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Service: Marketing authorisation maintenance (human medicines)

  • Maintaining a marketing authorisation in the EU: MAH responsibilities after approval

    11.03.2026

    regulatory lifecycle activities
  • The new EC variation guideline applies 15 January 2026

    14.01.2026

    CMC
  • Pharma marketing compliance in the Nordics: key rules and differences

    23.09.2025

  • Promotional material compliance in the Baltics: Key requirements for medicines, medical devices, food supplements and cosmetics

    06.06.2025

    Promotional material compliance in the Baltics
  • Medfiles and LINK Medical: partners in regulatory and pharmacovigilance services in Northern Europe

    28.05.2025

  • Ensuring quality in medicinal product distribution: Medfiles as LEO Pharma’s responsible pharmacist in Finland

    30.01.2025

  • How to avoid medicinal product shortages: key considerations for MAHs 

    30.12.2024

    medicinal product shortages
  • Changes to EU variations coming in 2025

    26.06.2024

    EU variations
  • Global pharma company & Medfiles: cooperation in obtaining and maintaining marketing authorisations in the EU

    08.03.2024

    obtaining and maintaining marketing authorisations in the EU
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