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Approval of medicines
Approval and follow-up of marketing authorisation (MA)
Other information regarding MA

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Approval and follow-up of marketing authorisation (MA)

Application for marketing authorisation
Renewal of MA
Variations regarding marketing authorisation
- Transfer of MA/change in name and address of the MAH
- Supplementary information regarding variation applications in NP
  - Batch-specific variation applications
Medicinal products to be distributed without medical prescription
Parallel import: Application for MA and post-marketing obligations
- Application for MA for parallel importet medicinal products
- Post-marketing obligations for parallel imported medicinal product
Product information - templates and guidance
Notification of shortages or withdrawal of medicinal product in Norway
Other information regarding MA
Product information - recommended updates
- Recommendations after referral adopted by the European Commission

Other information regarding MA

Published: 10/10/2023

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