​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.

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 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.​

 

 

Announcement of needed products in Norwayhttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/announcement-of-needed-products-in-norwayAnnouncement of needed products in NorwayThere will be an announcement of the wish to have more alternatives on the market in Norway in case a possible shortage is identified due to withdrawal, cease of marketing or vulnerable supply. 1691
Brexit related switch of RMShttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/brexit-related-switch-of-rmsBrexit related switch of RMSUnited Kingdom (UK) cannot be Reference Member State (RMS) for medicinal products approved in MRP/DCP after Brexit. MAHs of medicinal products with UK as the current RMS, are welcome to apply for Norway to act as the new RMS.1901United Kingdom as the current RMS? You are welcome to apply for Norway to act as the new RMS.
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
List of newly adopted marketing authorisations in Norwayhttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/list-of-newly-adopted-marketing-authorisations-in-norwayList of newly adopted marketing authorisations in NorwayA list of new marketing authorisations adopted via CP, MRP/DCP and national procedure, included parallel imported medicinal products, is published monthly.1876A list of new marketing authorisations adopted via CP, MRP/DCP and national procedure, included parallel imported medicinal products, is published monthly.
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

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