AM (CET) to 1:00 PM (CET). The event will be live broadcast and no registration is required to follow the live broadcast on EMA’s website.
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Updating of summaries of product characteristics due to changed ATC codes for 2024
| 02 January 2024 |
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 2024.
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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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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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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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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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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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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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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.