Human and veterinary medicinal products

  • Review and submission of marketing authorisation applications to the Norwegian Medicines Agency (NoMA)
  • Translation (primarily from English) and submission of Norwegian product information (Summary of Product Characteristics/Labelling/Package leaflet/Annexes)
  • Review/approval of packaging materials for submission and printing
  • Maintenance of marketing authorisations (applications for variations, renewals etc.)
  • Carry out readability tests (user tests) of Norwegian package leaflets
  • Preparation and submission of Norwegian additional risk minimisation measures materials (educational materials/RMP materials)
  • Preparation¬†and¬†updating texts for the Norwegian Pharmaceutical Compendium (Felleskatalogen)