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Application for marketing authorisation

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Changes

  • : Removed information about the NoMAs new routine about also requiring labelling text to align with the Norwegian text.

Application forms for mutual recognition procedure (MRP)/decentralised procedure (DCP) and centralised procedure (CP) must be used when submitting MA applications. SmPC/SPC, PL and labelling must also be submitted and approved.

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​

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not received within a period of 6​ months after the End of Procedure, the application will be considered to have been withdrawn.  ​

If the medicinal product is to be marketed in Norway

If the medicinal product is to be marketed in Norway, mock-ups of the labelling must be submitted for assessment and approval by the NoMA, either within the MA procedure or as an Article 61(3) notification (human)/VRA G.I.15.z (veterinary). Mock-ups can also be submitted with a variation affecting the product information (type II variation for human medicinal products and VRA in chapter G for veterinary medicinal products). 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.

If the medicinal product is not to be marketed in Norway

If the medicinal product is not to be marketed in Norway, the marketing authorisation can be granted without the Norwegian product information (‘conditional’ MA).  

​​Please send a confirmation within 14 days after the End of procedure to pi@noma.no. Variations following the MA procedure will also be approved without the Norwegian product information.​​​

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

Changes 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.​​