Electronic submissions
From 1. January 2010 The Norwegian Medicines Agency (NoMA) will handle all procedures electronic only. Paper copies will then no longer be necessary to submit.
The applicant must provide one electronic copy of the dossier. However, when NoMA is acting as (co-)rapporteur or RMS (Reference Member State), we require three electronic copies of the dossier.
NoMA will follow the international standards regarding electronic formats, i.e. eCTD and NeeS. For all procedures eCTD will be the recommended format, and from 1. January 2010 eCTD will be mandatory for Centralised procedure.
For more information regarding eCTD submissions, please read the information at the following web sites:
Human medicinal products:
Notice to Applicant – vet
From 1. January 2010 The Norwegian Medicines Agency (NoMA) will handle all procedures electronic only. Paper copies will then no longer be necessary to submit.
The applicant must provide one electronic copy of the dossier. However, when NoMA is acting as (co-)rapporteur or RMS (Reference Member State), we require three electronic copies of the dossier.
ICH (International Conference on Harmonisation) standards for CTD is currently only developed for human medicinal products. Dossiers of veterinary medicinal products will follow the traditional NtA format.
Please find more information regarding electronic dossier for veterinary medicinal products here:
Veterinary medicinal products:
Sist gjennomgått: 12.02.2010
Første gang publisert: 21.10.2009