S.L. 458.35 Art. 17Eudravigilance database.

Marketing authorisation holders shall submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004, hereinafter referred to as the "Eudravigilance database", information on all serious suspected adverse reactions that occur in the European Union and in third countries within fifteen days following the day on which the marketing authorisation holder concerned gained knowledge of the event.