News about Licensing and supervision
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2024 deadline for submitting applications concerning marketing authorisations and clinical trials
| 11 December 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…
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Applications for compassionate use permits on weekdays between Christmas and New Year
| 10 December 2024 |
The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2025. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).
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Deadline for pre-Christmas issue of export certificates for medicinal products: 12 December 2024
| 02 December 2024 |
Applications for export certificates for medicinal products must be received by 12 December 2024 to allow for review and issuance before Christmas.
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Deadline for receipt of applications for company authorisations in 2024: 13 December 2024
| 02 December 2024 |
Applications for company authorisations must reach us by 13 December 2024 for the review to begin before Christmas.
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Common nordic packages for better availability
| 02 December 2024 |
Starting from the new year, a pilot project will introduce English-language common nordic packages. This aims to improve the availability by simplifying production and distribution.
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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 The selected ATC groups will not be published in advance.
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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…
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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…
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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…
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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.