Tidligere krevde Legemiddelverket kun mock-ups ved endringer i common merkingstekst. Mock-ups skal sendes inn ved designendringer. Det forutsettes at mock-ups er iht. gjeldende retningslinjer og Legemiddelverket kan be om å få tilsendt oppdaterte mock-ups ved behov. Ved endringer i både common merkingstekst og design, skal både norsk merkingstekst og mock-ups sendes inn.
For nasjonalt godkjente preparater vil det ikke være noen endringer i praksis på nåværende tidspunkt.
English
Norwegian labelling text in connection with MRP variations, renewals and 61(3)-notifications
From 1st of October 2022 the Norwegian Medicines Agency (NoMA) is going to approve Norwegian labelling when common labelling is revised through MRP variations, renewals and 61(3) notifications. Previously, NoMA required only mock-ups when the common labelling was changed. Please submit mock-ups if there are changes in design. Note that mock-ups must be in line with current guidelines and that NoMA may request updated mock-ups when needed. Mock-ups and Norwegian labelling shall be submitted if there are changes in both common labelling and design.
For nationally approved medicinal products there will be no changes at this point of time.
