S.L. 458.35 Art. 25Reports of serious suspected adverse reactions.

(1) The Authority shall, within fifteen days following the receipt of the reports of serious suspected adverse reactions referred to in regulation 21, submit the reports electronically to the Eudravigilance database.

(2) The Authority shall, within ninety days from the receipt of reports referred to in regulation 21, submit reports of non-serious suspected adverse reactions electronically to the Eudravigilance database.