For medicinal products authorised according to §7 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 (rmsagesat, basg-cmsagesat or natagesat) respectively.
For medicinal products registered according to §§11, 11a. or 12 AMG,
such a change is considered as a notification according to § 24 (6) AMG.
Please use the form Formblatt F_Z09
No use of this form is needed however, if the declaration, modification or deletion of a distributor in Austria is to be notified together with any other variation.
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).
Created: 18.07.2014 | Page last modified: 20.04.2015