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    • Evaluation of reviews
    • Report suspected illegal activities
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    • Relationships
    • Financial support
    • Medicinal Products Committee
    • Publications
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    • Biological and biosimilar medicinal products
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    • 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
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    • Natural medicinal products and vitamin and mineral products
    • Euphoriant substances
    • Medical gases
    • Radiopharmaceuticals
    • Medicines affecting the ability to drive
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    • Regulation of innovative medicinal products including ATMP
2016
News / 2016
News

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  • New comprehensive list of euphoriant substances regulated in Denmark

    | 26 February 2016 |

    You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.

  • Form for notification of invoice details concerning clinical trials discontinued

    | 23 February 2016 |

    The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.

  • Twelve new substances on the list of euphoriant substances

    | 17 February 2016 |

    As of 18 February 2016, 12 new substances are included in the Danish executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.

  • Danish Pharmacovigilance Update, January 2016

    | 10 February 2016 |

    The January issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

  • EMA: No changes to the safety profile of Gardasil

    | 09 February 2016 |

    The European Medicines Agency (EMA) has recently completed its annual routine safety assessment of the HPV vaccine Gardasil®. The conclusion is that there are no changes to the safety profile.

  • Updated list of biological medicinal products

    | 04 February 2016 |

    The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.

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