News about Licensing and supervision
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Zinc oxide for young pigs to be phased out
| 19 December 2016 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.
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Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products
| 12 December 2016 |
Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.
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Twelve new substances on the list of euphoriant substances
| 30 November 2016 |
As of 24 November 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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Available time slots for DCP applications with Denmark as reference member state
| 28 October 2016 |
Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available.
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Experts for the European Pharmacopoeia's groups of experts and working parties
| 07 October 2016 |
A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.
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Manufacturers and wholesale distributors must be contactable outside opening hours
| 22 September 2016 |
The Danish Medicines Agency will make calls to companies' main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.
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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.