S.L. 483.7 Art. 9Reporting of serious adverse events and reactions. 4 [

The Licensing Authority shall ensure that:

(a) whenever as a Member State of destination, the Licensing Authority or its delegated body is notified of a serious adverse event or reaction that it suspects to relate to an organ that was received from another Member State, it shall immediately inform the competent authority or delegated body of the Member State of origin and transmit without undue delay to that competent authority or delegated body an initial report containing the information set out in Schedule I, S.L.483.07 INTENDED FOR TRANSPLANTATION

in so far as this information is available;

(b) whenever as a Member State of origin, the Licensing Authority or its delegated body it is notified of a serious adverse event or reaction that it suspects to be related to a donor whose organs were also sent to other Member States, the Licensing Authority or its delegated body, shall immediately inform the competent authorities or delegated bodies of each concerned Member State of destination and transmit them each an initial report containing the information set out in Schedule I;

(c) when additional information becomes available following the initial report, it shall be transmitted without undue delay;

(d) whenever Malta is the Member State of origin, the Licensing Authority or its delegated body shall, as a rule within three months of the initial report transmitted pursuant to paragraph (a) or (b), transmit to the competent authorities or delegated bodies of all Member States of destination, a common final report containing the information set out in Schedule II. The competent authorities or delegated bodies of the Member States of destination shall provide relevant information in a timely manner to the Licensing Authority or its delegated body. The final report shall be drawn up after collecting relevant information from all Member States involved.