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 without the Norwegian product information. 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
email@example.com. 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 Norway||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/announcement-of-needed-products-in-norway||Announcement of needed products in Norway||There 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 RMS||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/brexit-related-switch-of-rms||Brexit related switch of RMS||United 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.||1901||United 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 products||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/changes-in-the-routine-for-national-approval-of-centrally-authorised-medicinal-products||Changes 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 Norway||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/list-of-newly-adopted-marketing-authorisations-in-norway||List of newly adopted marketing authorisations in Norway||A list of new marketing authorisations adopted via CP, MRP/DCP and national procedure, included parallel imported medicinal products, is published monthly.||1876||A list of new marketing authorisations adopted via CP, MRP/DCP and national procedure, included parallel imported medicinal products, is published monthly.|
|Norway as RMS||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/norway-as-rms||Norway as RMS||Norway to act as Reference Member State (RMS) in Decentralized Procedure (DCP): Request can be submitted at any time.