Information

ZL000_00_001e_WL / ZL000_00_002e_VZ / ZL000_00_002e_FO / ZL000_00_037e_MB / ZL301_00_001e_FO

ZL303_00_001d WL / ZL303_00_001d FO / BW303_00_001d WL

The new versions of the affected documents enter into force as of 1 July 2016. The previous versions of the forms will continue to be accepted during a transitional period lasting until 30 November 2016.

Die Antwort zu Frage 33 wurde bezüglich Vorgehen bei Änderungen der Packungselemente und bei Verzicht auf Musterpackungen ergänzt.

Die neuen Versionen der Merkblätter treten per sofort in Kraft.
(ZL000_00_016d_MB / ZL000_00_017d_MB)

In January 2016, Swissmedic modified the process for variations requiring notification pursuant to Art. 11, para. 2 of the Ordinance of 17 October 2001 on Therapeutic Products (TPO; SR 812.212.1).