News items 2012

  • Register as a broker of medicinal products or as a manufacturer, distributor or importer of active substances in Denmark

    | 23 January 2013 |

    The new directive on falsified medicinal products was implemented into Danish law on 1 January 2013 after a consultation process. Under the new rules, companies which broker medicinal products and companies which manufacture, import or distribute active substances in Denmark must register their activities with the Danish Health and Medicines Authority.

  • Danish Pharmacovigilance Update, 20 December 2012

    | 17 January 2013 |

    In this issue of Danish Pharmacovigilance Update: The Danish Health and Medicines Authority encourages doctors to be aware of suspected long-term adverse reactions from the use of SSRIs in children and adolescents.

  • Danish Pharmacovigilance Update, 15 November 2012

    | 17 January 2013 |

    In this issue of Danish Pharmacovigilance Update: Chlorhexidine and the risk of anaphylactic reaction.

  • Changes affecting company authorisations and new registrations of companies

    | 21 December 2012 |

    The implementation of directive 2011/62/EU of 8 June 2011 on falsified medicines implies changes to company authorisations. At the same time, the concept of wholesale distribution becomes broader and will in future cover distribution (purchase and sale) of medicinal products whereas before the physical handling of medicinal products was the pivotal element in the granting of wholesale dealer's authorisations (GDP).

  • Time slots for marketing authorisation applications through the decentralised procedure in 2013

    | 20 December 2012 |

    From January 2013 to 31 January 2013 (both days included) companies can request time slots for April, May and June 2013 for submission of applications.

  • New EAN number and CVR number from 1 January 2013

    | 17 December 2012 |

    From 1 January 2013, the Danish Health and Medicines Authority will have a common CVR number and EAN number, which replace the previous numbers of the former National Board of Health and the Danish Medicines Agency.

  • New guideline: renewal of marketing authorisation for nationally authorised medicinal products

    | 10 December 2012 |

    The documentation to be submitted with an application to renew a marketing authorisation for nationally authorised medicinal products now follows the rules which apply to the mutual recognition procedure and the decentralised procedure. Likewise, an application for renewal of a marketing authorisation must be made using the EU form.

  • Annual report on human 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.

  • Companies required to check company authorisation on receipt of medicinal products

    | 27 November 2012 |

    Pursuant to section 20 of the Danish GDP executive order, companies must ensure, as part of their receipt control activities, that they only receive medicinal products from companies which hold a valid company authorisation or from pharmacies.

  • Danish translation of the PhVWP's recommendation for the product information of – donepezil

    | 20 November 2012 |

    The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for donepezil-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.

  • Danish Pharmacovigilance Update, 18 October 2012

    | 15 November 2012 |

    In this issue of Danish Pharmacovigilance Update, read about: Risk of developing hepatotoxicity in patients undergoing treatment with agomelatine (Valdoxan®)

  • Withdrawal of older medicines in Denmark

    | 13 November 2012 |

    A current debate in the Danish media has focused on the withdrawal of a number of older medicines, and we here give a status on the medicines concerned. In 2002, the former Danish Medicines Agency was approached by the Association of Danish Pharmacies concerning 23 named medicines which were all authorised long before the introduction of the first Danish Medicines Act in 1976, mainly in the 1950s.

  • European Medicines Agency has started review of codeine-containing medicines

    | 05 November 2012 |

    On 3 October 2012, the European Medicines Agency (EMA) started a review of codeine-containing medicines. Codeine-containing medicines are used for pain relief in adults and children. Codeine is to a limited degree converted into morphine in the body. It is well-known that some patients convert codeine to morphine at a faster rate than others, resulting in higher than normal levels of morphine in their blood. This may cause side effects such as breathing difficulties.

  • Criticism of CE marking of medical devices in Czech Republic and Slovakia

    | 26 October 2012 |

    The Danish Health and Medicines Authority has asked the European Commission to take action in a case concerning whether two named notified bodies in the Czech Republic and Slovakia comply with EU medical devices law.

  • New, higher-strength insulin on the way

    | 26 October 2012 |

    The European Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended last week that a new analogue insulin can be marketed in the strengths of 100 units/ml and 200 units/ml. The strength of 100 units/ml has for many years been the only strength available for all insulin products. But from the beginning of 2013, it is expected that the new, higher-strength version will be marketed in Europe, and other insulin products of strengths higher than 100 units/ml are expected to be on the way as well.

  • The Danish Health and Medicines Authority maintains influenza vaccine recommendation

    | 19 October 2012 |

    The European Medicines Agency, EMA, has reviewed a hypothesis on Pandemrix® and the development of sleep attacks (narcolepsy). Overall, EMA assesses that there are no grounds for concerns regarding Pandemrix® and other vaccines, including influenza vaccines.

  • Benefits of NSAIDs still outweigh risks - but diclofenac may be associated with a small increased risk of side effects

    | 19 October 2012 |

    In October 2011, the Committee for Medicinal Products for Human Use (CHMP) decided to review the newest data on cardiovascular side effects from analgesics (painkillers) of the NSAID type. The conclusions are now available, and they confirm the previous conclusions from 2005 and 2006 that the benefits of NSAIDs still outweigh the risks.

  • Danish Pharmacovigilance Update, 20 September 2012

    | 17 October 2012 |

    Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.

  • European Commission proposes two new regulations on medical devices and in vitro diagnostic devices

    | 16 October 2012 |

    The European Commission has proposed two new regulations on medical devices and in vitro diagnostic devices. This launches the European Union's (EU) legislative decision-making process

  • The Danish Health and Medicines Authority still recommends influenza vaccine

    | 15 October 2012 |

    The Danish Health and Medicines Authority still recommends using the Fluarix® seasonal flu vaccine for people who are in a risk group.