Procedural guidance is available on the HMA website for MR/DC procedures and on the EMA website for the centralised procedure.

NB! An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance.

Important information regarding marketing authorisations in Mutual Recognition (MR) and Decentralised (DC) procedures

Please submit the Product Information within 7 days (human medicines) or 5 days (veterinary medicines) after the End of Procedure. 

The NoMA has introduced the possibility of granting an MA without the Norwegian product information. This “conditional” MA can be obtained in case the MAH has no intention of marketing the product in Norway. Please note that this option does not apply to line extension applications where the prior approved MAs are MAs with approved Norwegian Product Information.

In case the product will not be marketed in Norway:
Please send a confirmation within two weeks of End of Procedure 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.

Change in marketing plans:
If it is decided at a later stage that the product should be placed on the Norwegian market, the following must be assessed and approved by the NoMA:

• SmPC
• PL
• Mock-ups

Note that the NoMA require submission of mock-ups, and the approval will not be granted before the Norwegian product information with mock-ups is submitted. The Norwegian product information should be submitted two months prior to the planned marketing date.

Changes in the product information caused by variation procedures approved after the MA-procedure must be implemented in the Norwegian texts (marked with the track changes function). Please list the variation procedure numbers and approval dates in the submission.​