News items 2015
New chair of PhVWP-V
| 20 December 2016 |
Lisbet Vesterager Borge, veterinarian, has been elected chair of the European Pharmacovigilance Working Party Veterinary (PhVWP-V).
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Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.
The Danish Medicines Agency launches new strategy
| 15 December 2016 |
The Danish Medicines Agency: Among Europe's best in class! This is our vision and we are now launching a strategy for how we are going to achieve the vision.
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.
Danish Pharmacovigilance Update, November 2016
| 09 December 2016 |
The November issue of Danish Pharmacovigilance Update.
Interactive Adverse Drug Reaction overviews
| 08 December 2016 |
The Danish Medicines Agency has launched a new web-based database that researchers and other interested parties can use to search for reported suspected adverse reactions.
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.
How the HPV vaccine works
| 30 November 2016 |
The Danish Medicines Agency has made a short video graphic about the efficacy of the HPV vaccine.
Nikolai Brun appointed new Director of Division
| 24 November 2016 |
The Danish Medicines Agency strengthens its leadership team and appoints Nikolai Brun, MD and PhD, as Director of Division of the new Medical Evaluation & Biostatistics division.
Danish Pharmacovigilance Update, October 2016
| 15 November 2016 |
The October issue of Danish Pharmacovigilance Update.
Danish Pharmacovigilance Update, September 2016
| 03 November 2016 |
The September issue of Danish Pharmacovigilance Update.
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.
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.
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.
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.
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.
Danish Pharmacovigilance Update, August 2016
| 13 September 2016 |
The August issue of Danish Pharmacovigilance Update.
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.
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.
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.