Publications
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Product defects and withdrawal of medicines 2011
| 26 November 2012 |
In 2011, 356 reports of medicinal product defects were registered, which is the highest number ever. The majority of the reports came from companies and other authorities and predominantly concerned defects on the package and packaging material and deviations from specifications.
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Annual report human on tissues and cells 2011
| 07 December 2012 |
The annual report for human tissues and cells for 2011 has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by tissue establishments and gynaecology clinics in Denmark in the period January to December 2011.
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Danish Medicines Agency's annual pharmacovigilance report 2011
| 01 August 2012 |
The annual pharmacovigilance report offers an insight into some of the pharmacovigilance work performed by the Danish Medicines Agency in 2011.
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Annual report on clinical trials of medicines in humans 2011
| 07 June 2012 |
The Danish Health Authority has published its annual report 2011 on applications for clinical trials of medicines in humans.
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Number of applications for individual reimbursement of medicines in 2011
| 02 March 2012 |
In 2011, the Danish Medicines Agency (now the Danish National Board of Health) reviewed approx. 103,000 applications for single reimbursement (about 7 % more than in 2010), approx. 26,000 applications for reimbursement for the chronically ill (about 30 % less than in 2010), approx. 12,000 applications for reimbursement for the terminally ill (about 3 % more than in 2010) and approx. 2,500 applications for increased reimbursement (about 12 % less than in 2010), cf. table 1.
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Report on compliance with rules on good manufacturing practice by manufacturers of active pharmaceutical ingredients
| 20 May 2010 |
Since December 2005, it has been a requirement that any active pharmaceutical ingredients (API) used in medicines with a marketing authorisation in Denmark must be manufactured in compliance with the
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Product defects and withdrawal of medicinal products in 2009
| 15 June 2010 |
In 2009, 186 reports of medicinal product defects were registered, which is slightly more than in 2008. Compared to 2008, the reporting sources and types of defects have shifted, and reports from the Danish Medicines Agency's own control system accounted for a larger share in 2009 compared to 2008.
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Report on the blood product area in 2009
| 17 August 2010 |
In 2009, 358.000 blood collections were made in Denmark. This is approximately 4.000 collections more than the previous year. Moreover, approximately 332.000 units of red blood cells (erythrocytes) were used in connection with blood transfusions in 2009.
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Assessment of safety of methylphenidate in ADHD treatment
| 29 October 2010 |
The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.
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Number of applications for individual reimbursement of medicinal products in 2009
| 31 March 2010 |
Reimbursement for the chronically ill Increased reimbursement Single reimbursement Medicinal product groups generating the highest number of single reimbursement applications Electronic ap
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Annual report 2009 of the Danish Medicines Agency's laboratory control activities
| 14 June 2010 |
The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2009 that d
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Annual report on human tissues and cells 2009
| 01 November 2010 |
The Danish Medicines Agency's annual report on human tissues and cells has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by the tissue establishments and gynaecology clinics in Denmark in the period January to December 2009.
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Annual report on human tissues and cells 2008
| 05 March 2010 |
The Danish Medicines Agency's annual report on human tissues and cells has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by the tissue establisments and gynaecology clinics in Denmark in the period January to December 2008
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Annual report of the Reimbursement Committee 2009
| 23 April 2010 |
Members appointed by the Danish Minister for the Interior and Health 17 meetings in 2009 21 applications for general reimbursement Grounds 1632 applications for individual reimbursement Annual
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Danish Medicines Agency’s annual pharmacovigilance report 2009
| 29 March 2010 |
The annual report offers an insight into the pharmacovigilance work performed by the Danish Medicines Agency in 2009.
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Report on the blood product area in 2007
| 13 October 2008 |
The blood product report is published every year based on figures from the Danish blood centres and the Blood-donors in Denmark.
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Product defects and withdrawal of medicinal products in 2007
| 19 May 2008 |
In 2007, 202 reports about medicinal product defects were registered, which is basically on level with 2006. 28 % of these reports resulted in a withdrawal from the Danish market, which is exactly the same proportion as the year before.
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Survey of pharmaceutical companies' satisfaction with the Danish Medicines Agency
| 19 September 2008 |
The research company Capacent Epinion has asked pharmaceutical companies to indicate their level of satisfaction with the Danish Medicines Agency. A total of 40 companies participated in the survey, which was carried out in May to June 2008.
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Danish Medicines Agency annual accounts 2007
| 22 April 2008 |
In 2007, the Danish Medicines Agency achieved a target performance of 93.9 per cent in respect of the targets set out in the performance contract with the Danish Ministry of Health and Prevention, corresponding to a fulfillment of three in every four sub-requirements. Overall, we assess that we delivered good technical results in 2007, among other things, based on the fact that the most strategically important performance requirements were fulfilled.