Product introduction to the Nordic market

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Wholesale dealer licence for medicinal products, either in the local country or within the European Union, is required. Please contact Sofus for specific questions regarding the respective Nordic countries or if you are in need of a local representative.

Sweden

  • Contract distributor
  • Set a price and (if applicable) apply for reimbursement
  • Apply for Nordic Article Number (Vnr)
  • Arrange an EAN code
  • Update NPL (Nationellt Produktregister för Läkemedel); a national repository for medicinal products available on the Swedish market
  • Introduce the company and product to fass.se (recommended)
  • Inform the Medical Products Agency before the product is placed on the market

Norway

  • Contract distributor
  • Apply for a maximum price and (if applicable) apply for reimbursement
  • Apply for Nordic Article Number (Vnr)
  • Arrange an EAN code
  • Update the Article Number Register (Vareregistret, operated by Farmalogg AS)
  • Introduce the company and product to Felleskatalogen (recommended)

Denmark

  • Contract distributor
  • Set a price and (if applicable) apply for reimbursement
  • For OTC products, agreement with DAF (Danmarks Apotekerforening) for product distribution
  • Apply for Nordic Article Number (Vnr)
  • Arrange an EAN code
  • Submit product information to DLI (Dansk Lægemiddel Information)
  • Inform the Danish authority about marketing start date and price, and upload package leaflet (via DKMAnet)

Finland

  • Contract distributor
  • Set a price and (if applicable) apply for reimbursement
  • Apply for Nordic Article Number (Vnr)
  • Arrange an EAN code
  • Introduce the company and product to Pharmaca Fennica (recommended)
  • Inform FIMEA about persons responsible for Regulatory Affairs and Pharmacovigilance
  • Inform FIMEA about the marketing start date

Iceland

  • Contract distributor
  • Apply for price to the Medicinal Products Pricing Committee
  • Apply for approved price to be published in The Icelandic Pharmaceutical Price list
  • Apply for Nordic Article Number (Vnr)
  • Arrange an EAN code
  • Submit artwork samples to the IMA after approval

This information was last updated 2011-03-01

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