The marketing authorisation holder shall record, at least annually, all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature in the pharmacovigilance database.
Déanfaidh sealbhóir an údaraithe margaíochta taifead sa bhunachar sonraí faireachais cógas, go bliantúil ar a laghad, ar thorthaí uile an phróisis bainistithe comharthaí, lena n-áirítear conclúid ar an gcothromaíocht sochair-riosca, agus i gcás inarb iomchuí, tagairtí don litríocht eolaíoch ábhartha.