Marketing authorisation holders shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred within the Union or in a third country or that have been published in the scientific literature with regard to their authorised veterinary medicinal products, without delay and no later than within 30 days of receipt of the suspected adverse event report.
Déanfaidh sealbhóirí údaruithe margaíochta taifead sa bhunachar sonraí faireachais cógas ar gach teagmhas díobhálach amhrasta a tuairiscíodh dóibh agus a tharla san Aontas nó i dtríú tír nó a foilsíodh sa litríocht eolaíoch maidir lena dtáirgí íocshláinte tréidliachta údaraithe, gan mhoill agus tráth nach déanaí ná 30 lá ón lá a fuarthas an tuairisc maidir leis an teagmhas díobhálach amhrasta.