Regulatory affairs

MARKETING AUTHORISATION APPLICATIONS
Important information regarding marketing authorisations in Mutual Recognition (MRP) and Decentralized Procedure (DCP) where Norway is concerned member state (CMS).

From December 2010 The Norwegian Medicines Agency (NoMA) will comply with the deadlines of processing marketing authorisation applications in MRP and DCP. There are exceptions where NoMA is in correspondence with the applicant or where sufficient product information is missing.
The NoMA kindly asks you to submit the final Norwegian product information within five working days after end of procedure.

Please submit the following documents:
- Summary of product characteristics (SmPC)
- Package leaflet
- Mock-ups

In case the product will not be marketed in Norway:
Please send a confirmation within two weeks to pi@noma.no. If the NoMA does not receive the final Norwegian product information or a confirmation within the deadline, the marketing authorisation will be granted without the Norwegian product information.

New! MA-number - Centralized procedure

• MA-number - Centralized procedure (05.05.2011)
• Handling of changes to DDPS (07.02.2011)
• Centralised procedure variations (21.10.2010)
• Introduction of additional fee for variation applications (02.09.2010)
• Notification of marketing interruption of a medicinal product in Norway, including withdrawal (16.08.2010)
• EU regulation implemented in Norwegian legislation (11.02.2010)
• The new variation regulation – Implementation in Norway (17.12.2009)
• Electronic submissions (21.10.2009)
• Electronic submission of SPC/PIL – national procedure (31.03.2008)
• Formatting electronic versions of Summary of Product Characteristics (SPC) and Package Information Leaflet (PIL) (31.03.2008)
• Request for Norway as RMS in decentralised procedure (14.02.2008)
• WHO-certificates (10.08.2007)
• Transfer of the Marketing Authorisation/Change in name and address of MA Holder (20.09.2006)
• Updating of marketing authorisations (MA) for medicinal products not marketed in Norway (28.03.2006)
• Summary of Product Characteristics (SPC) on the web of the Norwegian Medicines Agency (NoMA) (28.03.2006)
• “Blue Box” for Norway in package leaflet and label (28.03.2006)
• Number of copies to be submitted in MRP/DCP (03.01.2006)
• Delayed implementation of EU's new pharmaceutical legislation in the EEA EFTA states (27.09.2005)
• ”Excipients guideline” with Norwegian translation (04.05.2004)
• Circular 11/2003 (31.10.2003)
• Applications for Marketing Authorisation