​​​​​​​​​​​​​​​​​​​​​The different procedures for granting a marketing authorisation (MA) for a medicinal product are described in Notice to Applicants and on the main page for Regulatory affairs.

​​The application forms to be used are the same, regardless of the procedure chosen, and can be downloaded from:

Procedural guidances for MRP/DCP are available from HMA's website and for CP they are available from EMA's website:

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 MAs in MRP and DCP​

From 1 June 2022 the Norwegian Medicines Agency (NoMA) will change our routines and approve the summary of product characteristics (SmPC/SPC), package leaflet (PL) and labelling with the MA. Previously, NoMA required mock-ups of the labelling, and not labelling text, in the national phase of the MA procedure.​​

The Norwegian product information (summary of product characteristics (SmPC/SPC), package leaflet (PL) and labelling) will be approved with the marketing authorisation. Please submit the SmPC/SPC, PL and labelling as separate Word files and use the latest version of the QRD templates.

Human: Please submit the proposed final product information in Norwegian within 7 days after the End of Procedure. 

Veterinary: If the product information is not received within a period of 6​ months after the End of Procedure, the application will be considered to have been withdrawn.  ​

In case the product will be marketed in Norway

​​Before the product is placed on the Norwegian market, mock-ups of the labelling must be submitted for assessment and approval by NoMA, either within the MA-procedure or as an Article 61(3) notification (human)/VRA G.I.15.z (veterinary). In order to obtain approval of mock-ups within the MA-procedure, please submit mock-ups either in the national phase or within 2 months after the MA is granted. Mock-ups (in PDF-format) for each strength, pharmaceutical form and type of packaging intended to be marketed are required.

In case the product will not be marketed in Norway

​​If the product is not intended for the Norwegian market, the marketing authorisation could be granted without the Norwegian product information (‘conditional’ MA).  

​​Please send a confirmation within 2 weeks after the End of Procedure to pi@noma.no. Variations following the MA-procedure will consequently be approved without the Norwegian product information as well.​​​

Please note that this option does not apply to for line extension applications (human medicinal products) where the prior approved MAs are MAs with approved Norwegian product information. 

Change in marketing plans

​​I​​f 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 NoMA: 

  • ​SmPC/SPC
  • PL
  • labelling
  • mock-ups

The Norwegian product information should be submitted two months prior to the planned marketing date. 

​​​C​​hanges in the product information due to variation procedures approved after the MA-procedure, must be implemented in the Norwegian product information (marked with tracked changes). 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 NorwayThe 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 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.
List of pending marketing authorisation applicationshttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/list-of-pending-marketing-authorisation-applicationsList of pending marketing authorisation applications2854Pending applications for human and veterinary medicinal products in mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure.
Request for Norway to act as RMS in Decentralized Procedurehttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications/norway-as-rmsRequest for Norway to act as RMS in Decentralized ProcedureNorway to act as Reference Member State (RMS) in Decentralized Procedure (DCP): Request can be submitted at any time. 766

Oppdatert: 18.05.2022

Publisert: 19.08.2016

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