Number of copies to be submitted in MRP/DCP

The Norwegian Medicines Agency (NoMA) would like to clarify that one set only of the dossier is required for a MA application. There is no need to submit copies of any Modules.

This also applies to variations and renewals. Furthermore, there is no need to submit duplicate SPC’s, PL’s and labelling.   If possible, the NoMA is interested in receiving applications for MA’s in eCTD format.  Please be aware however, that our agency still needs a paper version of the application to be filed.  

For multiple applications it is only necessary to submit one set of Module 3, 4 and 5. Module 1 and 2 however, must be submitted for each application. Please write a thorough explanation in the accompanying letter.

Sist gjennomgått: 03.01.2006
Første gang publisert: 03.01.2006