Withdrawal

Withdrawal of the marketing authorisation pursuant to §23 AMG

The withdrawal of the marketing authorisation/registration can be either initiated by the holder of the marketing authorisation, or if necessary, requested ex officio by the BASG.


To withdraw (cancel) a marketing authorisation or registration, please complete the form F_Z59.

 

The date of the withdrawal is choosen and declared by the MAH, using the appropriate form.

Starting with the day the marketing authorisation has been cancelled, the product covered by this MA cannot be marketed any longer.

 

 

The cost of withdrawal is covered by the flat rate annual fee (Austrian Fee Regulation Appendix II, valid from 02.01.2014).
http://www.basg.gv.at/en/medicines/faq/annual-fee/

 




Created: 13.08.2012 | Page last modified: 12.10.2015

© Austrian Federal Office for Safety in Health Care
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