Distributor in Austria
For medicinal products authorised according to §7 AMG and for medicinal products registered according to §§11, 11a. or 12 AMG, the declaration, modification or deletion of a distributor in Austria is considered as a notification.
This can be included with any text-relevant variation, or if no such pending, simply notified by sending the information to the appropriate mailbox (rmsbasg.gvat, basg-cmsbasg.gvat or natbasg.gvat) respectively.
There are no costs arising with this notification, being already covered by the flat rate annual fee - according to Austrian Fee Regulation Annex II (valid from 02.01.2014).