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    • Relationships
    • Financial support
    • Medicinal Products Committee
    • Publications
  • Side effects and product information
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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
    • Legislation and guidance
    • Publications
  • Special product areas
    • Veterinary medicines
    • Natural medicinal products and vitamin and mineral products
    • Euphoriant substances
    • Medical gases
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    • Regulation of innovative medicinal products including ATMP
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  • 2022 deadline for submitting applications concerning marketing authorisations and clinical trials

    | 19 October 2022 |

    The deadline for submitting applications concerning marketing authorisations and clinical trials is 20 December 2022. The Danish Medicines Agency is closed for the Holiday Season, from 24 December, 2022, until 1 January, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before 20 December, 2022. We will consider applications submitted after 20 December, 2022, as if they have been received 2 January 2023.

  • Current Danish QRD template to be used in connection with the granting of marketing authorisations

    | 11 October 2022 |

    Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as w

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