Side effects and product information
Pharmacies and sale of medicines
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.
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.
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.
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.
From old industrial plant to open workspace
| 21 November 2011 |
The Danish Medicines Agency's introductory leaflet about the transformation from old soya bean cake factory into a streamlined modern workplace. From old industrial plant to open workspace.
Annual report on human tissues and cells 2010
| 28 October 2011 |
The annual report for human tissues and cells for 2010 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 2010.
Publication on medicines most frequently involved in serious adverse drug events
| 12 October 2011 |
A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.
Danish report on treatment with SSRI antidepressants
| 27 September 2011 |
Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.
Product defects and withdrawal of medicines 2010
| 12 September 2011 |
In 2010, the Danish Medicines Agency received a total of 262 reports on product defects involving medicines. This is the highest number of reports received within the past five years.
Annual report on the inspection of retail sale of OTC medicines 2009-2010
| 24 August 2011 |
In our report for 2008-2009, we made a number of critical remarks about the pharmacies' OTC outlets where we found too many deficiencies: expired medicines, possibility of self-service, medicines mixed with other goods, staff which did not know the rules, etc.
Report on the blood product area in 2010
| 12 August 2011 |
In 2010, 337.000 blood collections were made in Denmark. This is approximately 21.000 collections less than the previous year. Moreover, approximately 317.000 units of red blood cells (erythrocytes) were used in connection with blood transfusions in 2010.
Annual report 2010 of the Danish Medicines Agency's laboratory control activities
| 22 July 2011 |
he drug regulatory authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2010 that describes the activities of the Agency to the OMCL network.
Danish Medicines Agency’s annual pharmacovigilance report 2010
| 20 June 2011 |
In 2010, primarily the Danish Minister for the Interior and Health’s action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.
Number of applications for individual reimbursement of medicines in 2010
| 14 June 2011 |
In 2010, we reached decisions in a total of 144,324 individual reimbursement applications against 138,714 in 2009, corresponding to an increase of 4 %. The figure breaks down to approx. 96,000 applications for single reimbursement (about 3 % fewer than in 2009), approx. 34,000 applications for reimbursement for the chronically ill (about 30 % more than in 2009), approx. 12,000 applications for reimbursement for the terminally ill (about 7 % more than in 2009) and approx. 2,800 applications for increased reimbursement (about 14 % more than in 2009).
Danish Medicines Agency annual accounts 2010
| 27 April 2011 |
The full report, which is in Danish only, is available via the box.
Performance contract 2010/2011
| 30 March 2011 |
The Danish Medicines Agency and the Ministry of Interior and Health have signed a performance contract.
Annual report of the Reimbursement Committee 2010
| 23 March 2011 |
In 2010, the Reimbursement Committee reviewed 20 applications for general reimbursement and 1719 applications for individual reimbursement.
Perspectives and challenges of the Danish Medicines Agency
| 03 March 2011 |
Over the past few years, we have developed a strategy to address the challenges of the Danish Medicines Agency and to prioritise accordingly. Our strategy has fostered a number of action plans, which describe the areas that we want to focus on in particular.
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.
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.