• Overview of changes requiring an inspection in the GMP area

    | 23 January 2018 |

    Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

  • Updating of summaries of product characteristics due to changed ATC codes for 2018

    | 18 January 2018 |

    Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2018.

  • DKMA Update December 2017

    | 09 January 2018 |

    In this issue of DKMA Update, you can read about the new medicinal cannabis pilot programme, about how to read the summary of product characteristics, and about two new studies on the use of contraceptive pills and adverse reactions.

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