​The application forms to be used are the same, regardless of the procedure chosen, and can be downloaded from the Eudralex website. For medicinal products for veterinary use, please see EudraLex vol. 6.

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.

The NoMA has introduced the possibility of granting an MA based on the English core texts. This “conditional” MA can be obtained in case the MAH has no intention of marketing the product in Norway.

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 Norwegian product information (incl. mock-ups) must be assessed and approved by the NoMA. 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.​

 

 

Changes in the routine for national approval of centrally authorised medicinal productshttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/changes-in-the-routine-for-national-approval-of-centrally-authorised-medicinal-productsChanges in the routine for national approval of centrally authorised medicinal products​General information to the MAH for centrally authorised medicinal products regarding European Union MA numbers.767
Norway as RMShttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/norway-as-rmsNorway as RMSNorway to act as Reference Member State (RMS) in Decentralized Procedure (DCP): Request can be submitted at any time. 766