News about Licensing and supervision
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All Danish Wholesale Distribution Authorisations now appear from EudraGMDP
| 16 September 2016 |
All Danish Wholesale Distribution Authorisations have been updated to the applicable European format and entered into the common EU database, EudraGMDP, which is available to the general public.
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New Danish member of the CHMP
| 06 September 2016 |
Sinan B. Sarac, Medical Doctor, is Denmark's new member of the CHMP, the European Medicines Agency's committee for the authorisation of medicines for human use.
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Improved access to patient data in clinical trials for monitors and GCP inspectors
| 05 September 2016 |
The Danish Medicines Agency's inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.
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More clinical trials in Denmark
| 09 August 2016 |
Last year, the Danish Medicines Agency received 329 applications for authorisation of clinical trials of medicines in humans – 45 applications more than in 2014. The figures appear from the Danish Medicines Agency’s annual report on clinical trials.
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Medicines tested by Semler are no longer sold in Denmark
| 04 August 2016 |
Medicines authorised on the basis of studies conducted by Semler are no longer sold on the Danish market.
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Marketing authorisation for medicine for cows suspended in the EU/EEA
| 20 July 2016 |
On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.
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Clinical trial guidelines in public consultation
| 28 June 2016 |
As a result of the EU's new clinical trial regulation, the European Commission has submitted four guidelines for public consultation.
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New rules governing medicine packages
| 27 June 2016 |
The Danish Medicines Agency has amended the guideline on variations to marketing authorisations and the executive order on product numbers for medicinal products.
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Use of medicine for cows suspended
| 21 June 2016 |
Today, the Danish Medicines Agency has decided to suspend the use of the veterinary medicine Velactis, which is used to reduce milk production (drying-off) in dairy cows.
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Operation targets illegal medicines
| 10 June 2016 |
Global medicine operation just completed. Operation Pangea resulted in 393 arrests and the suspension of more than 4,900 websites.
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Beware of falsified medicines
| 08 June 2016 |
Today, 8 June 2016, is the World Anti-Counterfeiting Day. The Danish Medicines Agency participates in this campaign to draw attention to the problem of illegal sale of falsified medicines.
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New Danish act on clinical trials
| 25 May 2016 |
The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new research ethics committees will be established. However, the act does not come into force until 2018.
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New comprehensive list of euphoriant substances regulated in Denmark
| 26 February 2016 |
You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.
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Form for notification of invoice details concerning clinical trials discontinued
| 23 February 2016 |
The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.
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Twelve new substances on the list of euphoriant substances
| 17 February 2016 |
As of 18 February 2016, 12 new substances are included in the Danish executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.
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Access to results in EudraCT from 13 January
| 13 January 2016 |
When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.
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New clinical trial regulation under way
| 12 January 2016 |
New EU Clinical Trial Regulation has been postponed until 2018
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Updating of summaries of product characteristics due to changed ATC codes for 2016
| 07 January 2016 |
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 2016.
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The Danish Medicines Agency has a new website
| 04 January 2016 |
Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.
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Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications
| 09 July 2013 |
The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.