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New CMDv Guidance on the Submission of G.I.18 Variations
| 12 June 2024 |
CMDv has published guidance on the submission of G.I.18 variations requiring assessment. The Danish Medicines Agency requests that all Marketing Authorisation Holders (MAHs) carefully review the principles in this document to ensure the process of submitting and obtaining approval of a G.I.18 variation is as efficient and smooth as possible.
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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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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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Danish Medicines Agency establishes that chronic urticaria could be a side effect of the Spikevax vaccine
| 05 April 2024 |
The European Pharmacovigilance Risk Assessment Committee (PRAC) has reassessed if chronic urticaria could be a side effect after vaccination with the Spikevax vaccine from Moderna. This follows a review from the Danish Medicines Agency, which has investigated data and reports from patients across the European countries.
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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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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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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.
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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.
