Fra og med 1. juni 2022 vil Legemiddelverket gå over til å godkjenne norsk preparatomtale, pakningsvedlegg og merkingstekst ved utstedelse av MT. Tidligere har Legemiddelverket krevd mock-ups, og ikke merkingstekst, i den nasjonale fasen.
Selv om mock-ups ikke lenger kreves før utstedelse av MT, må mock-ups likevel godkjennes før preparatet markedsføres i Norge.
English
The NoMA require submission of labelling in order to grant MAs
In order to grant Marketing Authorisations (MAs) in MRP/DCP, the NoMA now requires submission of labelling text, and not mock-ups of the labelling.
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. Please note that even though mock-ups of the labelling are no longer required before granting of the marketing authorisation, mock-ups will still need to be approved by NoMA before the medicinal product is placed on the Norwegian market.
For more information please see Marketing Authorisation applications.
