​​The Norwegian Medicines Agency has of 1 December 2013 changed the wording of the national marketing authorisation for medicinal products granted through the European Commission, i.e. centralised procedure.

As of 1 December 2013 the national marketing authorisation letter will no longer include the listing of the EU sub-numbers (e.g. EU/1/13/9999/001, EU/1/13/9999/002 etc.) for each presentation. The national marketing authorisation letter will be stated with the EU main marketing authorisation number (e.g. EU/1/13/9999) only. The EU sub-numbers covered by the marketing authorisation will at any time be found in the last approved Annex A.

If a variation application results in new EU sub-number(s), no new national marketing authorisation letter will be issued. The previously issued marketing authorisation letter will still be valid and the EU sub-numbers covered by the marketing authorisation will be found in the newly approved Annex A.

Norwegian product information

Norwegian product information will no longer be attached to the letter of national approval of marketing authorisation and renewal for centrally authorised products. The approved Norwegian product information will be sent to the firm at day 237 from The European Medicines Agency together with all the other national translations.

Publisert: 19.08.2016