Exalon: Spanish Medicines Agency updates national electronic submission guidance

The new version puts more emphasize on the possibility to switch dossier formats. The general schedule only allows to switch from paper -> NeeS -> eCTD or directly from paper -> eCTD but not backwards. Exceptions may be allowed in very rare cases that need to be duly justified (e.g. change of ownership etc.).

To find more information please find below mentioned Exalon weblink

http://www.exalon.com/ectd-news/news-details/article/spanish-medicines-agency-updates-national-electronic-submission-guidance.html