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    • Evaluation of reviews
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    • Relationships
    • Financial support
    • Medicinal Products Committee
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    • News on pharmacovigilance
    • Biological and biosimilar medicinal products
    • Safety updates
    • Post Authorisation Safety Study
    • Direct Healthcare Professional Communication
    • Adverse events
    • Drug interaction
    • Pharmacovigilance Council
    • Find medicines
    • Publications
  • Reimbursement and prices
    • General reimbursement
    • Individual reimbursement
    • Reimbursement thresholds
    • Medicines bought in another EU/EEA country
    • Reimbursement Committee
    • The EU HTA regulation
    • Prices of medicines
    • Product numbers
    • Central Reimbursement Register
    • Reimbursable nutritional products
    • Publications
  • Pharmacies and sale of medicines
    • Pharmacies
    • Sale outside pharmacies
    • Over-the-counter medicines
    • Substitution
    • Medicines imported from abroad
    • Buying and selling medicines online
    • Sale of medicines or food supplements online
    • Doctors buying medicines for use in their own practices
    • Report suspected illegal sale of medicines
    • Prescriptions from another country
    • Publications
  • Medical devices
    • Incident reporting
    • New regulations
    • COVID-19 antigen test for self-test
    • Advice to consumers on buying face masks
    • New Tech – new technological possibilities and medical devices
    • Interruption or discontinuation of the supply of medical devices
    • Patient safety and safe medical devices
    • Development of medical devices
    • Regulatory advice for medical device companies
    • CE marking
    • Notified bodies
    • Registration and marketing
    • Clinical investigations
    • Performance studies of in vitro diagnostic medical devices (IVDs)
    • Certificates of Free Sale
    • Legislation and guidance
    • Publications
  • Special product areas
    • Veterinary medicines
    • Natural medicinal products and vitamin and mineral products
    • Euphoriant substances
    • Medical gases
    • Radiopharmaceuticals
    • Medicines affecting the ability to drive
    • Medicinal cannabis
    • Regulation of innovative medicinal products including ATMP
2016
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  • 13 December 2023 is the deadline for our review of export certificates for medicinal products before Christmas

    | 28 November 2023 |

    Applications for export certificates for medicinal products must reach us by 13 December 2023 to be reviewed and issued before Christmas.  Any applications submitted after 21 December will be consid

  • Notification of changes in medicine prices and product ranges between Christmas and New Year 2023

    | 28 November 2023 |

    The Danish Medicines Agency is closed over Christmas and New Year. We will therefore not be offering support in relation to the notification of medicine prices and product ranges from Monday 25 Dece

  • Deadline for receipt of applications for company authorisations is 15 December in 2023

    | 28 November 2023 |

    Your application for a company authorisation must reach us by 15 December 2023 for the review to start before Christmas. Any application received after that will be considered received on 2 January

  • Last day for submission of applications for certificates of free sale to export medical devices is 13 December 2023

    | 28 November 2023 |

    The last day for submitting an application for a certificate of free sale to export a medical device  will be Wednesday 13 December 2023. Any application received after that will be considered re

  • Deadlines to apply for the issuance of import/export certificates for euphoriant substances before Christmas

    | 28 November 2023 |

    Applications for import/export certificates received via NDS Web must reach us by 15 December 2023 to be reviewed before Christmas. Applications submitted in any other way must reach us by 8 Decembe

  • Danish Medicines Agency closed over Christmas and New Year

    | 28 November 2023 |

    The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023.

  • Applications for compassionate use permits on weekdays between Christmas and New Year

    | 28 November 2023 |

    The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2024. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).

  • 2023 deadline for submitting applications concerning marketing authorisations and clinical trials

    | 13 November 2023 |

    The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2023. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2023, until January 1, 2024, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2023. We will consider applications submitted after December 20, 2023, as they have been received January 2, 2024.

  • First electronic product information published for medicines

    | 09 November 2023 |

    Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU.

  • More reports at the beginning of the vaccination programme, but no suspicion of safety differences between COVID-19 vaccine batches

    | 01 November 2023 |

    A new analysis from the Danish Medicines Agency shows that the number of reports of suspected side effects after vaccination with COVID-19 vaccines is highly related to the time the individual vaccine batches were used.

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