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)
