Competent authorities shall lay down the necessary procedures to evaluate the results and outcomes of the signal management process recorded in the pharmacovigilance database in accordance with Article 81(2) as well as suspected adverse events reported to them, consider options for risk management and take any appropriate measures referred to in Articles 129, 130 and 134 concerning marketing authorisations.
Leagfaidh na húdaráis inniúla síos na nósanna imeachta is gá chun meastóireacht a dhéanamh ar thorthaí an phróisis bainistithe comharthaí a taifeadadh sa bhunachar sonraí faireachais cógas i gcomhréir le hAirteagal 81(2) mar aon le teagmhais dhíobhálacha amhrasta a tuairiscíodh dóibh, déanfaidh siad roghanna maidir le bainistíocht riosca a mheas agus déanfaidh siad aon bhearta iomchuí dá dtagraítear in Airteagal 129, Airteagal 130 agus Airteagal 134 a bhaineann le húdaruithe margaíochta.