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    • Medicinal Products Committee
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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
    • Calculate reimbursement
    • 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
    • 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
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    • Veterinary medicines
    • Natural medicinal products and vitamin and mineral products
    • Euphoriant substances
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    • Medicinal cannabis
    • Regulation of innovative medicinal products including ATMP
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  • New CMDv Guidance on the Submission of G.I.18 Variations

    | 12 June 2024 |

    CMDv has published guidance on the submission of G.I.18 variations requiring assessment. The Danish Medicines Agency requests that all Marketing Authorisation Holders (MAHs) carefully review the principles in this document to ensure the process of submitting and obtaining approval of a G.I.18 variation is as efficient and smooth as possible.

  • Tidsfrister & CTIS: Tidsfrister for kliniske forsøg skal overvåges i CTIS og forordningsforsøg skal overføres til CTIS

    | 10 June 2024 |

    Læs mere om CTIS timetable med tidsfrister for kliniske forsøg samt tidsfrister for overførsel til CTIS af forsøg der er opstartet under forordningen. Alle kliniske forsøg der skal fortsætte efter 30 januar 2025 skal overføres til CTIS.

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