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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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The Danish Medicines Agency to strengthen its leadership and professional focus
| 28 September 2016 |
A new division with medical expertise and a general strengthening of the leadership throughout the Agency. This is the essence of the organisational change which will take effect in the Danish Medicines Agency at the turn of the year.
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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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Danish Pharmacovigilance Update, August 2016
| 13 September 2016 |
The August issue of Danish Pharmacovigilance Update.
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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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An impact on the European agenda
| 15 August 2016 |
In five short videos, we describe how we work with safety for Danish medicine users at the Danish Medicines Agency. The work extends far beyond the borders of Denmark when we assess whether to authorise new medicines and whether the side effects of a medicine are too serious in relation to its efficacy.
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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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Efficacy of emergency contraception may be reduced when taken with other medicines
| 08 August 2016 |
Women seeking the Norlevo or Levodonna emergency contraceptives should be aware that the efficacy may be reduced when taken with other medicines.
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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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Public funds allocated for research into possible adverse reactions from HPV vaccination
| 08 July 2016 |
Three projects will receive public funds of DKK 7 million, which the Danish Parliament has earmarked for research into possible adverse reactions from HPV vaccination.
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Danish Pharmacovigilance Update, June 2016
| 05 July 2016 |
The June issue of Danish Pharmacovigilance Update.
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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.
