Meny

• About Norwegian Medicines Agency
• Clinical trials
• Compassionate use
• Contact information
• Electronic transmission of Adverse Drug Reactions (ADR)
• Fees
• National implementation of Commission Decision after a Community referral to arbitration
• News
• Price and reimbursement
• Regulatory affairs
  • Electronic submission of SPC/PIL – national procedure
  • Electronic submissions
  • Formatting electronic versions of Summary of Product Characteristics (SPC) and Package Information Leaflet (PIL)
  • Introduction of additional fee for variation applications
  • Notification of marketing interruption of a medicinal product in Norway, including withdrawal
  • The new variation regulation – Implementation in Norway
  • Transfer of the Marketing Authorisation/Change in name and address of MA Holder
• Short survey of Norwegian legislation concerning import, wholesaling and retailing of pharmaceuticals.
• SPC