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. 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
firstname.lastname@example.org. 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:
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.
|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||The Norwegian Medicines Agency announces a need for more suppliers or alternatives on the market in Norway in case a possible shortage is identified due to withdrawal, cease of marketing or vulnerable supply.||1691|
|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.|
|List of pending marketing authorisation applications||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/list-of-pending-marketing-authorisation-applications||List of pending marketing authorisation applications||2854||Pending applications for human and veterinary medicinal products in mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure. |
|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.
|Time-limited exemption to continue batch control testing in the United Kingdom after Brexit||https://legemiddelverket.no/nyheter/time-limited-exemption-to-continue-batch-control-testing-in-the-united-kingdom-after-brexit||Time-limited exemption to continue batch control testing in the United Kingdom after Brexit||Marketing authorisation holders (MAH) may until the 12th of April 2019 request a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK's withdrawal from the European Union. ||2038|