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  • Danish Medicines Agency annual report 2006

    | 12 September 2007 |

    In the report for 2006, we have chosen to bring you samples of how we put our values into practice in our daily activities. Read more about how we have been competent, trustworthy, attentive, receptive and European from the fact box to the right.

  • Performance contract 2009

    | 03 July 2009 |

    The Danish Medicines Agency and the Ministry of Health and Prevention have agreed upon a performance contract, which is valid for 2009. The contract, which is in Danish only, focuses on external targets that cover the Danish Medicines Agency's tasks to the greatest extent possible.

  • Product defects and withdrawal of medicinal products in 2008

    | 16 April 2009 |

    In 2008, 177 reports of medicinal product defects were registered, which is less than in 2007. 23 % of these reports led to products being withdrawn from the market, which is also less than in the preceding years. Most of the withdrawals effected in 2008 were occasioned by reports made by the companies.

  • Danish Medicines Agency annual accounts 2008

    | 17 April 2009 |

    In 2008, the Danish Medicines Agency achieved a target performance of 91.9 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 four in every five sub-requirements. Overall, we find that we delivered good technical results in 2008.

  • Annual report on the inspection of retail sale of OTC medicines 2008-2009

    | 23 July 2009 |

    In 2008, the Danish Medicines Agency intensified its efforts on removing expired over-the-counter medicine from retail distribution.

  • Number of applications for individual reimbursement of medicinal products in 2008

    | 28 April 2009 |

    Reimbursement for the chronically ill Increased reimbursement Single reimbursement Medicinal product groups subject to the most single reimbursement applications In

  • Product defects and withdrawal of medicinal products in 2005

    | 15 November 2006 |

    In 2005, there was almost the same number of reports on product defects as in 2004. The reports comprised both marketed and non-marketed medicinal products, including magistral medicinal products, which are manufactured according to a doctor's prescription.

  • Danish Medicines Agency annual report 2005

    | 29 August 2006 |

    The effort on ensuring consumer safety became very visible in the spring of 2005 when we decided to set up an individual division under this heading. Enhancing the safety of medicine users will also be the result of the new Medicines Act which entered into force in December.

  • Examination of single reimbursement for medicinal products

    | 31 July 2006 |

    On behalf of Merck Sharp & Dohme (MSD), Tranberg Marketing Rekommandation has examined general practitioners' knowledge, experience and attitude to single reimbursement for medicine ("Praktiserende lægers kendskab, erfaring og holdning til enkelttilskud til medicin"). The examination is based on telephone interviews with 282 general practitioners.

  • Clinical trials of medicines - Annual report 2016

    | 13 June 2017 |

    Last year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.

  • Annual report on clinical trials of medicines in 2017

    | 12 June 2018 |

    The number of applications for clinical trials of medicines increased in 2017 compared to 2016, so shows the recently published annual report on clinical trials in Denmark in 2017. In 2017, the Danish Medicines Agency received 324 applications for clinical trials of medicines in humans, which is an impressive 13% increase compared to 2016. Denmark’s share of the total number of clinical trial applications in the EU has also increased steadily – from 9% in 2015 and 10% in 2016 to 12% in 2017, even though the period recorded a fall in the total number of trials in the EU.

  • Annual pharmacovigilance report 2015

    | 25 April 2016 |

    Openness and dialogue are keywords in the Danish Medicines Agency's work with adverse reactions. In 2015, this was to become particularly important. Since 2009, almost 2,000 girls and young women had reported suspected adverse reactions to the Gardasil® HPV vaccine, and patient organisations and the media wanted us to join the debate.

  • Annual pharmacovigilance report 2013

    | 30 June 2014 |

    In 2013, the Danish Health Authority, DHMA, received the highest number of adverse reactions ever. A total of 6681 adverse reactions were reported to us, which is 35% more than the year before. The boost in reports is attributable to several aspects. A number of targeted campaigns have put increased focus on the area, but also the development and implementation of better IT services have made it easier to report adverse drug reactions (ADRs). Especially the HPV vaccine against cervical cancer got a lot of attention in 2013 and accounted for a large proportion of the ADR reports.

  • Annual report 2014 - Clinical trials of medicines

    | 06 July 2015 |

    In 2014, DHMA received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% on 2013. Commercial sponsors applied for 162 trials and researchers (non-c

  • Annual Pharmacovigilance Report 2014

    | 08 May 2015 |

    In 2014, the number of adverse drug reaction (ADR) reports in the Danish adverse reaction database came close to 100,000. The ADR reports go as far back as the late 1960s when the first national system for registration of adverse reactions was established.

  • Guide to individual case safety reporting

    | 26 June 2015 |

    We have prepared a guide to pharmaceutical companies about the exchange of individual case safety reports to and from the Danish Health Authority. The guide is in English and includes recommendation

  • Annual Report 2012 on laboratory control activities

    | 05 August 2013 |

    The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Health Authority has published an annual report for 2012 that describes our activities to the OMCL network.

  • Annual pharmacovigilance report 2012

    | 07 August 2013 |

    In the Danish Health Authority's (DHMA's) annual pharmacovigilance report, you can read about some of the pharmacovigilance work performed by the DHMA in 2012.

  • Annual report on clinical trials of medicines in humans 2012

    | 25 October 2013 |

    The Danish Health Authority has published its annual report 2012 on applications for clinical trials of medicines in humans.

  • 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.

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