Registreringsindehaveren skal sikre sig, at farmakovigilancesystemet, som beskrevet i version DescPhSys000001/ 4 dateret 12/ 12/ 2006, opdateret d.
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys000001/ 4 dated 12/ 12/ 2006– Updated: