у орб, кяо а уки н р пеип саео а рдка а ааа дкт е а ааа птеа от д ф нц о иа рд укнт н поут н пзр и оао н пзр.
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys 000001/ 15 (13 October 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.