26 Mar News from Austria: Notification obligation for medicine shortages
Medicine shortages in Austria are published currently on the Federal Office for Safety in Health Care (BASG) website in the “Shortages catalogue”.
The obligation of the authorization holder (and all other authorized bodies) to secure the supply is regulated in § 57a (1) AMG (Austrian Medicinal Products Act). Notifications for medicine shortages due to manufacturing or GMP problems acc. to §34 AMBO (Regulation on the Austrian Medicinal Products Registry) 2009 are obligatory. All other notifications are desired for supply shortages lasting longer than 14 days, but they are not mandatory yet.
An amendment of the AMG, which will include the obligation to announce the supply shortage for all prescription medicines, is in the planning stage.
Since February 1, 2018, MAHs or authorized representatives of the MAH have the option of reporting supply shortages via the eServices “Authorisation and Lifecycle of Medicinal Products”.
Further information on the homepage of AGES under the following link.