Publications 2015

  • Market surveillance project 2014 - Inspection of dental laboratories and analyses of fixed dental prosthetics

    | 24 July 2015 |

    The Danish Health Authority carried out 16 inspections of dental laboratories in 2014 and presents the results of the project in this market surveillance report. The purpose of the project was to ex

  • 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

  • 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 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.

  • Adverse drug reaction reports (ADRs) from consumers may improve patient safety

    | 20 March 2013 |

    In a report, the DHMA has reviewed the ADR reports received during the years 2003–2011 to clarify how consumer reports differ from reports from healthcare professionals.

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