The Agency shall, in collaboration with Member States, establish and maintain a Union pharmacovigilance database for the reporting and recording of suspected adverse events referred to in Article 73(2) (the ‘pharmacovigilance database’), which shall also include the information on qualified person responsible for pharmacovigilance as referred to in Article 77(8), the reference numbers of the pharmacovigilance system master file, the results and outcomes of the signal management process and results of pharmacovigilance inspections in accordance with Article 126.
Déanfaidh an Ghníomhaireacht, i gcomhar leis na Ballstáit, bunachar sonraí faireachais cógas de chuid an Aontais a bhunú agus a chothabháil chun teagmhais dhíobhálacha amhrasta dá dtagraítear in Airteagal 73(2) a thuairisciú agus a thaifeadadh (an “bunachar sonraí faireachais cógas”), lena n-áireofar freisin faisnéis ar an duine cáilithe a bheidh freagrach as faireachas cógas dá dtagraítear in Airteagal 77(8), uimhreacha tagartha mháistirchomhad an chórais faireachais cógas, torthaí an phróisis bainistithe comharthaí agus torthaí na gcigireachtaí faireachais cógas i gcomhréir le hAirteagal 126.