News about Licensing and supervision

  • Danish Medicines Agency increases communication on medicine supply

    | 24 June 2020 |

    The Danish Medicines Agency reinforces the communication about the supply of medicines in Denmark through announcements that will be sent out when supply problems are expected to have therapeutic consequences for the patients.

  • COVID-19: Regulatory guidance in connection with COVID-19 and possible impact on assessment times

    | 04 June 2020 |

    The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA – have prepared common regulatory guidance for marketing authorisation holders. The guidance can be used during the COVID-19 pandemic and describes situations in which the authorities will apply flexibilities during the pandemic. (updated)