establishing and maintaining a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;
córas a bhunú agus a chothabháil lena n-áirithítear go mbailítear agus go ndéantar taifead ar gach teagmhas díobhálach amhrasta a cuireadh in iúl do shealbhóir an údaraithe margaíochta chun go mbeidh rochtain orthu ar láithreán amháin ar a laghad san Aontas;