Competent authorities shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred in the territory of their Member State, within 30 days of receipt of the suspected adverse event report.
Déanfaidh údaráis inniúla taifead sa bhunachar sonraí faireachais cógas ar gach teagmhas díobhálach amhrasta a thuairiscíodh dóibh agus a tharla i gcríoch a mBallstáit, laistigh de 30 lá ón lá a fuarthas an tuairisc maidir leis an teagmhas díobhálach amhrasta.