It is a condition of a licence for a procurement activity or a transplantation activity1 for the licence holder to have in place operating procedures for the management of a serious adverse event or a serious adverse reaction2. The licence holder is required to rapidly report to the Authority relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation, and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those
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