Submission of product information

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.

For human medicinal products, please submit the proposed final product information in Norwegian within 7 days after the End of Procedure. 

For veterinary medicinal products the application will be considered withdrawn, if the product information is not received within a period of 6​ months after the End of Procedure.

If the medicinal product is to be marketed in Norway

Before the medicinal product may be marketed in Norway, mock-ups must be submitted to DMP for assessment and approval. If approval of the mock-ups is sought in connection with the marketing authorisation procedure, the mock-ups must be submitted during the national phase. Please submit mock-ups in PDF format for each strength, pharmaceutical form, and pack type to be marketed.

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 may be granted without Norwegian product information (‘conditional’ marketing authorisation). Please submit confirmation of this within 2 weeks after the end of the procedure to pi@noma.no. Variations submitted after the marketing authorisation procedure will also be approved without Norwegian product information.

Please note that a marketing authorisation without Norwegian product information is not possible for line extension applications where previously approved marketing authorisations have been granted with Norwegian product information.

Changes in marketing plans

If, at a later stage, it is decided that the medicinal product is to be marketed, the product information (incl. mock ups) must be submitted 2 months prior to the planned launch.

Any changes to the English product information approved after the marketing authorisation procedure must be implemented in the Norwegian product information and shown using tracked changes. Please list the relevant procedure numbers and approval dates in the submission.