Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines
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The Danish Medicines Agency will be closed on Friday 10 May 2024
| 30 April 2024 |
The Danish Medicines Agency will be closed on Friday 10 May, the day after Ascension Day. However, we process urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines produced by a pharmaceutical company).
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Status for the project regarding the control of anti-tampering devices (ATD) on medicinal product packages
| 25 April 2024 |
Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory is currently working on a project to check the anti-tampering device (ATD) on selected medicinal product packages. Approx. 10% of the packages requisitioned so far 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 to test their ATDs to avoid unauthorised access to the medicinal products.
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Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
| 11 March 2024 |
Give your valuable feedback to the European Pharmacopoeia (Ph. Eur.) in the field of setting standards for therapeutic mAbs. The survey will take about 20 minutes. Please complete the survey by
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Continued control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet
| 01 February 2024 |
The Danish Medicines Agency’s Department for Control and Security of Supply resumes the work of checking whether readable leaflets have been uploaded to www.indlaegsseddel.dk
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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.