National requirements for application for marketing authorization in the Nordic countries

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Scope: This document should be read as an overview of the number of dossier copies for different approaches for submission. Please note that there are further national requirements for additional documents in the different countries.

Sweden

Paper submission:

  • 1 paper copy of the full dossier
  • 1 electronic copy of the dossier on CD or DVD is strongly recommended
  • 1 electronic copy of the product information texts

Electronic submission:

  • 1 electronic copy of the dossier on CD or DVD in NeeS or eCTD format
  • Cover letter in paper

Norway

Paper submission:

  • 1 paper copy of the full dossier
  • 1 electronic copy of the dossier on CD or DVD is strongly recommended
  • 1 electronic copy of the product information texts

Electronic submission:

  • 1 electronic copy of the dossier on CD or DVD in NeeS or eCTD format (3 copies if Norway is reference member state)
  • Cover letter in paper with original signature (application form in paper with original signature is not required if the same person signs both cover letter and application form)

Denmark

Paper submission:

  • 1 paper copy of the full dossier (if an electronic copy of the dossier is also submitted) alternatively 1 paper copy of the full dossier + 1 extra paper copy of module 1 and 2 (if an electronic copy of the dossier is not submitted)
  • 1 electronic copy of the product information texts

Electronic submission:

  • 1 electronic copy of the dossier on CD or DVD in NeeS or eCTD format
  • Cover letter in paper with original signature
  • A paper copy of the application form is strongly recommended but not required

Finland

Paper submission:

  • Paper submission is only accepted in exceptional cases. Instructions on how to make submissions following this exceptional procedure are published on www.fimea.fi

Electronic submission:

  • 2 electronic copies of the dossier on CD or DVD in NeeS or eCTD format
  • Cover letter in paper with original signature
  • Application form in paper

Iceland

Paper submission:

  • 1 paper copy of the full dossier
  • 1 electronic copy of the product information texts

Electronic submission:

  • 1 electronic copy of the dossier on CD or DVD in NeeS or eCTD format
  • Cover letter in paper with original signature
  • Application form in paper with original signature

This information was last updated 2011-04-01

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