S.L. 458.43 Art. 18Notification of serious adverse reactions.

(1)(a) The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reactions that are fatal or life-threatening is recorded and reported as soon as possible to the competent authorities in all the Member States concerned, and to the Ethics Committee, and in any case no later than seven days after knowledge by the sponsor of such a case, and that relevant follow-up information is subsequently communicated within an additional eight days.

(b) All other suspected serious unexpected adverse reactions shall be reported to the competent authorities concerned and to the Ethics Committee concerned as soon as possible but within a maximum of fifteen days of first knowledge by the sponsor.

(c) The Licensing Authority shall ensure that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention, shall be recorded.

(d) The sponsor shall also inform all investigators.

(2) Once a year throughout the clinical trial, the sponsor shall provide the Member States in whose territory the clinical trial is being conducted and to the Ethics Committee, with a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects’ safety.

(3) The Licensing Authority shall ensure that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are immediately entered in a European database to which, only the competent authorities of the Member States, the Agency and the Commission shall have access in accordance with regulation 11(1).

(4) The collection, verification and presentation of adverse event or reaction reports together with the decoding procedures for unexpected serious adverse reactions shall be carried out in accordance with the detailed guidance published by the Commission.