1 - 20 of 298 news items
  • Executive order on euphoriant substances – nine new substances

    | 31 August 2015 |

    On 25 August 2015, new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.

  • New organisation structure of DHMA

    | 11 August 2015 |

    The Danish Medicines Agency to be re-established as an independent agency.

  • Asthma inhaler recalled

    | 05 August 2015 |

    Pharmaceutical company AstraZeneca recalls a batch of Bricanyl Turbuhaler. One inhaler of this batch is empty and contains no medicine.

  • Increase in clinical trial applications

    | 03 August 2015 |

    An increasing number of clinical trial applications, improved production and assessment performance, but also longer assessment times.

  • Danish Pharmacovigilance Update, June 2015

    | 14 July 2015 |

    The June issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.

  • New format requirements for applications for authorisation of medicinal products

    | 13 July 2015 |

    On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency (EMA).

  • Clinical trial authorisation applications

    | 06 July 2015 |

    In 2014, the Danish Health and Medicines Authority received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% compared to 2013. Commercial sponsors applied for 162 trials and researchers for 122.

  • Guide to individual case safety reporting

    | 26 June 2015 |

    We have prepared a guide to companies on the electronic reporting of adverse drug reactions (ADR) to the Danish Health and Medicines Authority.

  • Global operation against illicit medicines completed

    | 19 June 2015 |

    A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

  • CUG certificates for login to DKMAnet must be replaced

    | 12 June 2015 |

    The Danish Health and Medicines Authority has to replace the system used to issue Closed User Group (CUG) certificates to users of DKMAnet who cannot obtain a NemID employee certificate, i.e. primarily users employed in companies without a Danish CVR registration number. If you are currently using a CUG certificate of the old type to log in to DKMAnet, you must obtain a new certificate before 1 September 2015.

  • Danish Pharmacovigilance Update, May 2015

    | 09 June 2015 |

    The May issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.

  • Many addictive drugs lacked statutory packaging seal

    | 08 June 2015 |

    The Danish Health and Medicines Authority’s laboratory has made a thorough investigation and found that 70 of 229 addictive drugs in the Danish market lacked the statutory packaging seal on the outer packaging. The seal makes it easy to determine whether the package has been broken before it reaches the end user. The aim is to prevent abuse.

  • National Clinical Guideline: prevention and treatment of dystocia

    | 02 June 2015 |

    An English version of our national clinical guideline concerning primiparous women with dystocia is now available on our website.

  • Danish Pharmacovigilance Update, April 2015

    | 08 May 2015 |

    The April issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:

  • Annual Pharmacovigilance Report 2014

    | 08 May 2015 |

    In our annual pharmacovigilance report 2014, you can read about the development in the number of ADR reports, learn about various focus areas and the European collaboration in the pharmacovigilance area as well as see a selection of the ADR signals we processed in 2014, and much more.

  • EMA's new assessment of the HPV vaccine: The benefits outweigh the risks

    | 17 April 2015 |

    A causal relationship between the dizziness and fatigue syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Gardasil can neither be confirmed nor denied. The EU's group of pharmacovigilance experts have made a new assessment of the vaccine and still consider it to be safe.

  • Danish Pharmacovigilance Update, March 2015

    | 10 April 2015 |

    The March issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.

  • New guidelines on good distribution practice for APIs

    | 31 March 2015 |

    The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.

  • New advice on infant food

    | 17 March 2015 |

    Infants should not be given cow's milk, but breast milk or infant formula throughout the first year of life. This is one of our new recommendations for infant food and nutrition for young children.

  • New management at the DHMA

    | 16 March 2015 |

    As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Anne-Marie Vangsted will continue as Director with special responsibility for the DHMA's supervision.